pSivida Announces Completion of BrachySil Dose Ranging Study in Pancreatic Cancer
WATERTOWN, Mass.--(Business Wire)--
pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FF:PV3), a leading drug delivery company
today 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.
"BrachySil has once again produced encouraging clinical results with 100% of
patients experiencing stabilization in tumor growth," said Dr. Paul Ashton,
President and CEO of pSivida Corp. "We are very encouraged by the results of
both this dose ranging study and the prior safety study."
BrachySil is a novel oncology product which comprises a combination of
BioSilicon (a proprietary porous silicon) and the isotope 32Phosphorus, a proven
anti-cancer therapeutic. It is hoped this product will provide oncologists with
an effective and user-friendly new treatment for this disease which has a high
unmet clinical need.
Pancreatic cancer is the fourth most frequent cause of cancer death in the
United States, and at least 80% of patients present with inoperable locally
advanced or metastatic disease. The median survival for these patients following
diagnosis is typically less than six months with standard chemotherapy.
Accordingly, there is significant clinical and market demand for effective
therapies.
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