Cortex : Enrollment in Opiate Induced Respiratory Depression Clinical Trial in Germany

March 31, 2008 — Cortex Pharmaceuticals, Inc. (AMEX: COR), was notified by the German regulatory agency which approves the use of narcotic drugs that it can proceed with the trial which will use alfentanil, an opiate analgesic. With this approval the enrollment of subjects into the dose response study evaluating the ability of CX717 to prevent respiratory depression caused by opiate analgesics has begun. The study is a placebo controlled, double blinded, cross-over design with three doses of CX717compared to placebo. Depending on the pace of subjects being enrolled, Cortex at this point believes that top-line data will be available from this study by the end of June, 2008... Cortex Pharmaceuticals' Press Release -

Actelion and Nippon Shinyaku : pulmonary arterial hypertension (PAH) compound collaboration

February 29, 2008 - Nippon Shinyaku Co., Ltd. and Actelion Ltd announced today that the two companies have signed a binding letter of intent regarding Nippon Shinyaku's novel PGI 2 receptor agonist NS-304 for the treatment of pulmonary arterial hypertension (PAH) *1).NS-304, originally discovered and synthesized by Nippon Shinyaku, is an orally available long acting prostaglandin I 2 receptor agonist *2) , w hich stim ulates PGI 2 receptor in blood vessels and exerts vasodilating effects. NS-304 has major potential as a novel treatment of PAH. Nippon Shinyaku has recently completed phase I evaluation in the United Kingdom. A phase II program in PAH patients was initiated in Europe at the end of 2007... Nippon Shinyaku's Press Release - Actelion's Press Release -

Angeion : Medical Graphics Platinum Elite Series Plethysmograph for Pulmonary Function Testing

March 17, 2008 ─ Angeion Corporation (NASDAQ: ANGN) introduced the Medical Graphics Platinum Elite™ Series plethysmograph. Based on the award winning Elite Series design, the Platinum Elite offers advanced functionality, ease of operation, precision, reliability and improved patient comfort. Designed for use in hospitals and doctors’ offices, the Platinum Elite is used to measure pulmonary function in the diagnosis of airway diseases such as chronic obstructive pulmoary disease (COPD), asthma, emphysema, allergies and other lung conditions... Angeion's Press Release -

Ceragenix Pharmaceuticals : CeraShield(TM) Coated Endotracheal Tubes Provide up to 21 Days of Protection against Bacterial Colonization in Preclinical

Mar 18, 2008 -- Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP) (the "Company"), a biopharmaceutical and medical device company focused on infectious disease and dermatology, announced that preclinical testing of the Company's CeraShield(TM) coated endotracheal tubes and C.R. Bard's recently FDA cleared Agento(TM) tube has shown that Cerashield(TM) coated endotracheal tubes were able to provide a 7 fold increase in the duration of antimicrobial protection compared to the recently cleared silver coated Agento(TM) tube from C.R. Bard. The CeraShield(TM) coated endotracheal tube was able prevent bacterial colonization and biofilm development for 21 days while C.R. Bard's Agento(TM) endotracheal tubes lost their ability to prevent bacterial colonization and biofilm development after 3 days when challenged with daily high inocula (10E6) of Pseudomonas aeruginosa. Bacterial growth on endotracheal tubes is a key component in the pathogenesis of Ventilator Associated Pneumonia ("VAP") which afflicts an estimated 250,000 patients each year and is associated with high morbidity ( 36,000 deaths) and added hospital costs of $4 billion in the U.S. alone... Ceragenix's Press Release -

NIR Diagnostics : agreement with a European medical device distributor for HemoNIR

March 17, 2008 - NIR Diagnostics Inc. (TSX Venture: NID), an innovator in the development of handheld healthcare diagnostic devices, announced that it has signed a regional distribution agreement for its portable CO-oximeter device, HemoNIR™, with a European based medical device distributor company. The multi-year agreement stipulates that the Distributor must meet a defined set of sales performance criteria. NIR Diagnostics is currently not disclosing the name of the Distributor pending the completion of negotiations with North American medical device companies also interested in distribution rights to HemoNIR™... NIR Diagnostics' press Release -

