Clear Catheter Systems : US FDA Clearance for the PleuraFlow Active Tube Clearance System

December 13, 2010 — Clear Catheter Systems, Inc, a Bend, Oregon-based medical device company, announced that it has received US Food and Drug Administration clearance for its innovative PleuraFlow™ Active Tube Clearance System. This is a device that can be widely deployed in the post operative management of patients requiring heart and lung surgery. The company has approval to market the device in Europe and Canada, and this regulatory approval clears the way to market the product in the United States for patients recovering from cardiothoracic surgery.
When chest tubes become clogged blood can build up around the heart and lungs which can lead to complications and even death. The PleuraFlow System employs a proprietary active tube clearance system which allows the medical professional to maintain a functioning chest tube in the post operative period... [PDF] Clear Catheter Systems' Press Release -

APP Pharmaceuticals : Approval and Launch of Topotecan for Injection

Nov 30, 2010 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

Topotecan for Injection is therapeutically equivalent to the reference-listed drug Hycamtin(R), which is currently marketed by the innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales of Hycamtin(R), in 2009 were $157.1 million.

Topotecanfor Injection is indicated for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is also indicated for use in combination therapy with Cisplatin for stage IV-B, and for recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. APP will market Topotecanfor Injection in 4 mg single dose vials; the product is bar-coded and preservative-free... APP Pharmaceuticals' Press Release -

IsoRay : Its Revolutionary Internal Radiation Therapy for Lung Cancers is Focus of National Study

October 13, 2010 -… IsoRay, Inc. (Amex: ISR) announced the initiation of a multi-institutional study of Cesium-131 brachytherapy seeds (internal radiation therapy) for use in Non Small Cell Lung Cancers (NSCLC). A number of institutions and physicians will be working to collect scientific data to further the use of Cesium-131 internal radiation therapy in conjunction with surgery for NSCLC. The study expands participation in the application of the breakthrough internal radiation treatment. It allows doctors to aggressively treat lung cancer using a single procedure upon tumor removal that is demonstrating its impact as a new vital weapon in the war on cancer.
Lung cancer continues to be the leading cause of cancer deaths worldwide. There are two main types of lung cancer - Small Cell Lung Cancer and Non Small Cell Lung Cancer. Non Small Cell Lung Cancer is the most common type of lung cancer. Some 8 to 9 out of 10 cases of all lung cancer cases are non small cell type. This year alone, an estimated 225,000 cases of lung cancer will be diagnosed of which some 80% will be Non Small Cell Lung Cancer... [PDF] IsoRay's Press Release -

Amakem : COPD drug development program

November 15, 2010 - Amakem receives 1.28M€ government funding for COPD drug development program - Localized Drug Action platform addresses side effects – Amakem announces that it has been awarded 1.28M€ by the Flemish government agency for Innovation by Science and Technology (IWT) to support its Rho kinase (ROCK) inhibitor-based drug development program for chronic obstructive pulmonary disease (COPD).
Amakem was founded early this year by Dirk Leysen (CSO) and Olivier Defert (director external R&D), both former Devgen researchers. Jack Elands (CEO), who joined shortly thereafter, comments: “COPD is a serious disease for which no cure exists. So-called kinase inhibitors hold great promise, but many have failed in clinical trials because of their limited therapeutic window. To address this fundamental problem with such kinase based drugs we developed our „Localized Drug Action‟ platform."
Amakem focuses on making drugs safer by limiting or avoiding systemic exposure, thereby reducing side effects caused in non target organs... [PDF] Amakem's Press Release -

China Medical Technologies : SFDA Approval for its First Self-Developed PCR-based EGFR Assay for Lung Cancer Targeted Drugs

Nov. 10, 2010 - China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, announced that it has received approval for its real-time PCR-based Epidermal Growth Factor Receptor ("EGFR") Assay (the "EGFR PCR Assay") for the use of lung cancer targeted drugs from the State Food and Drug Administration of China (the "SFDA").

The EGFR PCR Assay is used for the detection of the 28 most common somatic mutations in the EGFR gene of patients with non-small cell lung cancer ("NSCLC") and provides a qualitative assessment of mutation status to determine the use of lung cancer targeted drugs for patients.

With its own internal research and development efforts, the Company has successfully developed its first PCR-based assay related to companion diagnostic tests for personalized medicines for cancer patients. The Company's EGFR PCR Assay is the first PCR-based EGFR assay for the use of lung cancer targeted drugs approved by the SFDA... China Medical Technologies' Press Release -

Synergenz BioScience Awarded Therapeutic Discovery Project Grant

Nov. 2, 2010 – Synergenz BioScience, Inc., a leader in predictive risk stratification for smoking-related lung cancer, was awarded a research grant under the Federal Government’s Qualifying Therapeutic Discovery Project (QTDP) program.

