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 -