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 -