Almirall and BioFocus : collaboration to find new hit compounds against key targets

November 15, 2011 - Targets are related to the treatment of respiratory and inflammatory conditions -

The pharmaceutical company Almirall S.A. and BioFocus, an integrated drug discovery partner, announced they have entered into a collaboration agreement to find new hit compounds against key targets of interest to Almirall. These compounds will be used to support projects aimed at the treatment of respiratory and inflammatory conditions.

Under the terms of the collaboration, BioFocus will apply its screening technologies and compound collections to an undisclosed number of Almirall projects.

“We have been impressed by the depth of the BioFocus technology platforms, the size, content and diversity of the available compound decks and the obvious strength and experience of the scientists that will be engaged on our projects working on respiratory and inflammatory conditions”, said Dr. Bertil Lindmark, CSO, Executive Director R&D of Almirall.

“We are delighted to form a drug discovery alliance with one of Europe’s leading research-based pharmaceutical companies,” added Dr. Kate Hilyard, VP Biological Sciences, BioFocus... BioFocus' Press Release - Almirall's Press Release -

Selecta Biosciences : Phase 1 Clinical Study of SEL-068, a First-in-Class Synthetic Nicotine Vaccine for Smoking Cessation and Relapse Prevention

November 21, 2011 - First Clinical Program for Selecta's Synthetic Vaccine Particle Platform with Broad Potential for a Range of Therapeutic Applications Including Infections, Cancer, Allergies, and Autoimmune Diseases –

Selecta Biosciences, Inc., a biopharmaceutical company developing a new class of synthetic vaccines and immunotherapies, announced that it has initiated a Phase 1 clinical trial to assess the safety, tolerability and pharmacodynamic profile of SEL-068, a nicotine vaccine candidate for smoking cessation and relapse prevention. SEL-068 is the first product candidate to enter clinical evaluation from Selecta's proprietary Synthetic Vaccine Particle (SVP™) Platform, and has the potential to become the first nanoparticle vaccine that is synthetically engineered, distinct from conventional biological vaccine manufacturing processes.

"This is the first time ever that a fully integrated synthetic, nanoparticle vaccine is being tested in human clinical trials and is a very important milestone in the translation of Selecta's SVP technology," said Ulrich von Andrian, Ph.D., M.D., Edward Mallinckrodt Jr. Professor of Immunopathology at Harvard Medical School and Selecta co-founder. "Selecta has demonstrated its ability to rationally design immunotherapeutics and induce a robust targeted immune response. SVP technology will revolutionize the way vaccines will be designed, produced and applied."

The Phase 1 clinical study of SEL-068 is a double-blind, placebo-controlled, ascending dose study in healthy, non-smoking and smoking volunteers. In addition to safety, the study will evaluate the vaccine's potency through the measurement of concentrations of nicotine-specific antibodies. Selecta expects to report initial results from this Phase 1 study in the first half of 2012.

Because SEL-068 is fully synthetic, the immune response is entirely focused on nicotine and avoids off-target responses to biological carriers typically used with other vaccine technologies. The resulting high antibody concentrations induced by SEL-068 have the potential to absorb inhaled nicotine, preventing it from reaching the brain and triggering the addictive response... Selecta Biosciences' Press Release -

Quest Diagnostics : Launch of Simplexa(TM) Direct Test for Influenza and Respiratory Viruses in Europe

Nov. 1, 2011 - Focus Diagnostics product eliminates nucleic-acid sample extraction with proprietary technology, for faster testing -

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, announced the CE mark and European availability of the Simplexa Flu A/B & RSV Direct test on the 3M(TM) Integrated Cycler. The new test, from the company's Focus Diagnostics business, uses a proprietary technique to eliminate nucleic-acid sample extraction, a time-consuming process required by other molecular test products, for faster results reporting.

"Simplexa Direct chemistry employs a novel technology that overcomes a critical limitation found in most molecular test kits on the market: the need for extraction of nucleic acids," said Maurice Exner, Ph.D., vice president of research and development, Focus Diagnostics. "With this advance, molecular testing will be far easier and faster for labs to perform than before. We believe the Simplexa Direct method is an important step toward enabling a greater range of healthcare professionals to access quality molecular testing. We look forward to introducing our first Simplexa Direct product, for influenza and respiratory syncytial virus testing, to laboratories in Europe."

Nucleic-acid extraction is a process requiring specialized molecular equipment and trained personnel. It involves extracting DNA or RNA from a blood, plasma or other specimen type for testing. The nucleic-acid extraction process, used in most commercial molecular test kits, can add approximately 60 to 90 minutes to total testing time. Focus Diagnostics has replaced the process with a proprietary reaction-mix technique. The company expects to use the proprietary technology in future Simplexa products.

Simplexa Flu A/B & RSV Direct is an addition to the influenza and respiratory franchise of award-winning FDA-cleared and CE-marked assays available through Focus Diagnostics... Quest Diagnostics' Press Release - Focus Diagnostics' Press Release -

VentriPoint : Clinical Studies of Pulmonary Arterial Hypertension Application of Right Heart Analysis System

Nov. 1, 2011 - The University of Chicago Completes First Patient -

VentriPoint Diagnostics (TSX VENTURE:VPT)(PINK SHEETS:VPTDF) announces the University of Chicago has secured a VentriPoint Medical System (VMS™) and has begun the clinical evaluation of the database for patients with Pulmonary Arterial Hypertension (PAH).

The study will be led by four highly regarded cardiac specialists from the University of Chicago; Dr. Roberto Lang, former President of the American Society of Echocardiography and Director of the Echo Lab; Dr. Mardi Gomberg, expert clinician and researcher in the field of pulmonary hypertension; Dr. Amit Patel, Director of Cardiac MRI; and Dr. Benjamin Freed, Lead Cardiologist.

"I expect that an assessment of RV volume and function using the VMS™ will become part of the routine clinical ultrasound evaluation for patients at risk for PAH," stated Dr. Roberto Lang. "A simple way to detect and monitor PAH is gravely needed and this methodology will be extremely useful to quantify interventions (therapeutic and surgical) performed on the right ventricle," Dr. Lang added.