Third Wave’s InPlex CF Molecular Test : FDA Clearance

March 14, 2008—Third Wave Technologies Inc. (NASDAQ: TWTI) announced that the company has received clearance from the U.S. Food and Drug Administration of its InPlex™ CF Molecular Test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. The InPlex™ CF Molecular Test delivers the accuracy of Third Wave’s Invader® chemistry in an easy-to-use microfluidic card developed in collaboration with 3M Co. In studies submitted to the FDA as part of the company’s clearance application, the InPlex™ CF Molecular Test achieved 100% agreement on cystic-fibrosis positive samples and 99.96% overall agreement when compared to DNA sequencing, the standard for genotype determination... Third Wave Technologies' Press Release -

Celgene : Amrubicin Receives FDA Orphan Drug Designation for the Treatment of Small Cell Lung Cancer

March 25, 2008--Celgene Corporation (NASDAQ: CELG) announced that Amrubicin has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer.

FDA's Orphan Drug Act was designed to encourage the development of products that demonstrate promise for the diagnosis, prevention and/or treatment of life-threatening or very serious conditions that are rare and affect 200,000 persons or less in the United States. Orphan drug designation provides an important economic incentive for the development of new products in the cancer field... Celgene's Press Release -

Lorus : initiation of IND-enabling toxicology studies for its lead small molecule drug, LOR-253

March 25, 2008 - Lorus Therapeutics Inc. ('Lorus'), a biopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, announced the start of GLP toxicology studies for its lead anticancer small molecule drug LOR-253...
...LOR-253 (formerly known as LT-253) is a proprietary small molecule compound discovered at Lorus and optimized for its anticancer properties. In preclinical studies, LOR-253 has shown selective and potent antitumor activity in a variety of human cancers, including colon cancer and non-small cell lung cancer, and has an excellent therapeutic window due to its low toxicity. The mode of action of LOR-253 involves the downregulation of cyclin D1, an important regulator of cell cycle progression and cell proliferation. Alterations in the cyclin D1 regulatory pathway have been linked to the development of cancer... [PDF] Lorus Therapeutics' Press Release -

Poniard Pharmaceuticals : Commercial Manufacturing Agreement With W. C. Heraeus GmbH for Picoplatin

March 26, 2008 - Poniard Pharmaceuticals, Inc. (Nasdaq: PARD), a biopharmaceutical company focused on oncology, announced an agreement with W. C. Heraeus GmbH for the commercial manufacture and supply of picoplatin active pharmaceutical ingredient (API). Poniard is investigating picoplatin, the Company's lead product candidate, in four clinical trials, including the ongoing pivotal Phase 3 trial in small cell lung cancer, and is developing picoplatin as a potential new platform product for the treatment of solid tumors... Poniard's Press Rlease -

OXiGENE : Phase II NSCLC Trial of ZYBRESTAT(TM) in Combination with Bevacizumab and Chemotherapy

Mar 26, 2008 - OXiGENE, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced that the company has begun dosing patients in a randomized, double-blinded, controlled Phase II study of its potential first-in-class vascular disrupting agent (VDA), ZYBRESTAT(TM) (fosbretabulin), in combination with the anti-angiogenic drug, bevacizumab, and the chemotherapeutic agents carboplatin and paclitaxel as first-line therapy for patients with Stage IIIb/IV non-small cell lung cancer (NSCLC).