The $94,836 grant will assist Synergenz’s ongoing clinical utility trials for Respiragene™, a genetic-based test for lung cancer predisposition. Respiragene™ identifies the subset of individuals most likely to develop lung cancer from their smoking habit -- before disease strikes -- allowing doctors to improve preventative care for a cancer usually diagnosed too late to save their patients... Synergenz's Press Release -

Sequella : International Support for Phase 2 Clinical Trials of SQ109, its Lead Antitubercular Drug Candidate

October 18th, 2010 - Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa.
The Phase 2 studies, which will support international regulatory submissions, will be performed by the Pan African Consortium for Evaluation of Antituberculosis Antibiotics (PanACEA). The studies will be funded by a €12 million grant by the European and Developing Countries Clinical Trials Partnership (EDCTP) and a €3 million commitment by Sequella for in-kind and corporate funding. The multi-year clinical program will be directed by Professor Michael Hoelscher, Department of Infectious Diseases and Tropical Medicine, University Hospital of LMU, in conjunction with Sequella.
“TB is a global health problem that will only be solved by international cooperation and focus on improvement in patient care,” said Dr. Carol A. Nacy, CEO of Sequella. “We are excited by the opportunity to work with EDCTP, the LMU, and the very talented group of TB experts in PanACEA to further the clinical development of SQ109.”... [PDF] Sequella's Press Release -

ImmuneWorks : National Clinical Trial for New Idiopathic Pulmonary Fibrosis (IPF) Treatment

October 19, 2010 - Biotechnology Firm ImmuneWorks Begins National Clinical Trial for New Idiopathic Pulmonary Fibrosis (IPF) Treatment – ImmuneWorks, Inc. announced the initiation of its Phase I clinical trial in patients suffering from idiopathic pulmonary fibrosis (IPF), a serious lung disease. The clinical trial will move the biotech company one step closer to commercialization of its lead IPF treatment compound.

Eight leading academic research universities will conduct the IPF clinical trial: Indiana University, Medical University of South Carolina, Ohio State University, University of Alabama-Birmingham, University of Chicago, University of Louisville, University of Michigan and University of Vermont.

“We are pleased to move forward into clinical investigation of our purified Type V collagen solution in patients suffering from IPF... ImmuneWorks' Press Release -

Radient Pharmaceuticals And Provista Life Sciences : New Blood Test For Lung Cancer

October 13, 2010 – Provista Life Sciences and Radient Pharmaceuticals Corporation (RPC) (NYSE AMEX: RPC) announced the validation study results of a blood test for early detection of lung cancer and Provista’s plans to broadly introduce this new test to market.
The study completed the requisite analyses and data evaluation needed to validate Provista’s test, based on Radient Pharmaceutical Corporation’s antigens for fibrinogen degradation products (FDP), successfully detects lung cancer with a high degree of accuracy. The study included men and women between 2076 years of age. The data generated in this final study proved consistent with previous findings and produced positive clinical performance marks of 87% sensitivity; 95% specificity; and an ROC Accuracy of 0.97. By industry standards the study proved very successful and will serve as the cornerstone to Provista’s efforts to introduce a new lung cancer detection assay branded LC Sentinel™ to market.

Provista intends to introduce LC Sentinel™ as a CLIA Laboratory Developed Test (LDT) for use in highrisk
lung cancer patient populations in the U.S. by the end of the fourth quarter 2010 through its standard clinical channels that include physicians, medical clinics and hospitals. The company expects to seek FDA registration for LC Sentinel™ in 2011... [PDF] Radient Pharmaceuticals' Press Release -

Linde RSS expands REMEO® offering to include pediatric respiratory services

September 30, 2010 -- Linde RSS has signed an agreement to provide respiratory care services to pediatric residents at St. Margaret’s Center in Albany, New York. The agreement constitutes an extension of the Linde REMEO® respiratory service, which has traditionally been offered to adults. The agreement comes on the heels of St. Margaret’s decision to expand its current facility so it could offer more comprehensive pediatric respiratory services.
Linde RSS is an affiliate of Linde North America, which is a member of The Linde Group, a world-leading healthcare, gases and engineering company. St. Margaret’s, which started as a home for abandoned children 127 years ago, now provides services to residents with unique physical, mental and emotional needs throughout New York State and beyond. With the expansion, St. Margaret’s is increasing its capacity to 94 residents, which ranges from newborns to young adults.

Linde will provide a turn-key respiratory solution that includes therapists, gases and equipment that are included in the company’s REMEO® program for innovative care of mechanically ventilated patients. St. Margaret’s pediatric nurses will work side-by-side with the Linde respiratory team to provide highly specialized care, 24-hours a day.

“Linde impressed us with their clinical focus and comprehensive respiratory therapy offering... Linde's Press Release -

Elevation Pharmaceuticals : $30 Million in Series A Financing, funds for clinical development of aerosol therapies in COPD

January 21, 2010 – Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced the closing of a $30 million tranched Series A financing. Investors participating include Canaan Partners, TPG Growth, Care Capital, and Mesa Verde Venture Partners. Concurrent with this financing, Elevation has added to its board of directors Brent Ahrens, General Partner at Canaan, Heather Preston, Managing Director at TPG Biotech, and Jan Leschly, Chairman and Partner at Care Capital. Existing directors include co-founders Cam Garner, Chairman, and Bill Gerhart, President and Chief Executive Officer.

