Delphi Medical Systems : New Delphi Portable Oxygen Concentrator Designed to Provide Exceptional Portability to Patients

May 6, 2008 - Delphi Medical Systems, a subsidiary of Delphi Corp., is introducing its new portable oxygen concentrator, the Central Air, which can help patients gain increased freedom and independence by providing exceptional durability in a lightweight package. Delphi also announced that it has entered an exclusive agreement with evo Medical Solutions to distribute the device in North America for millions of adults who require supplemental oxygen treatment after being diagnosed with chronic obstructive pulmonary disease (COPD). Currently, the device has 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Delphi's design delivers concentrated oxygen in a compact size and convenient format, and boasts the smallest footprint and package size in its class. Measuring under a foot high and weighing less than 10 pounds, the unit allows premium portability so that patients can participate in more mobile lifestyles... Delphi Medical Systems' Press Release -

ImClone : Significant Data on ERBITUX (cetuximab) and ImClone Pipeline to Be Presented at American Society of Clinical Oncology 2008 Annual Meeting

May 16, 2008 - ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that significant scientific data on ERBITUX(R) (cetuximab) will be presented at the American Society of Clinical Oncology (ASCO) 2008 Annual Meeting taking place May 30 through June 3, 2008 in Chicago...
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Non-Small Cell Lung Cancer

• A phase II study of cetuximab (C225) in combination with chemoradiation (CRT) in patients (PTS) with stage III A/B NSCLC: A report of the 2-year and median survival (MS) for the RTOG 0324 trial. G.R. Blumenschein (#7516)
• A phase II study of pemetrexed, carboplatin and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small cell lung cancer: CALGB 30407 - - Early evaluation of feasibility and toxicity. R. Govindan (#7518)... ImClone Systems' Press Release -
  

Olympus Medical Systems and Spiration : Agreement to Market and Distribute Minimally Invasive Pulmonary Device in 43 European Countries

May 19, 2008 – Olympus Medical Systems Corp. and Spiration, Inc. announced today that the companies have signed a definitive agreement granting Olympus exclusive marketing and distribution rights in Europe for Spiration's IBV® Valve System. Olympus will launch the product in select European countries from Autumn 2008. The IBV Valve System is a minimally invasive treatment that has diverse applications for both acute and chronic conditions of the lung.

In Europe, the system has received market clearance through CE Mark for diseased and damaged lung, a broad indication that includes the treatment of emphysema and the resolution of prolonged air leaks, a complication that can occur following lung surgery... Olympus Medical Systems' Press Release - [PDF] Spiration's Press Release -

Pfizer : New Data in Lung Cancer to Be Presented at ASCO

May 16, 2008 - Pfizer announced that study results across several difficult-to-treat cancers will be presented at the 44^th American Society of Clinical Oncology (ASCO) annual meeting in Chicago from May 30 to June 3, 2008. Pfizer will hold two briefings for journalists on June 1 and investors on June 2.

Researchers will present the latest data from the breadth of Pfizer’s oncology portfolio, focused in four areas of discovery: anti-angiogenesis, signal transduction, immuno-oncology and cytotoxics/potentiators...

...Non-small Cell Lung Cancer (NSCLC)

• Phase 2 data evaluating the activity of the anti-IGF-1R antibody CP-751,871 in combination with paclitaxel and carboplatin in NSCLC will be presented by Dr. Daniel Karp, MD Anderson Cancer Center on Monday, June 2.
• Phase 1 clinical trial data exploring the safety and preliminary activity of PF-299804, an irreversible pan-HER inhibitor will be presented by Dr. Pasi A. Janne, Dana Farber Cancer Center on Monday, June 2.
• Characterization of NSCLC patients responding to anti-IGF-1R therapy will be presented by Dr. Antonio Gualberto, Pfizer Global Research and Development on Sunday, June 1... Pfizer's Press Release -
  

