Key Developments For Psivida Corp.
Psivida Corp. (PSDV.O) (Consolidated Issue listed on NASDAQ Global Market)
pSivida Corp. Announces Completion Of BrachySil Dose Ranging Study In Pancreatic Cancer
pSivida Corp. announced the completion of a second pancreatic clinical trial of BrachySil (P32 BioSilicon), a potential new brachytherapy treatment for inoperable pancreatic cancer. Six patients were studied at two centers in the UK (Guy`s and St Thomas` NHS Foundation Trust and University Hospital, Birmingham). The study was conducted to determine the safety of escalating radiation doses of the BrachySil device and to determine an optimum dosing level. Tumor response was also measured as a secondary end point. The study escalated the absorbed targeted radiation dose by four-fold from the previous study to 400 Gy (Gy or Gray is a unit of absorbed radiation dose due to ionizing radiation). No device related serious adverse events were experienced at the elevated levels and independent dosimetry experts have concluded from the data that 400 Gy is the optimum dose. The previous safety study presented last year at the American Society of Clinical Oncology-GI showed that BrachySil in combination with standard chemotherapy (gemcitabine), was well tolerated with no clinically significant adverse events related to the device. Data in the first study showed disease control in 82% of patients. BrachySil is implanted directly into the tumor and was found to be easily deliverable by endoscopic ultrasound.
pSivida Corp. Announces Safety And Efficacy Results From 18-Month Interim Readout Of Human PK Iluvien Study
pSivida Corp. announced the interim 18-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien. The PK trial is being conducted by Alimera Sciences, the licensee for Iluvien. This present 36-month, open-label, Phase II study is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide (FA), after administration of Iluvien in patients with DME. Secondarily, the PK Study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK Study, 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms (µg) per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45µg per day dose). In the 18-month interim readout, data again demonstrated no adverse events related to intraocular pressure (IOP) in low dose patients, and a similar level of increased IOP in the high dose patients as reported at 12 months. No patients receiving the low dose of Iluvien experienced IOP increases of 30 millimeters of mercury (mmHg) or greater at any time point, while 29% of the patients receiving the high dose of Iluvien experienced IOP increases of 30mmHg or greater at some time point. In this trial, a subset of 11 patients in the high dose group and 13 patients in the low dose group met the visual acuity inclusion criteria of the nearly 1000 patient Phase III FAME trial.
pSivida Corp. Announces New Iluvien Pilot Study In Patients With Macular Edema Secondary To Retinal Vein Occlusion
pSivida Corp. announced that enrollment has begun for a pilot study to assess the safety and efficacy of Iluvien in patients with macular edema secondary to retinal vein occlusion. The trial is being sponsored by pSivida's licensee, Alimera Sciences of Alpharetta, Georgia.
pSivida Corp. Reports Iluvien Phase III Studies for DME Pass Final DSMB Review Prior to October Readout
pSivida Corp. annoujced that an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of two pivotal Phase III clinical trials for the use of Iluvien (formerly known as Medidur FA) in the treatment of diabetic macular edema (DME) under the current protocol, without change. The clinical trials are being conducted by the Company's licensing partner, Atlanta-based Alimera Sciences, Inc. Top line data from the trials is expected to be available at the end of this year. The DSMB completed its final review of the currently available safety and efficacy data prior to the 24 month readout scheduled in October 2009. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies. These clinical trials, known collectively as the FAME Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, doublemasked, randomized, multi-center trials in the U.S., Canada, Europe and India in support of a planned global registration filing. The NDA will be filed with safety and efficacy assessed after 24 months of follow-up.
pSivida Corp Announces CFO Resignation
pSivida Corp. announced that Michael Soja has resigned his position as Vice President, Finance and Chief Financial Officer(CFO) to pursue other interests, effective March 20, 2009. The Company`s Corporate Controller, Len Ross, will become the Principal Financial and Accounting Officer.