“We have a great opportunity to significantly improve the standard of care for those patients most in need of better aerosol therapies, and we are very fortunate to have attracted a syndicate of accomplished and experienced investors to help realize this vision... Elevation Pharmaceuticals' Press Release -

ProtAffin AG : manufacturing contract for PA401 with CMC Biologics A/S

27th July, 2010 : ProtAffin AG, a biotechnology company developing a novel class of biopharmaceutical products that act by targeting cell-surface glycan structures, announced it has signed a manufacturing contract with CMC Biologics’ Danish operations, located in Copenhagen, Denmark for manufacture of its lead product PA401 for the treatment of chronic obstructive pulmonary disease (COPD). The contract will cover manufacture and supply of PA401 for preclinical development and early clinical development in COPD and related respiratory indications. PA401 is a glycan-binding decoy protein based on human chemokine IL-8 (CXCL8), which has shown potent anti-inflammatory activity in both chronic and acute preclinical models of lung inflammation. A composition of matter patent covering PA401 has been granted in the USA and the EU.

ProtAffin’s novel class of biopharmaceutical products are first-in-class engineered versions of human proteins which bind to cell surface glycans (sugars) to affect their biological activity. Specific cell surface glycans underlie inflammatory processes in several diseases including COPD, and represent a rich and relatively under-investigated class of potential drug targets for pharmaceutical and biotechnology companies. ProtAffin’s approach is entirely innovative and opens up glycans as druggable targets through the use of its CellJammer® discovery technology... [PDF] ProtAffin's Press Release -

Stromedix : FDA Orphan Drug Designation for STX-100 for the Treatment of Idiopathic Pulmonary Fibrosis

August 31, 2010 - Stromedix, Inc., a biotechnology company focused on innovative therapies for fibrosis and fibrotic organ failure, announced that its lead clinical candidate STX-100 has been granted orphan drug status by the U.S. Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis (IPF), a debilitating and almost uniformly fatal disease in which patients experience progressive difficulty breathing due to fibrosis (scarring) of the lung. There are currently no FDA approved treatments for IPF. Stromedix is planning to initiate a Phase 2 clinical trial in IPF patients in 2011.
"STX-100 targets a key pathway in the initiation and progression of pulmonary fibrosis... [PDF] Stromedix's Press Release -

EarlySense : EverOn® Contact-Free, Patient Supervision System Detects Patient Deterioration with Advanced Respiratory Analysis

June 14, 2010 – EarlySense, developer of the EverOn contact-free, patient supervision system for hospital and post acute care, announced the results of a multicenter study conducted at several hospitals in the United States and Israel. The data were recently made public by Drs. Eyal Zimlichman, Martine Szyper-Kravitz, Howard Amital, and Yehuda
Shoenfeld at the American Thoracic Society Conference in New Orleans in a presentation titled, Recognizing Specific Respiratory Patterns Preceding in Hospital Clinical Deterioration, a Multicenter Study. The data will also be presented at the ILSI-Biomed 2010 conference in Tel Aviv.
The objective of the study was to evaluate the correlation between the different parameters measured by the EverOn system and the detection of patient deterioration in hospitals. More than 200 patients were monitored on the medical/surgical floors of three medical centers with the EverOn system. The results show that by combining the measurements of respiratory rate, heart rate and a new respiratory pattern alert called “Double Respiration Pattern”, patients who are likely to deteriorate are effectively identified. A risk factor of 12.2 was shown for major patient deteriorations, i.e. there was a dramatic 12.2 times greater chance of a major deterioration in patients where the system alerted versus patients where it didn’t.
“The double respiration pattern identified in the clinical trial utilizing the EverOn technology is an exciting development that may help identify patient deteriorations early on. It is well known that early identification has a very significant potential impact on improved outcomes in
hospitalized patients. This multicenter study showed that the combination of respiratory rate, heart rate and double respiration pattern alerts provide a detection rate of 90% of major patient deteriorations. We look forward to continuing to study this promising technology,”... [PDF] EarlySense's Press Release -

Biotie : positive top-line data from clinical study with its third generation oral PDE4 inhibitor - ELB353 is well tolerated...

26 April 2010 - Biotie reports positive top-line data from clinical study with its third generation oral PDE4 inhibitor - ELB353 is well tolerated and shows clear pharmacological activity - Biotie reported that it has successfully completed a Phase I trial with its orally administered phosphodiesterase 4 (PDE4) inhibitor ELB353, intended for the treatment of chronic obstructive pulmonary disease (COPD).
The study evaluated the safety, tolerability, pharmacokinetic characteristics and pharmacodynamic effects of repeated oral doses of ELB353 in 48 healthy male volunteers. ELB353 was generally well tolerated, and no serious or severe adverse events were reported in any of the study subjects. The pharmacokinetic characteristics of ELB353 demonstrated its suitability for a once daily dosing regimen. Robust and statistically highly significant biomarker responses confirmed the pharmacological activity of well tolerated doses of ELB353 in man.
"We are very pleased with the properties of ELB353 seen in this study"... Biotie's Press Release -

Ligand Acquired Milestone and Royalty Interest in AstraZeneca IL-9 Program for Asthma

May 21, 2010 - Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that it has purchased from the Genaera Liquidating Trust certain intellectual property and interests in future milestones and royalties for MEDI-528, an IL-9 antibody program under development by AstraZeneca's subsidiary, MedImmune. MEDI-528 is currently in a 320-patient Phase II study for moderate-to-severe asthma.