Array BioPharma and AstraZeneca : New Phase 2 Development Plans for the Investigational Anti-Cancer Drug AZD6244 (ARRY-886)

May 15, 2008 - Array BioPharma Inc. (NASDAQ: ARRY) and AstraZeneca (NYSE: AZN) announced plans for two additional randomized Phase 2 trials for AZD6244 (ARRY-886). The trials, which will begin during the second half of 2008, will test AZD6244 in combination with a cytotoxic chemotherapeutic agent; one trial will be in melanoma patients and the other in non small cell lung cancer patients. These plans are based upon AZD6244's activity as a single agent in previous monotherapy Phase 2 trials and on data from multiple preclinical studies.
The data from these earlier clinical trials will be presented at the forthcoming American Society of Clinical Oncology Annual Meeting... Array BioPharma's Press Release -

Guided Therapeutics, Inc. and Konica Minolta : to Expand Cancer Detection Technology

May 06, 2008 - Guided Therapeutics, Inc. (GT) (Pink Sheets: SPRX) announced that it has entered into a collaborative option to license and no shop agreement with Konica Minolta Opto, Inc. (KMOT) of Tokyo.
Under terms of the agreement, KMOT will have a defined period of time to evaluate certain applications of GT’s technology, including the potential adaptation of its LightTouch™ non-invasive cervical cancer detection technology to lung and biliary cancer.
KMOT also will purchase prototype equipment and single use disposables... [PDF] Guided Therapeutics' Press Release -

Arriva Pharmaceuticals Granted Fusion Protein Patent

May 21, 2008 - Intellectual Property Provides Strong Position for Development of Therapy for Asthma- Arriva Pharmaceuticals, a biopharmaceutical company focused on developing anti-inflammatory therapies, announced today that it had been granted a patent in the U.S. related to a fusion protein with potential applications for treating respiratory diseases. The patent (United States Patent 7,247,704) covers compositions of matter and uses of Aeriva™, a fusion protein that combines Secretory Leukocyte Protease Inhibitor (SLPI) and recombinant alpha 1-antitrypsin (rAAT)... [PDF] Arriva Pharmaceuticals' Press Release -

EPIX Pharmaceuticals : Phase 2a Data at American Thoracic Society Meeting

May 15, 2008 - EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX), a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform, announced that Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX, is scheduled to present an oral presentation entitled "Selective Serotonin-2B Receptor Antagonist PRX-08066 Improves Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease" at the International Conference of the American Thoracic Society in Toronto on Wednesday, May 21, 2008 at 2:50 p.m. ET.

EPIX previously announced the results of a Phase 2a clinical trial of PRX-08066 in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD)... EPIX Pharmaceuticals' Press Release -

Osiris Therapeutics : Phase II Clinical Trial Evaluating Prochymal for Chronic Obstructive Pulmonary Disease

May 21, 2008 - Osiris Therapeutics, Inc. (NASDAQ:OSIR) announced the treatment of the first patients in a new Phase II clinical trial evaluating Prochymal, a mesenchymal stem cell (MSC) therapy, for moderate to severe Chronic Obstructive Pulmonary Disease (COPD). This trial marks the sixth indication for which Prochymal has been advanced into Phase II or later-stage clinical trials.

COPD, a form of lung disease characterized by limitation or obstruction of airflow in the airway, encompasses both emphysema and chronic bronchitis. COPD is the fourth leading cause of death in the U.S. with an estimated 12 million Americans diagnosed with the disease. COPD has no known cure, thus current therapeutic intervention is aimed at providing relief of symptoms. Preclinical and clinical data suggest that Prochymal’s unique mechanism of action may provide a first-in-class treatment option with the ability to reverse the underlying disease... [PDF] Osiris Therapeutics' Press Release -

3M : First FDA-Cleared Respirators for General Public Use in Public Health Medical Emergencies Now Available

