Cellceutix : Important New Data on Kevetrin(TM) in Resistant Lung Cancer Model Show Dose Response; No Tumor Cell Resistance With Second Cycle

04.21.2010 - Cellceutix Corporation (OTCBB: CTIX), a bio-pharmaceutical company that develops small molecules to treat cancer and inflammatory disease, announced that it presented a poster session at the American Association for Cancer Research (AACR) 101st Annual Meeting in Washington, D.C. This poster session included data on Kevetrin that have not previously been made public. These data showed that the efficacy of Kevetrin in a mouse model of drug resistant lung cancer increases with increasing dose. These data also show that the administration of a second cycle of therapy with Kevetrin in the same animal model continues to delay tumor growth without the development of resistance. In addition to the new lung cancer data, the poster includes data showing a positive effect for Kevetrin in animal models of drug-resistant colon and breast cancer cell lines... Cellceutix's Press Release -

Nabriva Therapeutics : successful Phase I clinical trial for BC-3781

12.04.2010 - Nabriva Therapeutics announced that it has successfully completed a series of Phase I clinical trials of its pleuromutilin antibiotic, BC-3781. BC-3781 is being developed for intravenous and oral treatment of skin and skin structure infections (SSSI) and community-acquired pneumonia (CAP). Data from some of these Phase I trials is being presented at the 20th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Vienna as posters on Sunday, 11th April and in an oral presentation on Monday, 12th April.

The results of the clinical trials which began in July 2009 demonstrate that BC-3781 was safe and well tolerated up to the maximum doses tested. BC-3781 exhibits predictable pharmacokinetics in humans and the plasma levels achieved show that it has therapeutic potential for the treatment of skin and lung infections caused by bacteria. Nabriva will now progress BC-3781 into Phase II studies... Nabriva Therapeutics' Press Release -

NexBio : Clinical Trial of DAS181 (Fludase®*) in Asthmatics Initiated at the National Institutes of Health

May, 3, 2010 – NexBio, Inc. announced the initiation of a trial of DAS181 (Fludase®) in patients with the respiratory conditions asthma and bronchiectasis, being conducted by researchers with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This trial will examine the effects of DAS181 in subjects with well-controlled or stable pulmonary disease. Patients with pre-existing pulmonary illnesses such as these are at high risk for complications of influenza and have limited antiviral drug options, due both to side effects and possible drug resistance. More information about the study may be found at www.clinicaltrials.gov.
DAS181 is a novel broad-spectrum, host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI) and has shown preclinical activity against numerous strains of influenza and parainfluenza virus. DAS181 blocks entry of these viruses into cells of the respiratory tract. In November 2009, NexBio announced data at the annual American College of Allergy, Asthma, and Immunology meeting demonstrating anti-asthma activity of DAS181 in multiple animal models of asthma... [PDF] NexBio's Press Release -

Mylan Pharmaceuticals : Approval for Generic Version of Zyban(R)

May 4, 2010 - Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-release Tablets USP (SR), 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban(R)... Mylan's Press Release -

BioMarin Pharmaceutical : Positive Results for Phase I/II Trial for BMN 110 for MPS IVA

April 29, 2010 - GALNS Demonstrates Benefits in Endurance and Pulmonary Function Endpoints - BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced positive results for the Phase I/II trial for BMN 110 or N-acetylgalactosamine 6-sulfatase (GALNS), intended for the treatment of the lysosomal storage disorder Mucopolysaccharidosis Type IVA (MPS IVA), or Morquio A Syndrome. The company expects to initiate a pivotal Phase III trial in the fourth quarter of 2010.

Highlights from the Phase I/II study:

- Endurance improvements with GALNS were consistent with, and in some cases, better than those observed in pivotal studies of approved enzyme replacement therapies.
- Clinically meaningful improvements in two measures of endurance (6-minute walk distance and 3-minute stair climb) were achieved at both 24 weeks and 36 weeks as compared to baseline. (See Table 1 below).
- Clinically meaningful improvements in two measures of pulmonary function (forced vital capacity and maximum voluntary ventilation) were achieved at 36 weeks as compared to baseline... BioMarin Pharmaceutical's Press Release -

deCODE genetics "deCODEing Smoking: New Genetic Factors Behind Nicotine Dependence and Lung Cancer"

April 25, 2010 – Cigarette smoking is a major cause of illness and death worldwide. But it is a complex behavior, and how much people smoke, how hard they find it to quit, and the impact of long-term smoking on health varies greatly among individuals. A substantial portion of this variability is genetic. Two years ago, deCODE discovered the first common, single-letter variation (SNP) in the sequence of the human genome, on chromosome 15q25, associated with nicotine addiction and risk of lung cancer. Today, deCODE scientists and academic colleagues from 23 institutions in a dozen countries build on this work with the discovery of common SNPs on chromosomes 8p11 and 19q13 that among smokers increase the number of cigarettes smoked per day (CPD), a measure of nicotine addiction, and increase risk of lung cancer... deCODE genetics' Press Release -

Biodesix : VeriStrat® Outcomes Data in Lung Cancer to be Presented at IASLC/ESMO 2nd European Lung Cancer Conference

April 19, 2010 – Biodesix announced that results from the VeriStrat biomarker analysis of a Phase III clinical trial will be presented by David Carbone, M.D., Ph.D., Professor of Medicine and Cancer Biology, Vanderbilt University School of Medicine, on Friday, April 30th at the 2nd European Lung Cancer Conference to be held in Geneva. The purpose of the study was to evaluate the ability of VeriStrat to predict patient outcomes to epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy in previously treated non-small cell lung cancer (NSCLC) patients.