Ligand paid $2.75 million to the Genaera Liquidating Trust in connection with the purchase. This opportunity arose from initial diligence and work conducted by Biotechnology Value Fund, L.P. (BVF). As part of this transaction and a result of BVF's contributions, Ligand entered into a separate agreement with BVF and certain of its affiliates, whereby BVF and Ligand will share the purchase price and any proceeds from the deal equally. Accordingly, BVF has paid Ligand $1.375 million... Ligand Pharmaceuticals' Press Release -

Radiometer : ABL800 FLEX reduces risk of misdiagnosis of patients with pleural effusions

16 April 2010 - Radiometer’s ABL800 FLEX blood gas analyzer now offers a dedicated mode for measuring pH in pleural fluid (the fluid between lungs and chest wall) on patients with pleural effusion.

Measurement of pH in pleural fluid on the ABL800 FLEX – as opposed to commonly used pH meters – is validated and done through a dedicated sample mode, reducing the potentially fatal risk of a diagnostic misclassification of the effusion and under-treatment of the condition.

pH in pleural fluid best performed on blood gas analyzers
Pleural effusion is often present in patients suffering from infections such as pneumonia and cancers, but also on patients suffering from heart failure.

The American College of Chest Physicians (ACCP) consensus panel on the medical and surgical management of parapneumonic effusions recommends that pleural fluid pH is the preferred pleural fluid chemistry test for pleural effusion and should be measured on a blood gas analyzer... Radiometer's Press Release -

SonarMed : FDA clearance for respiratory product

May 11, 2010 - Indianapolis medical device firm receives FDA clearance for respiratory product – SonarMed™, a developer and manufacturer of critical care respiratory monitoring technologies, announced that it has received Food and Drug Administration clearance for its patented SonarMed™ Airway Monitoring System (AMS), which monitors breathing tubes for patients requiring ventilators.
The SonarMed AMS uses acoustic reflection technology to provide precise, real-time monitoring of breathing tubes. The system may be used to assist clinicians in preventing and detecting conditions that can harm the patient, such as movement of the breathing tube, which can result in ventilation failure or lung damage, and obstruction of the breathing tube, which can deprive the patient of needed oxygen. Compared with the conventional standards of care and available patient information, having this type of adjunctive information about the breathing tube provides clinicians with a more immediate and complete picture of the patient’s respiratory support status... [PDF] SonarMed's Press Release -

Pulmonx : $32 Million for Launch of Emphysema Products

February 22, 2010 - Emerging Interventional Pulmonology Leader Commences Rollout of Breakthrough New Products – Pulmonx, an emerging leader in interventional pulmonology, announced that it has concluded an agreement for a new round of equity financing from an investment syndicate led by two new investors. The company also announced that it plans to use this capital to support the international commercial launch of its Zephyr® Endobronchial Valve (EBV), and its recently approved Chartis® Pulmonary Assessment System. Both products are CE marked and cleared for sale in Europe and other major international markets. The company expects that this round of financing will fund the expansion of its commercial operations through to positive cash flow and profitability... [PDF] Pulmonx's Press Release -

Nycomed’s novel anti-inflammatory therapy Daxas® (roflumilast) : marketing authorisation in the European Union for patients with COPD

06.07.2010 :

• Anti-inflammatory treatment aimed at patients with severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis
• First new class of treatment for COPD in more than a decade
• Improves lung function and reduces exacerbations, when added to bronchodilator treatment

Nycomed announced that the European Commission has granted marketing authorisation for Daxas® (roflumilast) in the European Union. Daxas® is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD, a progressive, life-threatening lung disease.

Daxas® is indicated for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. Daxas, an oral tablet taken once a day, is the first drug in a new class and is expected to be launched soon in the first European countries, starting with Germany and the UK... Nycomed's Press Release -

Kitware and Lung Cancer Alliance : First Publicly Available Lung Cancer Database Created Through Patient Data Donations

June 8, 2010 - Kitware and Lung Cancer Alliance announce the release of the first group of lung cancer patient records now publicly available for download at GiveAScan.

This open image archive represents the successful completion of a pilot project to determine the feasibility of a patient donated database to accelerate medical research. This initial nine patient database includes over 1 GB of radiological imaging studies including Computed Tomography (CT) scans, volunteered by patients to accelerate lung cancer research including screening, computer aided detection and diagnosis, and the development of quantitative methods for drug therapy assessment.

Patient imaging records and additional related medical information reside in the public database, but remain anonymous.

"Lung cancer research relies heavily on the ability to extract statistically meaningful insights and observations from real-world clinical data,"... Kitware's Press Release -

FDA Approves Merck's DULERA® Inhalation Aerosol for the Treatment of Asthma in Patients 12 Years of Age and Older

June 24, 2010 – Merck announced that the U.S. Food and Drug Administration (FDA) has approved DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. DULERA is not indicated for the relief of acute bronchospasm. DULERA combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate). The approval of DULERA is based, in part, on Phase III studies that evaluated the safety and efficacy of DULERA in patients 12 years of age and older with persistent asthma.