May 16, 2008 - -Consumers concerned about an influenza outbreak can breathe a little easier: 3M has just released two new NIOSH N95 respirators for use by the general public in public health medical emergencies.
These two respirators—3M™ Particulate Respirator 8612F and 3M™ Particulate Respirator 8670F—are unique because they are the first to receive clearance by the U.S. Food & Drug Administration (FDA) to reduce exposure to airborne germs during a public health medical emergency such as an influenza pandemic. The FDA outlined a special clearance process for N95 respirators used by the general public in public health medical emergencies in order to provide reasonable assurance of their safety and effectiveness... 3M's Press Release -

VGX Pharmaceuticals : multi-year production agreement with the United Kingdom Cystic Fibrosis Gene Therapy Consortium

May 12, 2008 – VGX Pharmaceuticals (VGX) announced that the Company has signed a multi-year supply agreement to provide plasmid DNA to support the ongoing toxicology and clinical trials of the United Kingdom Cystic Fibrosis Gene Therapy Consortium comprising over 80 scientists and clinicians in Edinburgh, London and Oxford dedicated to the search for effective gene therapy to the lungs of those with Cystic Fibrosis. Under the terms of the agreement, VGX will provide multiple batches of a CFTR product to support clinical studies planned to run through 2010. If all options are exercised, several hundred grams of plasmid DNA will be provided, making this agreement one of the largest contracts for non-viral gene therapy products ever undertaken... VGX Pharmaceuticals' Press Release -

Nektar : Patent Covering Pulmonary Targeted Antibiotics

May 7, 2008 - Nektar Therapeutics (Nasdaq: NKTR) announced that the U.S. Patent and Trademark Office has issued Patent No. 7,368,102, which covers compositions and methods for creating and delivering Tobramycin Inhalation Powder (TIP) and other aminoglycoside antibiotics delivered via Nektar's proprietary Dry Powder Inhaled Technology. This patent extends through the year 2022.

TIP is being co-developed by Nektar and Novartis and is currently in Phase 3 development for the prevention and treatment of Pseudomonas aeruginosa pneumonia. Cystic fibrosis patients are susceptible to chronic infection by P. aeruginosa, which is responsible for high rates of illness and death in this patient population. Nektar's Dry Powder Inhaled Technology has the capability to administer high local lung concentrations of TIP that may provide significant benefits to patients suffering from this debilitating disease... Nektar Therapeutics' Press Release -

Oscient & Menarini : Regulatory Filing for FACTIVE Tablets Submitted in Europe

May 7, 2008 - Oscient Pharmaceuticals Corporation's (Nasdaq: OSCI) commercialization partner for FACTIVE(R) (gemifloxacin mesylate) tablets, Menarini Group, a leading European pharmaceutical company based in Italy, has submitted a regulatory filing seeking approval of FACTIVE in Europe. Menarini, with broad sales and marketing coverage throughout Europe and expertise in research and clinical development, has the fourth largest pharmaceutical sales force in Europe and is second largest in terms of calls to primary care physicians...

... Menarini is seeking approval of FACTIVE for the treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis. The regulatory review time in Europe is approximately 12 months.... Oscient Pharmaceuticals' Press Release -

GE HEALTHCARE & Merck : GLOBAL MOLECULAR DIAGNOSTIC AGREEMENT TO ADVANCE RESPIRATORY DRUG DEVELOPMENT

May 05, 2008 - - GE Healthcare, a subsidiary of the General Electric Company (NYSE:GE) announced today that it has signed a non-exclusive agreement with Merck & Co., Inc. to share technology on imaging of the lungs that may help to advance respiratory treatment development.

Under terms of the agreement, Merck will be granted access to Spin Signal TechnologyTM (SST) utilizing hyperpolarized Xenon 129 gas, a molecular imaging agent that is under investigation by GE Healthcare to provide high speed, quantitative imaging of the lung using Magnetic Resonance Imaging (MRI). GE Healthcare originally licensed this technology from Princeton University... GE Healthcare's Press Release -