It is anticipated this first clinical study will take four to six weeks and will verify the accuracy of the system in patients known to have PAH. If successful, a multicenter clinical trial will be initiated to compare VMS™ with MRI as part of a submission to the FDA as part of a 510K submission.

Dr. George Adams, VentriPoint President and CEO stated, "The Company will leverage the success of the VentriPoint technology with congenital heart disease to address the needs of a significantly larger population of patients at risk for pulmonary hypertension."

The VMS™ is for investigational use only in the United States and approved for clinical use in Canada and Europe... [PDF] VentriPoint Diagnostics' Press Release -

Air Products : BIG Supports O2 Medical Grade to Help Patients in Flood Areas

October 25, 2011 - BIG Supports O2 Medical Grade to Help Patients in Flood Areas -

Management of Bangkok Industrial Gas Co., Ltd. or BIG led by Senior Executive Director Chaiwat Niyomkarn (5th from right), recently teamed up to Ayudhya province to present 70 cylinders of oxygen medical grade to the Center of Flood Relief in Ayudhya to help patients get stuck there.

The support will continue until the flood situation is eased.

This inundated is the worst of its kind as there are many victims waiting for helps. Stocks of oxygen are critical as the delivery was very difficult and some gas operations are closed. BIG has contacted the Public Health Ministry to offer the help... Bangkok Industrial Gas' Press Release - Air Products' Press Release -

ChemDiv Research Institute at ChemRar Hi-Tech Centre : Collaboration and License Option agreement with Novartis Institute for Tropical Diseases to battle Tuberculosis

October 6, 2011 - ChemDiv Research Institute (CDRI) at the ChemRar Hi-Tech Centre announced that it has signed collaboration and license option agreement with the Singapore based Novartis Institute for Tropical Diseases (NITD) to undertake discovery and development of patentable chemical compounds to find new, faster cures for Tuberculosis.

Tuberculosis (TB) is a major health problem in the world today, responsible for nearly 2 million deaths per year. One third of the world's population are infected with latent TB, and ~5-10% of infected individuals may develop active TB within their lifetime. Current treatment of TB takes more than half a year, much longer than treatment for other infectious diseases. Emergence of multi drug resistant tuberculosis and TB co-infection with HIV are escalating the need for finding new drugs for curing the TB.

CDRI has prepared and delivered to NITD a focused library consisting of thousands of compounds that will be screened in a cell-based assay to identify lead molecules that are active against the mycobacterium... ChemDiv's Press Release -

Calypso Medical Technologies : FDA Grants Calypso Medical IDE Approval for Pivotal Lung Cancer Study

Sept. 27, 2011—Calypso Medical Technologies, Inc., developer of real-time localization technology used for precise tumor tracking, announced that the U.S. Food and Drug Administration (FDA) granted Investigational Device Exemption (IDE) approval for its clinical study evaluating real-time tracking of lung cancer tumors during radiation delivery. Patient enrollment is planned at Washington University in St. Louis, and the Cancer Treatment Centers of America in Tulsa, Oklahoma. Investigators in the United States will implant three anchored Beacon® transponders in patients’ lungs and use the Calypso® System to precisely track tumor location and movement during lung cancer radiation therapy.

“We are very pleased to see Calypso begin the U.S. portion of this important clinical study to assess the clinical experience and safety of anchored transponders in the small airways of patients with lung cancer,” said Daniel Nader, DO, FCCP, national clinical director, pulmonary/critical care and interventional pulmonologist at the Cancer Treatment Centers of America at Southwestern Regional Medical Center in Tulsa, Okla. “The five-year survival rate for lung cancer is grim at just 16 percent; however, with the Calypso System’s ability to track this high-velocity repetitive motion, treatment options for lung cancer patients may expand to include earlier and more aggressive radiation treatment.”

Calypso began the pivotal study in October 2010 at Tygerberg Hospital, affiliated with the University of Stellenbosch, in South Africa, located outside of Cape Town. The multi-center study is also underway at the University of Heidelberg in Germany, and the University Hospital Basel in Switzerland. Early data on the implantation of the electromagnetic transponders in lung cancer patients, and the use of the Calypso System for real-time tracking in these patients will be presented at the upcoming American Society of Radiation Oncology (ASTRO) meeting in Miami... Calypso Medical Technologies' Press Release -

Kinexus : Proteomics Study Reveals Profound Gender-related Differences in Lung Responses to Cigarette Smoke

Aug. 4, 2011 - Kinexus Bioinformatics Corporation, a world-leader in molecular intelligence research, announced the publication of the results from a major study undertaken in collaboration with the A. W. Spears Research Center, Lorillard Tobacco Company to uncover cigarette smoke protein biomarkers. The findings appear in the Journal of Proteome Research and reveal profound differences in the responses of many lung proteins in male and female rats exposed to dilute mainstream smoke for 3 hours per day for 5 consecutive days. The data is also available online with open-access in the Kinexus KiNET DataBank.

Using the Kinexus integrated platform of proteomics discovery services, the researchers initially analyzed lung lysates that were pooled from similar groups of exposed rats using antibody microarrays that tracked over 500 key cell signaling proteins for their abundance and their phosphorylation status. Phosphorylation acts as an on/off switch for most of the 23,000 proteins encoded by the human genome. Promising leads from these antibody microarrays were confirmed by immunoblotting studies, and they were further monitored using microarrays that were printed with lysates from individual animals as separate spots on the chips. Over 20 signal transduction and stress proteins were found to be consistently and significantly altered with the short term cigarette exposures, and bioinformatics was used to show how these proteins connected within cell signaling networks.

Smoke-altered proteins regulate apoptosis, proliferation, stress response, cell structure, cell migration and inflammation. The female rats demonstrated much higher sensitivity to low doses of cigarette smoke and resultant changes in these protein pathways than their male counterparts. The study utilized proteomic technologies to enable a systematic approach to understanding lung proteins altered by smoke... [PDF] Kinexus Bioinformatics' Press Release -

Tarix Pharmaceuticals : TXA127 Granted Orphan Drug Status for Treatment of Pulmonary Arterial Hypertension

September 27, 2011 – Tarix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted TXA127, the Company’s lead peptide drug candidate, orphan drug status for the treatment of pulmonary arterial hypertension (PAH). Emerging science has demonstrated that the naturally occurring peptide angiotensin (1-7), the pharmaceutical ingredient in TXA127, exhibits a protective effect in animal models of PAH, suggesting a potentially beneficial role for TXA127 against this disease.

