Directors of Perth headquartered global bio-nanotech company pSivida Ltd have confirmed that they will be taking up rights to subscribe for pSivida shares under their respective individual eligible entitlements to raise approximately $29 million.
Directors of Perth headquartered global bio-nanotech company pSivida Ltd have confirmed that they will be taking up rights to subscribe for pSivida shares under their respective individual eligible entitlements to raise approximately $29 million.
Capital raised from this rights issue will primarily fund the phase III clinical trials of Medidur for the treatment of Diabetic Macular Edema, and phase IIa clinical trials of our lead BioSilicon product, BrachySil which is being developed for the treatment of inoperable pancreatic cancer.
The rights issue is on a non-renounceable 1 for 8 basis to raise approximately $29 million at 60 cents per ordinary share, and has an incorporated top up facility whereby eligible shareholders may apply for additional new ordinary shares in excess of their entitlement at the same price.
The rights issue is not underwritten. The record date for the rights issue was 22 May 2006.
pSivida also announced the Regulatory Agency in the U.K. (The Medicines and Healthcare Products Regulatory Agency) has granted approval to proceed with the first human study of its BrachySil product in pancreatic cancer through a phase IIa clinical trial.
The six month clinical study which has been approved to proceed by the MHRA is a phase IIa trial in patients with inoperable pancreatic cancer and will be undertaken at two leading centers for cancer treatment, Guys & St Thomas' Hospital in London and Singapore General Hospital.
The trial represents the "first-in-Man" safety study for BrachySil in this indication and is designed to enrol a total of 15 patients. The primary objective is to determine the safety of the targeted image-guided implantation of BrachySil. Efficacy, as determined by CT scanning of the tumour size and overall survival, will be secondary endpoints.
The findings will provide a platform for further multi-centre efficacy and safety trials.
Earlier this month, pSivida was looking to raise $29 million through a non-renounceable rights issue to fund clinical trials for two of its treatments.
The capital raised would be used to fund the phase III clinical trials of Medidur for the treatment of Diabetic Macular Edema (DME), and phase IIa clinical trials of BrachySil.
At market close, shares in pSivida were up 1.5 cents to 60 cents.
Below are the full announcements:
Global bio-nanotech company pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) is pleased to announce that the Regulatory Agency in the U.K. (TheMedicines and Healthcare Products Regulatory Agency or MHRA) has granted approval to proceed with the first human study of BrachySil™ in pancreatic cancer through a phase IIa clinical trial.
Pancreatic cancer is a second clinical indication for BrachySilTM, currently in Phase IIb clinical trials for the treatment of inoperable primary liver cancer. Pancreatic cancer has one of the lowest cancer survival rates (5 year overall survival rate of approximately 5%).
There is significant clinical and market demand for effective therapies to treat this aggressive form of cancer. According to *GLOBOCAN, there were over 230,000 new cases and nearly as many deaths from pancreatic cancer worldwide in 2002. Approximately 50% of these new cases were in North America and Europe.
The six month clinical study which has been approved to proceed by the MHRA is a phase IIa trial in patients with inoperable pancreatic cancer and will be undertaken at two leading centres for cancer treatment, Guys & St Thomas' Hospital in London (UK) and Singapore General Hospital.
The trial represents the "first-in-Man" safety study for BrachySil™ in this indication and is designed to enrol a total of 15 patients. The primary objective is to determine the safety of the targeted image-guided implantation of pSivida's BrachySil™ product. Efficacy, as determined by CT scanning of the tumour size and overall survival, will be secondary endpoints.
The findings will provide a platform for further multicentre efficacy and safety trials.
Pre-clinical evaluation of BrachySil™ into pancreatic cancers has provided the teams involved in the clinical trial with valuable feedback allowing optimisation of BrachySil™ for this indication and standardisation between the two study centres.
The clinical program will utilise product sourced from the same GMP manufacturing process and supply chain which is currently being utilised for the liver cancer program. The manufacturing process is established and scaled up to support clinical development and early launch volumes.
A phase IIa study for advanced inoperable liver cancer completed in June 2005 on eight patients showed BrachySil™ to be both safe and well tolerated. All patients experienced a decrease in the size of their tumours, with some experiencing complete tumour regression.
"We have recently announced progress with the development of BrachySil™, our targeted oncology product, in primary liver cancer. We believe that because the BrachySil™ primary liver program is in Phase IIb clinical trials, it will provide valuable clinical information for the development and commercialisation of BrachySil™ for pancreatic cancer and other indications," said pSivida CEO, Mr Gavin Rezos.
"We also believe that gaining regulatory agency approval in Europe to begin the first clinical study for the pancreatic cancer indication represents a very positive milestone towards broader value generation from BrachySil™."
pSivida Directors to take up Entitlements under the Rights Issue
Boston, MA. and Perth, Australia - Global bio-nanotech company pSivida Limited (ASX:PSD, NASDAQ:PSDV, Xetra:PSI) is pleased to announce that the Directors of the Company have confirmed that they will be taking up rights to subscribe for pSivida shares under their respective individual eligible entitlements.
Capital raised from this Rights Issue will primarily fund the phase III clinical trials of MedidurTM for the treatment of Diabetic Macular Edema (DME), and phase IIa clinical trials of our lead BioSiliconTM product, BrachySilTM which is being developed for the treatment of inoperable pancreatic cancer.
The Rights Issue is on a non-renounceable 1 for 8 basis to raise approximately A$29 million at A$0.60 per ordinary share, and has an incorporated top up facility whereby eligible shareholders may apply for additional new ordinary shares in excess of their entitlement at the same price.
The Rights Issue is not underwritten. To the extent there is any shortfall under the Rights Issue, pSivida has agreed to place such shortfall through Janney Montgomery Scott LLC, its US based Lead Manager for this issue, to institutional and sophisticated investors.
The Record Date for the Rights Issue was 22 May 2006. The ordinary shares to be issued in connection with the Rights Issue are expected to commence trading on the Australian Stock Exchange on 8 June 2006. Applications will close on 7 June 2006. The period for placement of the shortfall is expected to be between 7 and 13 June 2006.