"Despite the advances made in the treatment of asthma in recent years, many patients may still not be well-controlled on their current therapies,”... Merck's Press Release -

Palatin Technologies : Positive Preclinical Data with PL-3994 for Asthma Indications

June 21, 2010 – Palatin Technologies, Inc. (NYSE Amex: PTN) announced results of preclinical studies in respiratory tissue with PL-3994. In rat, guinea pig and human tissues, PL-3994 produced potent relaxation of isolated airway smooth muscle, indicating that PL-3994 may be a potent bronchodilator in humans.

PL-3994 is a proprietary peptide mimetic that binds and activates natriuretic peptide receptor A, a guanylate cyclase. Naturally occurring natriuretic peptides have been evaluated for bronchodilator activity in previous clinical studies with asthmatics. Despite positive outcomes, no commercial products have been developed in part, Palatin believes, because of the very short half-life of those molecules. In earlier Phase 1 clinical studies conducted by Palatin, PL-3994 has been shown to have a significantly longer half-life than endogenous natriuretic peptides, with biological effects attributable to relaxation of smooth muscle seen for up to eight hours following single administrations in man... Palatin Technologies' Press Release -

Merck Serono Resumes Stimuvax Clinical Program in Lung Cancer

June 17, 2010 - FDA lifts clinical hold on START clinical trial – Merck Serono, a division of Merck KGaA (Darmstadt, Germany), and its U.S. affiliate, EMD Serono, Inc. announced that they are resuming their Stimuvax® (BLP25 liposome vaccine*) clinical program in patients with non-small cell lung cancer (NSCLC), which includes the Phase III studies, STARTa and INSPIREb. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.
“Merck Serono remains highly committed to the development of BLP25 liposome vaccine and the well-being of the patients. We believe this therapeutic cancer vaccine has the potential to be a valuable addition to the future range of therapies for oncologists and their patients,”... [PDF] Merck Serono's Press Release -

Zargis to Launch FDA-Cleared Lung Sounds Analysis Technology from Stethographics, Inc.

June 11, 2010 - Zargis Medical Corp., a majority-owned subsidiary of Speedus Corp. (Nasdaq: SPDE), announced that it has entered into an agreement with Boston-based Stethographics, Inc. providing an exclusive license to patented, FDA-cleared Stethographics lung sounds analysis technology that automatically identifies clinically significant respiratory sounds. Zargis plans to incorporate the technology into its existing telemedicine and computer-aided auscultation platform in order to deliver these new diagnostic support tools to medical professionals.

Stethographics is a leading developer of automated, noninvasive sound analysis products designed to help medical professionals identify and interpret clinically significant lung sounds. The company was founded in 1998 by Dr. Raymond Murphy, a Professor of Medicine at Tufts University School of Medicine who also spent 25 years as an assistant professor at the Harvard School of Public Health... Zargis Medical's Press Release -

Rational Therapeutics : Metastatic NSCLC Survival Doubled Using Functional Profiling to Select Drug Treatments

Jun 03, 2010 - Study to be Presented at ASCO Demonstrates How Ex-Vivo Assay-Directed Therapy Changes Natural History of Non Small Cell Lung Cancer (NSCLC) - A team of investigators at Rational Therapeutics, Inc. and the Malcolm Todd Cancer Institute (Long Beach, Calif.) has reported that functional profiling using ex-vivo analysis of programmed cell death (EVA/PCD) can be used to prescribe treatment regimens that double the response rate and survival in patients with Stage IV non-small cell lung cancer (NSCLC). The findings of their phase II clinical trial will be presented on Sunday, June 6th at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

Functional profiling provides a real-time window on how human tumors will respond to therapy. By capturing cells within their natural microenvironment, it approximates human biology in the laboratory. NSCLC - the leading cause of cancer death in the US, with little change in survival for decades - offers an ideal target for this approach... Rational Therapeutics' Press Release -

Clovis Oncology & Avila Therapeutics : $209 Million Partnership for the Worldwide Development and Commercialization of EGFR Mutant-Selective Inhibitor

May 25, 2010 -

• Avila’s oral, small molecule program targets cancer-causing mutant forms of the EGF receptor (EGFR)
• Innovative treatment approach for non-small cell lung cancer (NSCLC) patients with disease resistant to current therapy
• Potency against key disease mutation, T790M, while minimizing activity against the wild-type (normal) EGFR to increase therapeutic index and avoid side effects of current standard of care
• Clovis to lead accelerated clinical development plan including companion diagnostic to prospectively identify T790M-positive NSCLC patients -

Clovis Oncology, Inc., a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents, and Avila Therapeutics, Inc., a biotechnology company designing targeted covalent drugs, announced an agreement for the development and commercialization of Avila’s epidermal growth factor receptor (EGFR) mutant-selective inhibitor (EMSI) program, currently in pre-clinical development for the treatment of non-small cell lung cancer (NSCLC).

