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 -