 Rick Franklin, M.D., Ph.D., Chief Executive Officer of Tarix, commented, “We are extremely pleased that TXA127 has been granted orphan drug status for this indication by the FDA. This is an important development for Tarix and is part of our strategy to build a portfolio of products using TXA127 and our synthetic peptide PanCyte to treat a variety of serious pulmonary diseases.”

 Tarix is developing TXA127 for multiple therapeutic indications, including enhancement of engraftment following peripheral blood and cord blood stem cell transplantation and acute respiratory distress syndrome (ARDS). In 2010, TXA127 was granted Orphan Drug designation as a treatment to enhance engraftment in patients receiving a stem cell transplant. TXA127 has also received Orphan Drug designation for the treatment of Myelodysplastic Syndrome (MDS)... Tarix Pharmaceuticals' Press Release -

ABI (Akers Biosciences, Inc.) Starts Clinical Trials for Breath PulmoHealth “Check” Rapid Assay

24 August 2011 - Akers Biosciences, Inc. (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, is pleased to announce that clinical trials (the “Trials”) have commenced for the COPD version of the Company’s Breath PulmoHealth Check suite of rapid testing products. The Trials, which are being conducted in Clearwater, Florida (USA), will comprise at least 200 subjects with early- and late-stage chronic obstructive pulmonary disease (COPD), and the individuals will vary in the level of control of their disease. The protocol is designed to provide the clinical data needed to support regulatory submissions in the USA and EU in H1 2012.

 The Breath PulmoHealth “Check” COPD detector (“COPD detector”) identifies biomarkers that signal the breakdown of lung tissue in patients with COPD. Smoking is the leading cause of COPD, but exposure to second-hand smoke, pollution, and certain gases or fumes can also be causative factors leading to this chronic pulmonary condition. Globally, approximately 210 million individuals are being treated for COPD, but each of the 1 billion smokers is at risk for the disease... [PDF] Akers Biosciences' Press Release -

Aethlon Medical : Sarcoma, Lung Cancer, Prostate Cancer, Metastatic Melanoma, and Head and Neck Cancer Studies

Aug. 24, 2011 -- Aethlon Medical, Inc. (OTCBB:AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced that it has entered into an agreement with the Sarcoma Oncology Center to study the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. Exosomes released by cancer have recently emerged as a novel therapeutic target in cancer care, as they have been implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes may assist tumors in evading the response of the immune system. At present, there is no therapeutic drug candidate to inhibit the deleterious roles of cancer-released exosomes. The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including HIV and Hepatitis C virus. The device has also demonstrated the ability to capture cancer-released exosomes from cell culture and human ascites fluids [...]

 "The opportunity to test the ability of our Hemopurifier® to remove exosomes from the blood of cancer patients represents an important step in our effort to improve cancer care," stated Aethlon Chairman and CEO, Jim Joyce. "Additionally, we will have the privilege of working with Dr. Sant Chawla, a leading authority in the sarcoma oncology field and his team at the Sarcoma Oncology Center."

 The study will be conducted in collaboration with The Sarcoma Oncology Center based in Santa Monica, California. The Sarcoma Oncology Center is one of the most sought after research centers for the clinical testing of new therapeutic candidates against sarcomas and other forms of cancer. [...] The lead investigator of the study is Dr. Sant P. Chawla (About Dr. Chawla). Dr. Chawla noted, "This clinical histological study is a critical validation step in Aethlon's Hemopurifier® strategy for cancer that we hope will set the stage for planned therapeutic trials in cancer patients. The concept of 'subtractive therapy', eliminating a major mechanism of tumor progression and resistance to drugs, represents a potential breakout solution that needs to be tested in the clinic." The initial study will quantitate and capture exosomes ex-vivo, from blood samples of patients with advanced cancers. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma... Aethlon Medical's Press Release -

Helsinn : Global Pivotal Phase III Clinical Program to Evaluate Anamorelin in Non-Small Cell Lung Cancer-Associated Anorexia/Cachexia

Aug. 23, 2011 -- Helsinn, a Swiss-based pharmaceutical company, announced that its US subsidiary, Helsinn Therapeutics, has enrolled the first patient in the company's pivotal Phase III clinical program of anamorelin HCl for the treatment of anorexia/cachexia in patients with advanced non-small cell lung cancer (NSCLC).

The anamorelin clinical program includes two pivotal Phase III studies to be run in parallel, named ROMANA-1 and ROMANA-2. Each is a randomized, double-blind, placebo controlled, multicenter global trial that is expected to enroll up to 477 patients. In addition, patients will have the option of continuing treatment in a 12-week safety extension study called ROMANA-3. The primary efficacy endpoints of ROMANA-1 and 2 include a measure of difference in the change in lean body mass and muscle strength in patients with advanced NSCLC-associated weight loss. Pharmacokinetic and additional safety measures will also be evaluated... [PDF] Helsinn's Press Release -

QIAGEN and Pfizer partner to develop companion diagnostic for novel compound in global clinical trials for lung cancer

August 16, 2011 - QIAGEN (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA) announced it has entered into a partnership with Pfizer Inc. (NYSE: PFE) for the development of a companion molecular diagnostic test for use with an investigational Pfizer compound in global clinical development for treatment of non-small cell lung cancer (NSCLC). Financial terms of the agreement were not disclosed.

Pfizer's investigational compound, dacomitinib (PF-00299804), is an oral inhibitor of HER-1 (EGFR), HER-2 and HER-4 tyrosine kinases. The HER (human epidermal growth factor receptor) signaling pathway plays a role in the complex process of cell growth and metastasis, making it a target for anti-cancer drugs.