The EMSI program targets the T790M mutant form of the EGFR associated with clinical resistance to Tarceva® (erlotinib) and Iressa® (gefitinib)i, as well as targeting the initial activating EGFR mutations, including L858R and exon 19 deletions. It does so while also sparing the wild-type (normal) EGFR and may thus treat refractory NSCLC while minimizing dose-limiting side effects. Because the program targets both the sensitive activating mutations as well as the primary resistance mechanism, T790M, it has the potential to treat both first- and second-line NSCLC patients with EGFR mutations, for whom there is great unmet medical need... [PDF] Clovis Oncology's Press Release - [PDF] Avila Therapeutics' Press Release -

OxySure : GSA Contract

June 3, 2010 – OxySure® Systems, Inc., a manufacturer and pioneer of innovative emergency/short duration respiratory solutions, announced the Company was awarded a multi-year contract by the General Services Administration (GSA) to supply its products to all branches of the US Federal Government. The Company’s Federal Supply Schedule Contract number V797P-4153b is unrestricted, or a 100% set-aside contract for small business, and has an initial term ending November 14, 2013. Thereafter, the contract may be renewed for up to 3 additional 5-year terms. Federal buyers will be able to purchase OxySure products immediately, either directly from OxySure or via GSA Advantage!®, the US government’s online shopping and ordering system.
GSA awards contracts to responsible companies offering commercial items, at fair and reasonable prices. OxySure is a trusted emergency oxygen solution and has been approved and validated by third parties such as the FDA, UT Austin, Southwest Research Institute, and North Texas Enterprise Center for Medical Technology, and has hundreds of documented cases of saved lives... [PDF] OxySure Systems' Press Release -

Revotar Biopharmaceuticals : Phase II Clinical Trial in COPD Patients with inhaled Bimosiamose

June 10, 2010 – Revotar Biopharmaceuticals AG announced the start of a Phase II study to evaluate the safety and efficacy of inhaled Bimosiamose, a pan-selectin antagonist, for the treatment of patients with chronic obstructive pulmonary disease (COPD).
The trial is designed as a double-blind, placebo controlled, randomized, cross-over study comprising up to 60 non-smoking patients with moderate to severe COPD (GOLD II-III). Each subject will receive nebulized Bimosiamose solution or vehicle for 28 consecutive days twice daily in two subsequent periods according to a randomization plan and separated by a wash-out phase (cross-over). Co-alternative primary endpoints will be the difference of neutrophils counts and interleukin-8 levels in induced sputum following Bimosiamose and Placebo; secondary variables cover lung function parameters as well as cellular and non-cellular biomarkers. The study is conducted at 10 centers in Germany... [PDF] Revotar Biopharmaceuticals' Press Release -

Sandoz : acquisition of Oriel Therapeutics, strengthening potential for global leadership in respiratory

June 3, 2010– Sandoz announced that it has completed its acquisition of Oriel Therapeutics, a privately held US pharmaceuticals company, for an undisclosed sum.

• Closure gives Sandoz rights to several promising development projects, as well as to novel FreePath™ drug delivery system and Solis™ multi-dose dry powder inhaler
• Regulatory approvals, if achieved, would broaden access to affordable, high-quality respiratory medicines and reinforce Sandoz’s position as a leader in differentiated generics...

[...]

...Oriel focuses on developing respiratory products with known pathways as generic alternatives to patented drugs for asthma and chronic obstructive pulmonary disease (COPD). Regulatory approvals of these medicines, if achieved, would enable Sandoz to increase access to affordable, high-quality therapeutic alternatives for these increasingly prevalent diseases... Sandoz's Press Release -

Oncimmune : Studies Demonstrate Early Stage Detection and Economic Benefits of a Blood-Based Test for Lung Cancer

June 1, 2010 - Oncimmune EarlyCDT-Lung™ First in a Menu of Tests to Aid in the Detection of Most Solid Tumor Cancers – Oncimmune LLC, maker of EarlyCDT-Lung™, a simple blood test that aids physicians in risk assessment and the early detection of lung cancer, announced validation study results demonstrating the diagnostic and economic benefits of a standardized and reproducible autoantibody laboratory test (AABT) that may significantly improve the prognosis for lung cancer patients. Currently, lung cancer is responsible for more deaths than breast, prostate, colon, liver, kidney and melanoma cancers combined.
Studies were completed with 573 patients known to have lung cancer who were matched against normal patients (no lung cancer) for the same age, sex and smoking history. The test, which is regulated under CLIA, has 40% sensitivity and 90% specificity. This means that the test detects 40% of lung cancers, including early stage disease (Stages I and II), and the overall accuracy of the test is greater than 88%. This performance compares favorably with other well known tests such as mammography in younger women or in the case of lung cancer, where EarlyCDT-Lung performance is at least twice as good as CT. Study findings suggest that the autoantibody test is not influenced by sex, ethnicity, geographic location of patients or the presence of benign autoimmune diseases. Previous studies have shown that autoantibodies can be detected up to five years before tumors can be seen in routine diagnostic imaging procedures such as CT.
Oncimmune researchers also set forth the modeled cost-effectiveness of EarlyCDT-Lung as an aid to lung cancer diagnosis, with an estimated $6,000 potential cost savings for every QALY (quality-adjusted life year) saved. Study results are being introduced in multiple poster presentations June 6, 2010, at the annual meeting of the American Society of Clinical Oncology... [PDF] Oncimmune's Press Release -

Verona Pharma : AGM Statement

3 June 2010 -...“In the twelve months since the last AGM Verona Pharma has seen significant progress in its drug development programmes.
“Highlights

• Successfully completed Phase I/IIa clinical trial of RPL554 and licensing discussions are progressing.
• Conducting further studies for RPL554 to add value to the licensing package and strategically prepare the drug for further clinical trials.
• VRP700 - regulatory documents have been finalised and awaiting submission to the appropriate regulatory and ethical authorities.
• NAIPs – continuing to evaluate novel compounds from collaborative partners, to determine clinical potential as anti-inflammatory drug candidates.
• Maintaining low burn rate, currently with approx. £3m in cash.

