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 -