VeriStrat, a blood-based proteomic test, is currently used by physicians to help them guide treatment for patients with previously treated advanced NSCLC... Biodesix's Press Release -

Johnson & Johnson Pharmaceutical Research and Development : FDA Approves New Drug Application for PANCREAZE

April 13,2010 - Pancreatic Enzyme Therapy Approved by FDA to Treat Exocrine Pancreatic Insufficiency - Johnson & Johnson Pharmaceutical Research and Development (J&JPRD) announced that the U.S. Food and Drug Administration (FDA) has approved a new drug application (NDA) for PANCREAZE™ (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. Exocrine pancreatic insufficiency is the inability to properly digest and absorb food due to a lack of enzymes made by the pancreas that are important in the digestion of fats, proteins, and sugars... Johnson & Johnson's Press Release -

GeNO LLC : Investigational New Drug Application for Nitric Oxide Delivery System

March 9, 2010 – GeNO LLC a privately held, advanced development-stage technology company, announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its stand-alone gas cylinder Nitrosyl TM Delivery Platform (NDP). The initial indication to be studied for nitric oxide delivered via the GeNO Nitrosyl delivery system is as a diagnostic agent for administration as an adjunct to right heart catheterization in patients with Pulmonary Arterial Hypertension (WHO Group 1) to add information to improve clinical decision making. No agents are currently approved for this indication... [PDF] GeNO's Press Release -

Spectrum Pharmaceuticals : Belinostat Data Presentation at 101st Annual Meeting of the American Association for Cancer Research

Apr 21, 2010 - Data Suggest HDAC Inhibitors, Such as Belinostat, May Be Efficacious in the Treatment of Small Cell Lung Cancer - Results Indicate Synergy With Conventional Chemotherapy Agents - Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, announced results of a pre-clinical study conducted by the National Cancer Institute of belinostat in the treatment of small-cell lung cancer that was presented in a poster session on Wednesday, April 21, 2010 at the 101st Annual Meeting of the American Association for Cancer Research (AACR), being held at the Walter E. Washington Convention Center in Washington, DC.

"Based on the data presented today at AACR, we believe belinostat may be an effective treatment option for small-cell lung cancer,"... Spectrum Pharmaceuticals' Press Release -

Ariad : Preclinical Data on Its Investigational ALK Inhibitor, AP26113, Demonstrating That It Can Overcome Mutation-Based Drug Resistance in Cancer...

Apr 20, 2010 - ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced results of preclinical studies on its investigational anaplastic lymphoma kinase (ALK) inhibitor - AP26113 - showing potent inhibition of the target protein and of mutant forms that are resistant to the first-generation ALK inhibitor, which currently is in clinical trials in patients with cancer. ARIAD scientists presented these data today at the annual meeting of the American Association for Cancer Research (AACR) in Washington, D.C.

Genetic studies indicate that abnormal expression of ALK is a key driver of certain types of non-small cell lung cancer (NSCLC) and neuroblastomas, as well as anaplastic large cell lymphoma. Since ALK is generally not expressed in normal adult tissues, it represents a highly promising molecular target for cancer therapy... ARIAD Pharmaceuticals' Press Release -

Synta Pharmaceuticals : Results at AACR Supporting Correlative Markers for Elesclomol Activity

Apr 20, 2010 - Link demonstrated between elesclomol anti-cancer activity and levels of HIF-1a and LDH - Additional results presented demonstrating activity of elesclomol in cisplatin-resistant lung cancer models - Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced preclinical results presented at the American Association for Cancer Research (AACR) 101st Annual Meeting that support correlative markers for elesclomol anti-cancer activity. In addition, results were presented by Synta collaborators showing that elesclomol demonstrates activity in cisplatin-resistant lung cancer models... Synta Pharmaceuticals' Press Release -

Graceway Pharmaceuticals : Maxair Autohaler Remains Available Through December 31, 2013

04/19/2010 - Graceway Pharmaceuticals, LLC announced that the Food and Drug Administration (“FDA”) published a long-awaited Final Rule regarding the continued availability of Maxair Autohaler (pirbuterol acetate inhalation aerosol) and other pressurized metered-dose inhalers containing chlorofluorocarbons (CFCs). Under the rule, Maxair Autohaler will remain available for physicians and patients through December 31, 2013.

In support of its decision, FDA noted that it received a large number of comments from physicians and patients addressing the public health benefits of pirbuterol – the active ingredient in Maxair Autohaler. FDA likewise observed that the need for patient education was an important factor in extending the effective date of the rule, and the Agency committed to actively monitor the patient transition to CFC-free alternatives... Graceway Pharmaceuticals' Press Release -

Patient Enrollment Complete in Tragara Pharmaceuticals’ Phase II Trial of Capoxigem® in Non-Small Cell Lung Cancer

April 6, 2010 – Tragara Pharmaceuticals, Inc. announced the completion of patient enrollment to its APRiCOT-L study, a phase II clinical trial of its oral, once-daily anti-cancer agent, Capoxigem® (apricoxib, TG01), in non-small cell lung cancer (NSCLC). The APRiCOT-L study is a randomized, double-blind, multi-center, placebo-controlled trial designed to evaluate Capoxigem in combination with erlotinib in second and third line NSCLC patients that have failed a platinum-containing regimen. Tragara is utilizing a biomarker in order to identify the patient population that will benefit most from Capoxigem therapy; biomarker response is an enrollment criterion for the study. The trial enrolled 128 patients and data from the study is expected to be available in Q3 2010.
“The completion of patient enrollment in this study is a significant milestone for Tragara and for the development of Capoxigem in several respects,”... [PDF] Tragara Pharmaceuticals' Press Release -