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 -