“Since successfully completing its Phase I/IIa clinical proof of concept trial of RPL554, leading to the issue of the quality assured report by the Centre for Human Drug Research ("CHDR"), discussions with potential licensing partners have been progressing. While discussions continue, we are adding value to the RPL554 licensing package by conducting further studies. Treatments for asthma and COPD are commonly delivered using a dry powder inhaler and we have conducted experimental studies to confirm that RPL554 can be administered in this form. In addition we are carrying out further clinical studies on the safety of RPL554 at higher doses, the duration of action with respect to bronchodilation, and the extent of its anti-inflammatory action. These additional studies are expected to increase the Company’s Intellectual Property package concerning RPL554; in turn strengthening our position during licensing discussions and increasing RPL554’s value... [PDF] Verona Pharma's Press Release -

Deep Breeze : FDA CLEARS UNIQUE NON-INVASIVE, RADIATION-FREE PULMONARY IMAGING SYSTEM FOR AIDING IN DIAGNOSIS

May 30, 2010 — Deep Breeze™, the innovative company that has developed the Vibration Response Imaging (VRI™) technology, announced that the U.S. Food and Drug Administration (FDA) granted 510K marketing clearance for the VRIXP™, previously cleared for recording and monitoring lung sounds, as an Aid in Diagnosis and patient management when interpreted by physicians with general medical training and experience.
“The new FDA approval is the result of close to 10 years of research and development and clinical work, enabling adding to the visual presentation of VRI images, objective quantitative measures, amongst which is the automatic detection of adventitious lung sounds such as crackles and wheezes. This presents the physicians with a complementary tool to help in diagnosing respiratory disorders.”... [PDF] Deep Breeze's Press Release -

Centocor Ortho Biotech Acquires RespiVert Strengthens Pulmonary Focus

June 1, 2010 - Acquisition Bolsters Pulmonary Portfolio and Capabilities, Accessing Promising Pipeline of First-in-Class Compounds and Renowned Team of Respiratory Scientists – Centocor Ortho Biotech Inc. announced that it has acquired RespiVert Ltd., a privately held drug discovery company focused on developing small-molecule, inhaled therapies for the treatment of pulmonary diseases. The company’s lead compounds, RV-568 and RV-1088, narrow spectrum kinase inhibitors with a unique profile of anti-inflammatory activities, are progressing into clinical development as potential first-in-class treatments for moderate to severe asthma, Chronic Obstructive Pulmonary Disease (COPD) and Cystic Fibrosis (CF).


The clinical development of RV-568 and RV-1088 will be led by RespiVert in collaboration with scientists at Centocor Research and Development, Inc. The company is not disclosing financial terms... Centocor Ortho Biotech [JNJ] -

Breathe Technologies Secures $23 Million in Series C Financing

May 18, 2010 - John Miclot elected chairman; FDA clearance received - Breathe Technologies, Inc., a manufacturer of innovative technology solutions for people with respiratory conditions, including chronic obstructive pulmonary disease and sleep apnea, announced it has secured $23 million in Series C financing. The financing was led by DAG Ventures and included Kleiner Perkins Caufield & Byers (KPCB), Delphi Ventures, Synergy Partners International and Johnson & Johnson Development Corporation. Additionally, industry leader John L. Miclot joined as chairman of the board, and the company received FDA 510(k) clearance for its wearable ventilation system... [PDF] Breathe Technologies' Press Release -

Funxional Therapeutics : ...10 million Euros... to fund the initial Phase II clinical studies of FX125L in inflammation

26 May 2010 - Funxional Therapeutics Ltd (Funxional Therapeutics) announced the completion of a Series B financing round in which it raised a total of EUR 10 million (US$ 12.5 million). Ventech participated as a new investor in this round, together with existing investors Index Ventures and Novo A/S.
The capital raised enables Funxional Therapeutics to further progress the development of novel anti-inflammatory therapies that belong to a new class referred to as Broad Spectrum Chemokine Inhibitors (BSCIs). The Company’s lead drug candidate, FX125L, an orally available small molecule, is ready for Phase II studies in different inflammatory conditions. The preclinical development of back-up compounds to FX125L will also be advanced in parallel...

[...]