 QIAGEN's proposed companion diagnostic will be based on its proprietary KRAS assay technology, which reliably detects mutations of the KRAS gene that are frequently found in human cancers. Because EGFR inhibitors are generally effective in patients without these KRAS mutations, the QIAGEN assay can be useful in identifying patients most appropriate for EGFR-inhibitor therapies. QIAGEN recently submitted the application for Premarket Approval (PMA) for KRAS companion diagnostics to the FDA for use with two other, separate drugs targeting metastatic colorectal cancers. The Pfizer drug companion diagnostic test is being specifically developed for use in lung cancer tissue. It uses the same core assay component as the therascreen KRAS RGQ kit for colorectal cancers but varies in the workflow to allow for lung tissue-specific sample technology in a fully automated workflow... QIAGEN's Press release -

PNEUMACARE’S REVOLUTIONARY MEDICAL MONITORING TECHNOLOGY

01 Aug 2011 - SUCCESSFUL FINANCING ROUND ACCELERATES THE DEVELOPMENT OF PNEUMACARE’S REVOLUTIONARY MEDICAL MONITORING TECHNOLOGY - PneumaCare Limited is pleased to announce that it has completed a successful investment round of £2.0m. The financing was led by new investor Sud Investments, together with a group of existing investors including Cambridge Enterprise, Cambridge Capital Group and members of the Cambridge Angels group.

‘This funding, and the recent CE mark approval for our PneumaScan™ product, puts PneumaCare in a strong position to address the needs of the spirometry and respiratory illness market,’ says Ward Hills, CEO of PneumaCare. ‘It will enable us to accelerate the commercial development of the PneumaScan™ product family, for the benefit of the growing numbers of patients.’

PneumaCare has worked closely with another of its investors, Plextek Ltd, to transform 3D motion capture technology, originally developed for the computer game and film industries, into its lead product. PneumaScan™ uses light to measure and monitor how deeply and how quickly a patient is breathing, and what muscle groups are being used. It achieves the same results as the traditional spirometer but has several advantages, the crucial one being that no physical contact is necessary... PneumaCare's Press Release -

Nycomed and Orion : to collaborate on Easyhaler® for asthma and COPD

4 August 2011 - Orion Corporation (Nasdaq OMX Helsinki: ORNAV and ORNBV) announced that it has entered into a collaboration agreement with Nycomed for the co-marketing of Easyhaler® combination products for the treatment of asthma and COPD in the major European countries and an exclusive license and distribution arrangement for the Middle East and North Africa region (MENA). Both companies will commercialise Easyhaler combination products under their own brands accompanied by the Easyhaler umbrella brand.

The agreement covers Orion’s new Easyhaler combination products for treatment of asthma and COPD (chronic obstructive pulmonary disease). Orion is developing a budesonide-formoterol formulation that combines budesonide as an anti-inflammatory agent and formoterol as a long-acting bronchodilator. In addition, Orion has another Easyhaler® research programme in progress to develop a fluticasone-salmeterol formulation. In this formulation fluticasone acts as an anti-inflammatory agent and salmeterol acts as a long-acting bronchodilator. Both these combination products are included in the co-marketing agreement.

Respiratory is a key strategic area for Nycomed, including the COPD treatment Daxas® (roflumilast), Alvesco® (ciclesonide) for asthma, and Omnaris® for allergic rhinitis. The collaboration with Nycomed reinforces Orion’s presence throughout Europe and is in line with Orion's strategy to strengthen its marketing position in Europe and the sales coverage through partnerships. The co-marketing area - in which both companies present their own product brands under the Easyhaler umbrella brand - covers the major European countries including Austria, the Benelux countries, France, Germany, Greece, Italy, Poland, Portugal, Spain and Switzerland. Orion will retain exclusive marketing rights for the Nordic countries, U.K. and Eastern Europe where the company is currently promoting single molecule Easyhaler products. Orion will exclusively manufacture the Easyhaler combination products covered by the agreement... Orion's Press Release - Nycomed's Press Release -

Cerulean Pharma : First Patients in Randomized Phase 2 Clinical Study of CRLX101 in Non-Small Cell Lung Cancer

July 12, 2011 - Cerulean Pharma Inc., a leader in designing and developing tumor-targeted nanopharmaceuticals, announced the dosing of the first patients with CRLX101 in a randomized, controlled non-small cell lung cancer (NSCLC) Phase 2 clinical trial.

The initiation of this Phase 2 study marks a major milestone in the clinical advancement of nanopharmaceuticals,” said Oliver Fetzer, Ph.D., president and chief executive officer of Cerulean. “Cerulean is excited to develop CRLX101 as a potential new therapy for lung cancer patients who otherwise have limited treatment options.”

The primary objective of the Phase 2 study is to assess the efficacy and safety of CRLX101 in advanced NSCLC patients whose disease has progressed following one or two prior regimens of therapy. Approximately 150 patients are anticipated to be enrolled in this study at 26 clinical trial sites in Russia and Ukraine. Patients will be randomized 2:1 to receive either CRLX101 plus best supportive care or best supportive care, respectively. Patients will be evaluated for overall survival, progression-free survival, tumor response, and pharmacokinetic parameters... [PDF] Cerulean Pharma's Press Release -

Verisante Technology : Pilot Study Results for Lung Cancer Detection System

July 6, 2011 - Verisante Technology, Inc. (TSX-V: VRS; OTCQX: VRSEF) is pleased to announce that the results of a pilot study on lung cancer detection will be published in the prestigious Journal of Thoracic Oncology in July. The results of the pilot study indicate that the Company’s system technology could set a new standard for the early detection of lung cancer.

The Company owns, co-owns, or has the exclusive rights to all of the technology used in the pilot study, which was generously funded by the Canadian Institutes of Health Research (“CIHR”) and the Canadian Cancer Society.

Verisante is currently developing a commercial prototype of the laser Raman system, the Verisante Core™, licensed from the BC Cancer Agency which, when combined with the ClearVu™ and ClearVu Elite™ systems recently acquired from Perceptronics Medical Inc., reduces false positives by over 75% compared to current endoscopic methods.