The multi-center study is being conducted in the US and India and is expected to enroll approximately 60 patients at 14 sites. Half of the patients will be administered intravenous ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel, and half will receive the standard first-line regimen of a combination of bevacizumab, carboplatin and paclitaxel. The primary outcome of the trial will be a comparison of safety and progression-free survival between the two treatment arms. The study design also includes analysis of tumor response rate as measured by RECIST criteria. The anticipated duration of the study is 24 months, and the company expects to announce top-line data in the second half of 2009... OXiGENE's Press Release -

Discovery Labs and Chrysalis Technologies : about Collaboration for Future Development of Aerosolized Drug Device Products

April 2, 2008 - Discovery Laboratories, Inc. (NasdaqGM:DSCO ) and Chrysalis Technologies (a division of Philip Morris USA, Inc.) have been collaborating to develop combination drug device products that unite Discovery Labs' precision-engineered synthetic surfactant with Chrysalis' novel capillary aerosolization technology to address respiratory diseases. To date, the collaboration has focused on developing a prototype device for use in Discovery Labs' upcoming Phase 2 clinical trials for Aerosurf, aerosolized Surfactant Replacement Therapy (SRT) for premature infants. Under the modified collaboration, Discovery Labs will assume full responsibility, effective July 1, 2008, to further develop the capillary aerosolization technology into devices for potential clinical and commercial application... [PDF] Discovery Labs' Press Release -

MediciNova : Phase II Clinical Trial of MN-221 in Status Asthmaticus Patients

March 31, 2008 - MediciNova, Inc., a biopharmaceutical company that is publicly traded on the Nasdaq Global Market (Nasdaq:MNOV) and the Hercules Market of the Osaka Securities Exchange (Code Number:4875), announced the initiation of a Phase II clinical trial, by holding the Investigator's Meeting, to determine the safety and efficacy of MN-221 in patients with severe, acute exacerbations of asthma.

This randomized, modified single-blind, placebo-controlled, dose escalation Phase II clinical trial will involve approximately 36 patients in three dose cohorts at eight emergency department clinical sites in the U.S. and Puerto Rico. Each patient will receive MN-221 or placebo administered through a continuous infusion in addition to the standardized care treatment for an acute exacerbation of asthma. Once the patient has received the initial standardized care treatment regimen (consistent with the National Asthma Education and Prevention Program guidelines), the patient will be assessed for response to that treatment... MediciNova 's Press Release -

Vertex : Positive Results for VX-770, an Oral Investigational Agent That Targets a Defective Protein Responsible for Cystic Fibrosis

Mar 27, 2008 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced results from a planned interim analysis of an ongoing Phase 2a clinical trial in patients who carry the G551D mutation in the gene that causes cystic fibrosis (CF). The interim analysis showed that dosing of VX-770, an investigational CF potentiator, as an oral agent for 14 days resulted in improved lung function and in improved function of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) protein as measured by changes in sweat chloride levels and changes in nasal potential difference (NPD). Results from the interim analysis support the hypothesis that improving chloride ion transport in CF patients may correlate to improvements in lung function and provide benefit to patients. Results are being shared with regulatory authorities and leading CF investigators in order to identify the most rapid path forward for the compound.

"While these are early data, it is unprecedented for an investigational oral compound for the treatment of CF to have such a marked effect on multiple measures of CF disease activity. We saw an average improvement in lung function of 10 percent in patients receiving the highest dose, compared to no observed improvement in patients who received placebo," said Frank Accurso, M.D., Director of the Cystic Fibrosis Center and Professor of Pediatrics at the University of Colorado School of Medicine in Denver. "These data suggest that VX-770 may be able to improve lung function by targeting an underlying defect in CFTR that causes the disease. In patients with CF, inadequately functioning or missing CFTR is believed to result in abnormal balance of fluid and salt in the airways. These are early clinical data in a subset of patients with malfunctioning CFTR, but an important proof-of-concept, and we look forward to evaluating the longer-term safety and efficacy of VX-770 in additional studies."... Vertex's Press Release -

Philips : completion of Respironics acquisition

March 17, 2008 - — Royal Philips Electronics (NYSE:PHG, AEX:PHI) (“Philips”) and Respironics, Inc. (NASDAQ:RESP) (“Respironics”) announced that Philips has completed the acquisition of Respironics through the merger of its indirect wholly owned subsidiary with and into Respironics. As a result of the merger, Respironics has become an indirect wholly owned subsidiary of Philips... Philips' Press Release -