FDA Accepts CyDex Pharmaceuticals IND Application for Oncology DrugCyDex Pharmaceuticals announced that the U read more http://www.clobetasocream.com .S. Has Food and Drug Administration , the company ‘s Investigational New Drug application for a clinical trial of Captisol enable Melphalan HCL accepted . Melphalan is an FDA-approved low dose chemotherapy for multiple myeloma under the brand name Alkera marketed by GlaxoSmithKline. In December 2008, CyDex orphan drug status by the FDA for melphalan as a high-dose conditioning before hematopoietic progenitor cells stem cell transplant. This designation represents an important economic incentive, granting CyDex seven years of market exclusivity. IND acceptance for Captisol-enabled melphalan is an important milestone for CyDex as we work to new drugs new drugs for the hospital acute care market, said Theron E. CyDex President and Chief Executive Officer. We look forward to a relationship with a strategic licensing partner CDX-353 in the clinic and promote long-term, Captisol to develop and commercialize this promising oncology product .
The study cohort includes 181 men with Gleason score 8-10 CaP with androgen deprivation therapy , brachytherapy and external radiation treatment in combination between 1994 and 2006. The study is non-randomized, single-institution and retrospective. The ADT was supplied for 3 months by brachytherapy and then 2 months later concomitant ADT and inherits followed. The total ADT duration was 9 months. 103Pd was the isotope for all brachytherapy and most men received a dose of 45 Gy with 100Gy inherits. Median follow-up was 65 months and the Phoenix definition of PSA recurrence was used.
Patient is – provider communication influences the quality of supply, however Schwarz and Asian patients were more frequent than white patients to communication problems with her doctors in 2005 Reports, to the latest Messaging and Facts from the Agency for Healthcare Research and quality of.