The ClearVu™ system is a simultaneous white light and fluorescence real time video accessory which is used with a fiberoptic bronchoscope for lung cancer examinations. The ClearVu Elite™ has the addition of real time reflectance and fluorescence spectral analysis to assess the malignancy potential of suspicious lesions. The technology is complementary to the Verisante Core™ which uses rapid Raman spectral analysis for the detection of lung cancer... Verisante Technology's Press Release -

PneumRx, Inc. Raises $33 Million in Capital

January 4, 2011 - PneumRx, Inc., a medical device company dedicated to bringing innovation and improvements to the treatment of lung disease, announced that it has raised $33 million in working capital commitments. The oversubscribed round was led by Forbion Capital Partners and co-led by Endeavour Vision, both leading venture capital firms from Europe, and also included a prominent strategic corporate partner. The syndicate was joined by existing investors Adams Street Partners, Telegraph Hill Partners, Alta Partners, and Spray Venture Partners, among others. Silicon Valley Bank and Leader Ventures also contributed to the capital raise in PneumRx.
PneumRx recently established a subsidiary in Germany, PneumRx GmbH, and has begun selling its innovative RePneu Lung Volume Reduction Coil (LVRC) System in Europe. It plans to use the funds to expand European commercialization and to conduct an FDA-approved pivotal clinical trial to support a PMA application. PneumRx expects to begin its pivotal clinical trial in early 2011 and intends to submit its pivotal trial results to support a PMA application to be able to sell the RePneu LVRC System in the United States.
The RePneu LVRC System is a minimally invasive device intended to improve lung function in emphysema patients by bronchoscopically implanting Nitinol coils into the lungs to compress damaged tissue (lung volume reduction) and restore elastic recoil to the lung. This treatment offers a minimally invasive alternative to lung volume reduction surgery, and works independently of collateral ventilation. More than 1500 LVR Coils have been implanted to date in over 170 procedures. The LVRC System is CE Marked and is currently available in select markets in Europe, with plans for broader expansion... [PDF] PneumRx's Press Release -

MolMed : Results of three Phase II trials in lung cancer indications confirm safety and antitumour activity of NGR-hTNF

June 2011 - Promising clinical activity in a randomised trial in non small cell lung cancer - Prolonged clinical benefits in small-cell lung cancer - Long-term advantage of a more frequent administration in mesothelioma – MolMed S.p.A. (Milan:MLM) reports new clinical data of its investigational anticancer drug NGR-hTNF in three different lung cancer indications, which will be presented on 4 June at the 47th ASCO Annual Meeting in Chicago. Initial analysis of a randomised Phase II trial in non-small cell lung cancer, along with top line results of a Phase II trial in small-cell lung cancer and long-term follow up of a Phase II trial in mesothelioma, confirm the favourable safety profile as well as the promising antitumour activity of NGR-hTNF.
Claudio Bordignon, MolMed’s chairman and CEO, comments: "These new data represent another important milestone in the development of NGR-hTNF and show our commitment in the treatment of pulmonary tumours, from mesothelioma to non-small cell and small cell lung cancers. These are the results of a intense and diversified effort in clinical development: we have now ongoing several trials including a pivotal Phase III trial in mesothelioma and a randomised Phase II trial in non-small cell lung cancer. In the treatment of mesothelioma, we expect to have the final results of the Phase III study in 2013, while the results of the long-term analysis of the completed Phase II study confirm the efficacy of our treatment-intensification strategy. In non-small cell lung cancer, the first evaluation of the randomised Phase II trial suggests antitumour activity that is particularly evident in patients with squamous histology, and in patients with adenocarcinoma who received maintenance treatment with NGR-hTNF after completion of chemotherapy. These are important results, because this evidence, together with the lack of cumulative toxicity, led us to explore a new treatment option for NGR-hTNF as maintenance therapy. The first application of this new approach is represented by a randomised Phase II trial of first-line therapy in mesothelioma now open for patient accrual." [PDF] MolMed's Press Release -

Scancell : new vaccine for the treatment of lung cancer

Scancell Holdings Plc, (AIM: SCLP), the developer of therapeutic cancer vaccines, announces that a treatment utilising a DNA vaccine based on its ImmunoBody® technology, in combination with Homspera®, an adjuvant developed by ImmuneRegen BioSciences, Inc.® has produced encouraging anti-tumour results in animal models.

The vaccine, known as SCIB2, stimulates immune responses to the lung cancer antigen NY-ESO-1 and may also have potential utility in oesophageal, liver, gastric, prostate, ovarian and bladder cancers. Unlike classical adjuvants, Homspera® did not enhance the SCIB2 systemic immune response but did make it more effective at the tumour site. This could have profound implications for cancer vaccine therapy.


Scancell is currently conducting a Phase I clinical trial utilising its SCIB1 vaccine which is being developed for the treatment of melanoma. SCIB1 is a novel DNA vaccine which is also being developed using Scancell’s patented ImmunoBody® technology. ImmunoBody® vaccines generate the high-avidity T-cells that kill cancer cells... Scancell's Press Release - ImmuneRegen BioSciences' Press Release -

Lamellar Biomedical : First Orphan Drug Licence

June 16, 2011 - Provides 10-year Market Exclusivity for the treatment of Cystic Fibrosis - Glasgow biopharmaceutical firm, Lamellar Biomedical Ltd, launched four years ago to develop a new class of therapies for the prevention, treatment and control of severe respiratory disease, announced that their lead clinical candidate LMS-611 for the treatment of patients with cystic fibrosis has received Orphan Drug Designation from the European Commission. The designation follows a positive opinion from the Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) earlier this month.

“The designation of LMS-611 as an orphan drug by the European Medicines Agency underscores the importance of developing effective treatments for patients with cystic fibrosis,” said Dr Iain McDougall, Chief Business Officer of Lamellar Biomedical Ltd. “To date we have been extremely encouraged by LMS-611’s preclinical results, and we continue to believe we are developing a therapy which will prove to be both safe and effective with the potential to offer a brand new way of treating the disease when we enter clinical trials early next year.”

