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 -