...About BSCIs
BSCIs are a new class of anti-inflammatory compounds with an entirely novel mechanism of action that involves the selective interaction with a well-characterised receptor (which is distinct from the chemokine receptor) and results in a potent inhibition of inflammatory cell migration. The compounds are anticipated to have broad applications in major inflammatory diseases such as asthma / COPD, RA, psoriasis and IBD... [PDF] Funxional Therapeutics' Press Release -

Cardiocom : Telehealth Platform with New Pulse Oximeter

May 14 - Cardiocom announced the release of its new pulse oximeter. Cardiocom’s internally developed pulse oximeter offers better integration with its telehealth platform. Cardiocom designs and manufactures telehealth communication devices and vital sign peripherals including: blood pressure system, weight scale, and now offers its new pulse oximeter. The Company’s vertical integration provides the highest quality telehealth system that is easy to use for patients and clinicians. Cardiocom’s new pulse oximeter is specifically suited for the home telehealth environment and was registered with the FDA in late 2009...Cardiocom's Press Release -

Cytokinetics : Non-Clinical Data from Its Smooth Muscle Contractility Program at the American Thoracic Society’s 2010 International Conference

May 18, 2010 - Inhibitors of Smooth Muscle Myosin May Offer a Novel Therapeutic Approach to the Treatment of Chronic Obstructive Pulmonary Disease and Asthma - Cytokinetics, Incorporated (Nasdaq: CYTK) announced that a poster summarizing non-clinical data regarding its smooth muscle contractility program was presented at the American Thoracic Society’s 2010 International Conference which was held May 14-19, 2010 at the Ernest N. Morial Convention Center in New Orleans, LA... Cytokinetics' Press Release -

Galapagos and Roche : COPD alliance

11 May 2010 – Galapagos NV (Euronext: GLPG) announced that it has expanded its global multi-year strategic alliance with Roche (SIX: RO, ROG; OTCQX:RHHBY) to develop potential new therapies in COPD (chronic obstructive pulmonary disease). The partners have increased the number of antibody targets in the alliance. In addition, these targets can now also be used as starting points for molecules consisting of nucleic acids and/or amino acids. As such, the scope of molecules subject to this alliance could potentially include also peptides, siRNA and other nucleic acids.


Galapagos and Roche started their strategic alliance in COPD in January 2010. Galapagos is applying its target discovery platform to discover novel COPD targets and is responsible for the discovery and development of new small molecule candidate drugs against these targets. Roche has an exclusive option to license each small molecule program after either clinical candidate selection or completion of Phase I clinical trials. In addition, Roche has an exclusive option to license the COPD targets for the discovery and development of antibodies against these targets. Upon exercise of each option, Roche will be responsible for the further (pre)clinical development and commercialization. Galapagos received a research access payment of €6 million from Roche upon signature of the alliance. The alliance expansion announced today has the potential to increase the total value of milestone payments Galapagos receives under this agreement by €150 million... Galapagos' Press Release -

Cellceutix : Important New Data on Kevetrin(TM) in Resistant Lung Cancer Model Show Dose Response; No Tumor Cell Resistance With Second Cycle

04.21.2010 - Cellceutix Corporation (OTCBB: CTIX), a bio-pharmaceutical company that develops small molecules to treat cancer and inflammatory disease, announced that it presented a poster session at the American Association for Cancer Research (AACR) 101st Annual Meeting in Washington, D.C. This poster session included data on Kevetrin that have not previously been made public. These data showed that the efficacy of Kevetrin in a mouse model of drug resistant lung cancer increases with increasing dose. These data also show that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance. In addition to the new lung cancer data, the poster includes data showing a positive effect for Kevetrin in animal models of drug-resistant colon and breast cancer cell lines... Cellceutix's Press Release -

Nabriva Therapeutics : successful Phase I clinical trial for BC-3781

12.04.2010 - Nabriva Therapeutics announced that it has successfully completed a series of Phase I clinical trials of its pleuromutilin antibiotic, BC-3781. BC-3781 is being developed for intravenous and oral treatment of skin and skin structure infections (SSSI) and community-acquired pneumonia (CAP). Data from some of these Phase I trials is being presented at the 20th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna as posters on Sunday, 11th April and in an oral presentation on Monday, 12th April.

The results of the clinical trials which began in July 2009 demonstrate that BC-3781 was safe and well tolerated up to the maximum doses tested. BC-3781 exhibits predictable pharmacokinetics in humans and the plasma levels achieved show that it has therapeutic potential for the treatment of skin and lung infections caused by bacteria. Nabriva will now progress BC-3781 into Phase II studies... Nabriva Therapeutics' Press Release -

NexBio : Clinical Trial of DAS181 (Fludase®*) in Asthmatics Initiated at the National Institutes of Health

May, 3, 2010 – NexBio, Inc. announced the initiation of a trial of DAS181 (Fludase®) in patients with the respiratory conditions asthma and bronchiectasis, being conducted by researchers with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This trial will examine the effects of DAS181 in subjects with well-controlled or stable pulmonary disease. Patients with pre-existing pulmonary illnesses such as these are at high risk for complications of influenza and have limited antiviral drug options, due both to side effects and possible drug resistance. More information about the study may be found at www.clinicaltrials.gov.
DAS181 is a novel broad-spectrum, host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI) and has shown preclinical activity against numerous strains of influenza and parainfluenza virus. DAS181 blocks entry of these viruses into cells of the respiratory tract. In November 2009, NexBio announced data at the annual American College of Allergy, Asthma, and Immunology meeting demonstrating anti-asthma activity of DAS181 in multiple animal models of asthma... [PDF] NexBio's Press Release -