Drugs for rare diseases are called “orphans” because the small number of patients they would treat means they are often not developed by the pharmaceutical industry. Today’s designation will make it easier for Lamellar Biomedical Ltd to attract both investment and development partners and facilitate LMS-611’s entry into clinical use. Lamellar Biomedical Ltd and its partners will also have ten years to exclusively market the Drug in the European Union.

LMS-611 is developed from Lamellar’s proprietary inhaled LamellasomeTM delivery platform. The LamellasomeTM is based on the biological and biophysical resemblance to the natural lamellar bodies found in healthy lungs, and found to be absent in cystic fibrosis patients. By mimicking this missing body responsible for normal lung function, Lamellar Biomedical Ltd have already established an impressive package of preclinical data demonstrating significant potential as a mucus-altering treatment with the ability to fight and prevent infection... Lamellar Biomedical's Press Release -

Philips introduces HomeLox : only system that generates and stores liquid oxygen at home

June 21, 2011 - Philips introduces only system that generates and stores liquid oxygen at home; HomeLox helps increase freedom for patients and reduces costs for providers — Royal Philips Electronics (NYSE: PHG, AEX: PHI) introduced the HomeLox portable liquid oxygen system. The innovative system enables oxygen users to generate and store the liquid form of oxygen in the home setting. The HomeLox system offers users the long-lasting and lightweight characteristics of traditional liquid systems, while freeing them from difficulties of filling and dependence on deliveries associated with conventional systems.

Home oxygen is a critical, life-sustaining medical treatment prescribed to nearly 1.5 million Medicare patients annually who suffer from respiratory illnesses such as chronic obstructive pulmonary disease (COPD). (National Heart, Lung, and Blood Institute and American Thoracic Society)

HomeLox includes a liquid oxygen generation and storage unit that remains in the user’s home, and a lightweight and long-lasting portable device, GoLox. HomeLox generates liquid oxygen by converting room air into oxygen, and then chilling and converting it to liquid form using a proprietary refrigerant along with standard refrigeration technology found in industrial and household applications. The liquid oxygen is stored within the HomeLox unit until transferred to GoLox for portable use.



In addition to giving users the ability to generate and store liquid oxygen at home, the HomeLox system features a new hands-free clean filling process. To fill the GoLox portable device, the user simply places the unit on top of HomeLox, turns and locks the unit, and pulls the filling lever. The hands-free process helps reduce freezing, overfilling, and under filling.

For homecare providers, the new HomeLox liquid system reduces the cost and complexity of current systems commonly associated with delivered liquid oxygen systems which may include the purchase of specialized vehicles, testing equipment, and storage containers, as well as recurrent deliveries and filling-related service calls... Philips' Press Release -

Cephalon : Encouraging Results of Obatoclax in Extensive-Stage Small Cell Lung Cancer at ASCO Annual Meeting

June 7, 2011 – Cephalon presented new phase 2 data on an investigational compound, obatoclax, at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago, Ill. The data show that patients with extensive-stage small cell lung cancer receiving obatoclax in addition to standard chemotherapy demonstrated a trend toward improved overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) when compared to chemotherapy alone. This is the first presentation of solid tumor data for the Company following its acquisition of Gemin X in March 2011, which developed the drug. Obatoclax expands the Cephalon portfolio in oncology beyond hematologic malignancies.
“Small cell lung cancer is a deadly and fast-growing tumor type. Approximately 65 percent of patients with this type of lung cancer have extensive disease at presentation and new approaches to treatment are needed,” said Lesley Russell, Chief Medical Officer at Cephalon. “The results of this study, suggest that obatoclax could be a new treatment option for patients if these treatment effects are replicated in a larger phase 3 study.”... Cephalon's Press Release -

Insmed : ARIKACE® Demonstrates Sustained Benefit Through Six Cycles of Treatment for Cystic Fibrosis Patients With Pseudomonas Lung Infections

June 10, 2011 - Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, announced positive data through six treatment cycles (72 weeks total duration) of its Phase 2 clinical trial program for ARIKACE® (liposomal amikacin for inhalation) in cystic fibrosis (CF) patients with Pseudomonas lung infections. The data were presented at the 34th European Cystic Fibrosis Conference in Hamburg, Germany, by Predrag Minic, M.D., Professor of Pediatrics and Head of Pediatrics Pulmonology Department, Mother and Child Health Institute, Belgrade, Serbia, and co-lead investigator of the study.

The open label Phase 2 study was designed to evaluate ARIKACE over multiple treatment cycles in CF patients with Pseudomonas lung infections. The study enrolled 49 patients to receive ARIKACE 560 mg once daily for 28 days of therapy, followed by a 56-day off-treatment observation period. ARIKACE was administered using an optimized, investigational eFlow® Nebulizer System (PARI Pharma GmbH).

The data demonstrated that ARIKACE, delivered once-daily for 28 consecutive days, followed by 56 days off-treatment, for a total of six cycles, resulted in statistically significant improvement in lung function that was sustained over a 72 week period. Specifically, inhalation of 560 mg of ARIKACE produced a mean increase in pulmonary function (FEV1) of 11.7% at the end of the 28 day treatment period of the sixth cycle (p<0.0001).

During the course of the study, FEV1 improvement was also sustained at the end of 56 days off-treatment in each of cycles one through six, with an estimated relative increase in FEV1 of 5.7% (95% CI +3.0%, +8.5%; p=0.0001). Overall, ARIKACE was well-tolerated during all six cycles, with adverse events reported as consistent with those expected in a population of CF patients receiving inhaled medicines... Insmed's Press Release -

CytRx Increases Clinical Sites to 15 in Tamibarotene Phase 2b Clinical Trial in 1st Line Non-Small-Cell Lung Cancer to Expedite Patient Recruitment

