FDA informs Novartis of extension to US regulatory review period for QAB149, a novel once-daily bronchodilator for treatment of COPD

March 23, 2011 - Novartis announced that the US Food and Drug Administration (FDA) has extended the regulatory review period for QAB149 (indacaterol) for the once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

The FDA asked for a three-month extension in order to complete its review of the new drug application (NDA) for QAB149 by July 2011. In its notification, the FDA said it needed more time to examine the data submitted by Novartis in support of the application. The agency did not request additional data.

"This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical program resulting in a large amount of data to be reviewed," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "COPD is a life-threatening lung disease and a major cause of serious long-term disability[1]. We remain committed to bringing new therapies to patients who suffer from this condition."... Novartis' Press Release -

Stempeutics Research : DCGI nod to start Phase II clinical trial for four debilitating diseases

January 20 th, 2011 – Stempeutics Research a group company of Manipal Education & Medical Group announced that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by Manipal Group and Cipla...


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...Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a disease of the lungs in which the airways become narrowed. This leads to a restriction to the flow of air to and from the lungs causing shortness of breath. Currently the available treatment options are targeted at only symptomatic relief of COPD, which do not provide long term benefits to the patients. Mesenchymal stem cells are thought to stimulate the endogenous stem cells and help them to differentiate into alveolar epithelium, thus repairing the lung damage and improving pulmonary function. This study involves the evaluation of safety and efficacy of “Stempeucel” in COPD and finding the appropriate safe and effective dose for the disease... [PDF] Stempeutics Research's Press Release -

Forest Laboratories : FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD...

Mar 01, 2011 - Forest Announces FDA Approval of DalirespTM (Roflumilast) as a Treatment to Reduce the Risk of COPD Exacerbations in Patients with Severe COPD Associated with Chronic Bronchitis and a History of Exacerbations - Forest Laboratories, Inc. (NYSE: FRX) announced that Daliresp [TM] (roflumilast) was approved by the U.S. Food and Drug Administration (FDA) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The efficacy and safety of Daliresp was evaluated in eight clinical studies including 9,394 adult patients.

COPD is an under-diagnosed, progressive, irreversible lung disease. Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm. A significant worsening of symptoms - called an exacerbation - can last several weeks and often requires substantial medical intervention, including hospitalization.

Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved and is an oral tablet taken once daily. While the specific mechanism by which Daliresp exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells. Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011... Forest Laboratories' Press Release -

Theratechnologies : new clinical program in muscle wasting in Chronic Obstructive Pulmonary Disease (COPD)

February 22, 2011 - Theratechnologies (TSX: TH) announced a new clinical program for muscle wasting in Chronic Obstructive Pulmonary Disease (COPD) using the Company's lead compound, tesamorelin, a human growth hormone releasing factor ("GRF") analogue.
Based on tesamorelin's anabolic properties, the Company has chosen to pursue the development of its lead compound in muscle wasting in patients with COPD as its second indication. COPD is characterized by progressive airflow obstruction due to chronic bronchitis or emphysema leading in certain cases to muscle wasting, a decrease of muscle mass and deterioration in functionality. Previously, Theratechnologies completed a Phase 2 trial in stable ambulatory COPD patients which demonstrated a statistically significant increase in lean body mass. The Company intends to commence a second Phase 2 clinical study in the second half of 2011 to test different dosages of tesamorelin with a new formulation... Theratechnologies' Press Release -

Helix BioPharma: European Clinical Trial Application For A Phase I/II Study Of Its Lung Cancer Drug Candidate L-DOS47

February 24, 2011 – Helix BioPharma Corp. (TSX, NYSE Amex, FSE: “HBP”), a developer of biopharmaceutical drug candidates for the prevention and treatment of cancer,announced that it has filed a clinical trial application (“CTA”) with the Central Register of Clinical Trials at the Polish Ministry of Health seeking approval to perform its planned Phase I/II clinical safety, tolerability and preliminary efficacy study of its lung cancer drug candidate L-DOS47.
L-DOS47 is Helix’s first therapeutic immunoconjugate drug candidate under development based upon the Company’s novel DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction.L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic, non-small cell lung cancer (“NSCLC”)... [PDF] Helix BioPharma's Press Release -