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...


[...]

...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 -

Clear Catheter Systems : US FDA Clearance for the PleuraFlow Active Tube Clearance System

December 13, 2010 — Clear Catheter Systems, Inc, a Bend, Oregon-based medical device company, announced that it has received US Food and Drug Administration clearance for its innovative PleuraFlow™ Active Tube Clearance System. This is a device that can be widely deployed in the post operative management of patients requiring heart and lung surgery. The company has approval to market the device in Europe and Canada, and this regulatory approval clears the way to market the product in the United States for patients recovering from cardiothoracic surgery.
When chest tubes become clogged blood can build up around the heart and lungs which can lead to complications and even death. The PleuraFlow System employs a proprietary active tube clearance system which allows the medical professional to maintain a functioning chest tube in the post operative period... [PDF] Clear Catheter Systems' Press Release -

APP Pharmaceuticals : Approval and Launch of Topotecan for Injection

Nov 30, 2010 - APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market Topotecan for Injection, and plans to launch immediately.

Topotecan for Injection is therapeutically equivalent to the reference-listed drug Hycamtin(R), which is currently marketed by the innovator GlaxoSmithKline, plc. According to IMS data, U.S. sales of Hycamtin(R), in 2009 were $157.1 million.

Topotecanfor Injection is indicated for small cell lung cancer sensitive disease after failure of first-line chemotherapy, and is also indicated for use in combination therapy with Cisplatin for stage IV-B, and for recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. APP will market Topotecanfor Injection in 4 mg single dose vials; the product is bar-coded and preservative-free... APP Pharmaceuticals' Press Release -

IsoRay : Its Revolutionary Internal Radiation Therapy for Lung Cancers is Focus of National Study

October 13, 2010 -… IsoRay, Inc. (Amex: ISR) announced the initiation of a multi-institutional study of Cesium-131 brachytherapy seeds (internal radiation therapy) for use in Non Small Cell Lung Cancers (NSCLC). A number of institutions and physicians will be working to collect scientific data to further the use of Cesium-131 internal radiation therapy in conjunction with surgery for NSCLC. The study expands participation in the application of the breakthrough internal radiation treatment. It allows doctors to aggressively treat lung cancer using a single procedure upon tumor removal that is demonstrating its impact as a new vital weapon in the war on cancer.
Lung cancer continues to be the leading cause of cancer deaths worldwide. There are two main types of lung cancer - Small Cell Lung Cancer and Non Small Cell Lung Cancer. Non Small Cell Lung Cancer is the most common type of lung cancer. Some 8 to 9 out of 10 cases of all lung cancer cases are non small cell type. This year alone, an estimated 225,000 cases of lung cancer will be diagnosed of which some 80% will be Non Small Cell Lung Cancer... [PDF] IsoRay's Press Release -

Amakem : COPD drug development program

November 15, 2010 - Amakem receives 1.28M€ government funding for COPD drug development program - Localized Drug Action platform addresses side effects – Amakem announces that it has been awarded 1.28M€ by the Flemish government agency for Innovation by Science and Technology (IWT) to support its Rho kinase (ROCK) inhibitor-based drug development program for chronic obstructive pulmonary disease (COPD).
Amakem was founded early this year by Dirk Leysen (CSO) and Olivier Defert (director external R&D), both former Devgen researchers. Jack Elands (CEO), who joined shortly thereafter, comments: “COPD is a serious disease for which no cure exists. So-called kinase inhibitors hold great promise, but many have failed in clinical trials because of their limited therapeutic window. To address this fundamental problem with such kinase based drugs we developed our „Localized Drug Action‟ platform."
Amakem focuses on making drugs safer by limiting or avoiding systemic exposure, thereby reducing side effects caused in non target organs... [PDF] Amakem's Press Release -

China Medical Technologies : SFDA Approval for its First Self-Developed PCR-based EGFR Assay for Lung Cancer Targeted Drugs

Nov. 10, 2010 - China Medical Technologies, Inc. (the "Company") (Nasdaq: CMED), a leading China-based advanced in-vitro diagnostic ("IVD") company, announced that it has received approval for its real-time PCR-based Epidermal Growth Factor Receptor ("EGFR") Assay (the "EGFR PCR Assay") for the use of lung cancer targeted drugs from the State Food and Drug Administration of China (the "SFDA").

The EGFR PCR Assay is used for the detection of the 28 most common somatic mutations in the EGFR gene of patients with non-small cell lung cancer ("NSCLC") and provides a qualitative assessment of mutation status to determine the use of lung cancer targeted drugs for patients.

With its own internal research and development efforts, the Company has successfully developed its first PCR-based assay related to companion diagnostic tests for personalized medicines for cancer patients. The Company's EGFR PCR Assay is the first PCR-based EGFR assay for the use of lung cancer targeted drugs approved by the SFDA... China Medical Technologies' Press Release -

Synergenz BioScience Awarded Therapeutic Discovery Project Grant

Nov. 2, 2010 – Synergenz BioScience, Inc., a leader in predictive risk stratification for smoking-related lung cancer, was awarded a research grant under the Federal Government’s Qualifying Therapeutic Discovery Project (QTDP) program.