Apr 20, 2011 - Clinical Trial Data Could Be Available in Second Half of 2012 - Development of Tamibarotene for Potential Multibillion Dollar Market is Major Priority for CytRx - CytRx Corporation (Nasdaq:CYTR), a biopharmaceutical company specializing in oncology, has expanded enrollment to 15 clinical sites in its Phase 2b clinical trial with tamibarotene in combination with chemotherapeutical agents for the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The large number of sites is expected to accelerate recruitment, and full enrollment of the approximately 140 patients is now anticipated in 12 months.
"We have opened enrollment in 15 clinical sites in the U.S. and Mexico for our tamibarotene clinical trial in 1st line NSCLC to expedite recruitment for an indication that could represent a blockbuster opportunity," said CytRx CEO Steven A. Kriegsman. "We expect these additional sites will accelerate enrollment, which means we could have data from this Phase 2b clinical trial by the end of 2012. What makes NSCLC so compelling is that it is responsible for more deaths than breast, prostate and ovarian cancers combined."
Daniel Levitt, MD, Ph.D., CytRx's Chief Medical Officer, said, "Tamibarotene is 10 times more potent than all trans retinoic acid (ATRA), while simultaneously showing properties that suggest it may lead to fewer adverse effects than ATRA. Recent published clinical data demonstrated that ATRA in combination with chemotherapeutical agents was statistically significant as a treatment for advanced NSCLC, which may open the door for tamibartotene based on its greater potency and lower side effect profile than ATRA."
In December 2010, CytRx initiated the Phase 2b clinical trial in patients with advanced NSCLC at a single clinical site. In this randomized clinical trial, patients with advanced NSCLC are treated with paclitaxel plus carboplatin and either tamibarotene or placebo. The primary objective of this trial is to determine the objective response rate (complete and partial responses) and progression-free survival. Secondarily, the trial will evaluate overall survival, quality-of-life and examine the pharmacokinetics of tamibarotene in this population, among other measures... CytRx's Press Release -

Promedior : Clinical Data for PRM-151 (rhPTX-2) in Idiopathic Pulmonary Fibrosis at American Thoracic Society 2011

May 16, 2011 - Data Highlights Safety and Biomarker Activity in Patients with IPF – Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, presented data from a clinical study of PRM-151 (recombinant human Pentraxin-2 (PTX-2)) at the 2011 American Thoracic Society International Conference (ATS 2011). The poster presentation entitled ”The Effects Of Recombinant Human Pentraxin-2, (PRM-151), On Circulating Fibrocytes In Idiopathic Pulmonary Fibrosis (IPF)” included clinical data from a completed Phase 1 study of PRM-151 that evaluated comprehensive safety endpoints and exploratory biomarker activity in healthy subjects and IPF patients. Across all study participants, PRM-151 was shown to be generally safe and well tolerated; and in a subset of study participants with IPF, PRM-151 showed activity against efficacy biomarkers through reductions in IPF-related blood fibrocytes levels and serum IL-6 levels.

"We are excited to present data from this clinical study, which underscore the potential of PRM-151 as a novel and powerful first-in-class agent to treat IPF, one of the most serious and difficult-to-treat fibrotic diseases... Promedior's Press Release -

Pfizer : The European Commission Approves Pfizer’s Revatio® (sildenafil) for the Treatment of Pulmonary Arterial Hypertension in Children

May 05, 2011 - New Indication Specifically for use in Pediatric Patients Based on Largest Placebo-Controlled Study Conducted in this Population - Pfizer Inc. announced that Revatio® (sildenafil citrate) has been approved by the European Commission for the treatment of pediatric patients aged 1 to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.

“Pulmonary arterial hypertension is a rare, devastating disease that can affect children," said Dr. Cara Cassino, vice president, Pfizer Medicines Development Group. “With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition. This approval is another example of our ongoing commitment to rare diseases.”

The approval was based on results of a dose-ranging phase 3 study that evaluated the efficacy and safety of Revatio versus placebo in 234 pediatric patients with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease. The primary endpoint was improvement from baseline in exercise capacity as assessed by change in peak volume of oxygen consumption (peak VO2) following 16 weeks of treatment. In children who were deemed developmentally unable to perform the test due to young age or the presence of other conditions, efficacy was assessed using secondary endpoints, including hemodynamics and change in WHO functional class... Pfizer's Press Release -

Almirall strengthens its respiratory franchise with a new generation of Chronic Obstructive Pulmonary Disease (COPD) treatment

April 11th, 2011 - New class of dual action long-acting Muscarinic Antagonist Beta-2 Agonist (MABA) has potential to change the paradigm of COPD treatment - Almirall is aiming at starting clinical studies during first half of 2012 - Almirall strengthens its position in the respiratory field with apositive development progress of another New Chemical Entity (NCE). LAS190792 is a new dual long-acting Muscarinic Antagonist β2 Agonist (MABA), which combines two bronchodilator mechanisms in a single molecule for the treatment of COPD. This new class of inhaled long-acting bronchodilators is expected to provide additional symptom relief in patients living with COPD, and to form the basis of so called triple combinations together with ICS (inhaled corticosteroids). The MABA franchise (MABA and MABA/ICS combination) offer the convenience of different mechanisms of action in one inhaler therapy, and is envisaged to become a future block buster in COPD.

“Almirall’s MABA (LAS190792) represents an exciting opportunity for the treatment of COPD and shows the strength of Almirall´s commitment to research in respiratory disease”, said Dr Bertil Lindmark, MD, PhD, and Chief Scientific Officer at Almirall.

MABA compounds offer the advantage over the two-molecule bronchodilator combinations (LABA/LAMA), in that MABA/ICS combinations can be developed with a reasonable size development programme.

In preclinical models, LAS190792 has shown to have a long duration of action and high anti-muscarinic activity combined with β2 agonism. The molecule shows very favourable drug properties and safety.

Almirall is planning to priorize the finalization of the pre-clinical phase, aiming at starting clinical studies during first half of 2012.

LAS190792 will be developed in the Genuair® inhaler, a novel, state-of-the-art, multi-dose dry powder inhaler... Almirall's Press Release -

Sanofi-aventis and Regeneron : Top-line Results from Phase III Study with aflibercept (VEGF Trap) in Second-Line Non-Small Cell Lung Cancer

March 10, 2011 - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) announced results from the Phase III VITAL trial evaluating the investigational agent aflibercept (VEGF Trap) for the second-line treatment of non-small cell lung cancer (NSCLC). The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet the pre-specified criteria for the primary endpoint of improvement in overall survival compared with a regimen of docetaxel plus placebo (HR=1.01, CI: 0.868 to 1.174). The addition of aflibercept to docetaxel demonstrated activity as measured by key secondary endpoints of the study: progression free survival (PFS) (HR=0.82, CI: 0.716 to 0.937) and an overall objective response rate (ORR) of 23.3% in the aflibercept arm compared to 8.9 percent in the placebo arm.