The $94,836 grant will assist Synergenz’s ongoing clinical utility trials for Respiragene™, a genetic-based test for lung cancer predisposition. Respiragene™ identifies the subset of individuals most likely to develop lung cancer from their smoking habit -- before disease strikes -- allowing doctors to improve preventative care for a cancer usually diagnosed too late to save their patients... Synergenz's Press Release -

Sequella : International Support for Phase 2 Clinical Trials of SQ109, its Lead Antitubercular Drug Candidate

October 18th, 2010 - Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa.
The Phase 2 studies, which will support international regulatory submissions, will be performed by the Pan African Consortium for Evaluation of Antituberculosis Antibiotics (PanACEA). The studies will be funded by a €12 million grant by the European and Developing Countries Clinical Trials Partnership (EDCTP) and a €3 million commitment by Sequella for in-kind and corporate funding. The multi-year clinical program will be directed by Professor Michael Hoelscher, Department of Infectious Diseases and Tropical Medicine, University Hospital of LMU, in conjunction with Sequella.
“TB is a global health problem that will only be solved by international cooperation and focus on improvement in patient care,” said Dr. Carol A. Nacy, CEO of Sequella. “We are excited by the opportunity to work with EDCTP, the LMU, and the very talented group of TB experts in PanACEA to further the clinical development of SQ109.”... [PDF] Sequella's Press Release -

ImmuneWorks : National Clinical Trial for New Idiopathic Pulmonary Fibrosis (IPF) Treatment

October 19, 2010 - Biotechnology Firm ImmuneWorks Begins National Clinical Trial for New Idiopathic Pulmonary Fibrosis (IPF) Treatment – ImmuneWorks, Inc. announced the initiation of its Phase I clinical trial in patients suffering from idiopathic pulmonary fibrosis (IPF), a serious lung disease. The clinical trial will move the biotech company one step closer to commercialization of its lead IPF treatment compound.

Eight leading academic research universities will conduct the IPF clinical trial: Indiana University, Medical University of South Carolina, Ohio State University, University of Alabama-Birmingham, University of Chicago, University of Louisville, University of Michigan and University of Vermont.

“We are pleased to move forward into clinical investigation of our purified Type V collagen solution in patients suffering from IPF... ImmuneWorks' Press Release -

Radient Pharmaceuticals And Provista Life Sciences : New Blood Test For Lung Cancer

October 13, 2010 – Provista Life Sciences and Radient Pharmaceuticals Corporation (RPC) (NYSE AMEX: RPC) announced the validation study results of a blood test for early detection of lung cancer and Provista’s plans to broadly introduce this new test to market.
The study completed the requisite analyses and data evaluation needed to validate Provista’s test, based on Radient Pharmaceutical Corporation’s antigens for fibrinogen degradation products (FDP), successfully detects lung cancer with a high degree of accuracy. The study included men and women between 2076 years of age. The data generated in this final study proved consistent with previous findings and produced positive clinical performance marks of 87% sensitivity; 95% specificity; and an ROC Accuracy of 0.97. By industry standards the study proved very successful and will serve as the cornerstone to Provista’s efforts to introduce a new lung cancer detection assay branded LC Sentinel™ to market.

Provista intends to introduce LC Sentinel™ as a CLIA Laboratory Developed Test (LDT) for use in highrisk
lung cancer patient populations in the U.S. by the end of the fourth quarter 2010 through its standard clinical channels that include physicians, medical clinics and hospitals. The company expects to seek FDA registration for LC Sentinel™ in 2011... [PDF] Radient Pharmaceuticals' Press Release -

Linde RSS expands REMEO® offering to include pediatric respiratory services

September 30, 2010 -- Linde RSS has signed an agreement to provide respiratory care services to pediatric residents at St. Margaret’s Center in Albany, New York. The agreement constitutes an extension of the Linde REMEO® respiratory service, which has traditionally been offered to adults. The agreement comes on the heels of St. Margaret’s decision to expand its current facility so it could offer more comprehensive pediatric respiratory services.
Linde RSS is an affiliate of Linde North America, which is a member of The Linde Group, a world-leading healthcare, gases and engineering company. St. Margaret’s, which started as a home for abandoned children 127 years ago, now provides services to residents with unique physical, mental and emotional needs throughout New York State and beyond. With the expansion, St. Margaret’s is increasing its capacity to 94 residents, which ranges from newborns to young adults.

Linde will provide a turn-key respiratory solution that includes therapists, gases and equipment that are included in the company’s REMEO® program for innovative care of mechanically ventilated patients. St. Margaret’s pediatric nurses will work side-by-side with the Linde respiratory team to provide highly specialized care, 24-hours a day.

“Linde impressed us with their clinical focus and comprehensive respiratory therapy offering... Linde's Press Release -