The treatment emergent adverse events (AEs) on the aflibercept arm with an incidence that was 10 percent greater than the control arm were stomatitis, weight decrease, hypertension, epistaxis and dysphonia. Grade 3 or 4 AEs that occurred at a frequency of at least 5 percent in patients who received aflibercept were fatigue, stomatitis, disease progression, hypertension, febrile neutropenia, dyspnea, neutropenia, and asthenia. AEs leading to treatment discontinuation occurred in 27.2 percent of patients in the aflibercept arm compared to 14.6 percent in the placebo arm. The types and frequencies of AEs reported in the aflibercept treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents... [PDF] Sanofi-aventis' Press Release - Regeneron Pharmaceuticals' Press Release -

Revalesio : research on the anti-inflammatory effects of RNS60 in Asthma

March 16, 2011 – Revalesio Corporation announced that research related to the use of RNS60, its novel anti-inflammatory, will be featured in two poster presentations at the Annual Meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in San Francisco on March 18-22.
AAAAI is the largest professional organization in the United States devoted to the specialty of allergy and immunology. It has nearly 6,500 members in the United States, Canada and 60 other countries.
Revalesio will present findings that demonstrate the novel anti-inflammatory activity of charge-stabilized nanostructures both in a preclinical model of allergic asthma and in cell culture experiments. These data suggest that Revalesio’s novel therapeutic RNS60 provides an opportunity for the development of a new generation of low-risk therapeutics for inflammatory pulmonary diseases.

In the preclinical model of asthma, RNS60 showed significant efficacy in the reduction of key inflammatory cytokines, including interleukin-6, interleukin-4, tumor necrosis factor-α (TNF-α), eotaxin and other cytokines known to be drivers of asthma. In addition to reducing inflammatory cytokines, RNS60 improved respiratory parameters compared to treatment with the inhaled corticosteroid budesonide... Revalesio's Press Release -

FDA informs Novartis of extension to US regulatory review period for QAB149, a novel once-daily bronchodilator for treatment of COPD

March 23, 2011 - Novartis announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for QAB149 (indacaterol) for the once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The FDA asked for a three-month extension in order to complete its review of the new drug application (NDA) for QAB149 by July 2011. In its notification, the FDA said it needed more time to examine the data submitted by Novartis in support of the application. The agency did not request additional data.

"This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical program resulting in a large amount of data to be reviewed," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "COPD is a life-threatening lung disease and a major cause of serious long-term disability[1]. We remain committed to bringing new therapies to patients who suffer from this condition."... Novartis' Press Release -

Stempeutics Research : DCGI nod to start Phase II clinical trial for four debilitating diseases

January 20 th, 2011 – Stempeutics Research a group company of Manipal Education & Medical Group announced that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by Manipal Group and Cipla...


[...]

...Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs in which the airways become narrowed. This leads to a restriction to the flow of air to and from the lungs causing shortness of breath. Currently the available treatment options are targeted at only symptomatic relief of COPD, which do not provide long term benefits to the patients. Mesenchymal stem cells are thought to stimulate the endogenous stem cells and help them to differentiate into alveolar epithelium, thus repairing the lung damage and improving pulmonary function. This study involves the evaluation of safety and efficacy of “Stempeucel” in COPD and finding the appropriate safe and effective dose for the disease... [PDF] Stempeutics Research's Press Release -

Forest Laboratories : FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD...

Mar 01, 2011 - Forest Announces FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD Associated with Chronic Bronchitis and a History of Exacerbations - Forest Laboratories, Inc. (NYSE: FRX) announced that Daliresp [TM] (roflumilast) was approved by the U.S. Food and Drug Administration (FDA) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The efficacy and safety of Daliresp was evaluated in eight clinical studies including 9,394 adult patients.

COPD is an under-diagnosed, progressive, irreversible lung disease. Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms - called an exacerbation - can last several weeks and often requires substantial medical intervention, including hospitalization.

Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved and is an oral tablet taken once daily. While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells. Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011... Forest Laboratories' Press Release -

Theratechnologies : new clinical program in muscle wasting in Chronic Obstructive Pulmonary Disease (COPD)

February 22, 2011 - Theratechnologies (TSX: TH) announced a new clinical program for muscle wasting in Chronic Obstructive Pulmonary Disease (COPD) using the Company's lead compound, tesamorelin, a human growth hormone releasing factor ("GRF") analogue.
Based on tesamorelin's anabolic properties, the Company has chosen to pursue the development of its lead compound in muscle wasting in patients with COPD as its second indication. COPD is characterized by progressive airflow obstruction due to chronic bronchitis or emphysema leading in certain cases to muscle wasting, a decrease of muscle mass and deterioration in functionality. Previously, Theratechnologies completed a Phase 2 trial in stable ambulatory COPD patients which demonstrated a statistically significant increase in lean body mass. The Company intends to commence a second Phase 2 clinical study in the second half of 2011 to test different dosages of tesamorelin with a new formulation... Theratechnologies' Press Release -

Helix BioPharma: European Clinical Trial Application For A Phase I/II Study Of Its Lung Cancer Drug Candidate L-DOS47

February 24, 2011 – Helix BioPharma Corp. (TSX, NYSE Amex, FSE: “HBP”), a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer,announced that it has filed a clinical trial application (“CTA”) with the Central Register of Clinical Trials at the Polish Ministry of Health seeking approval to perform its planned Phase I/II clinical safety, tolerability and preliminary efficacy study of its lung cancer drug candidate L-DOS47.
L-DOS47 is Helix’s first therapeutic immunoconjugate drug candidate under development based upon the Company’s novel DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic, non-small cell lung cancer (“NSCLC”)... [PDF] Helix BioPharma's Press Release -