Monday, May 05, 2014 4:12:49 PM
Today: Monday 5 May 2014
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release products for treating eye diseases, today announced that the Company presented the first peer-reviewed preclinical data demonstrating the use of pSivida’s Tethadur™ technology to provide sustained release of Avastin at the 14th Annual Meeting of ARVO (Association for Research in Vision and Ophthalmology).
pSivida’s Dinesh K. Nadarassan presented a poster entitled “Sustained Release of Bevacizumab (Avastin) from BioSilicon”. The data from preclinical studies conducted by pSivida concluded that long-term sustained release of antibodies such as Avastin is achievable with Tethadur, a form of pSivida’s BioSilicon™ technology, and that the release of the antibodies is controllable over a wide range by adjusting the pore size and surface area of Tethadur.
“The implications of the ability to control the duration of sustained delivery of antibodies through pore size are significant,” said Dr. Paul Ashton, president and chief executive officer of pSivida. “By varying pore size, we believe the release rate of antibodies loaded into Tethadur can be controlled, which could permit sustained delivery of antibodies that currently must be delivered by frequent injections. For example, Avastin and the two of the top-selling Veg-F ophthalmic drugs today are injected as frequently as once a month.”
pSivida’s Tethadur, an application of BioSilicon technology, is designed to provide sustained delivery of large biologic molecules, including peptides, proteins and antibodies. BioSilicon technology utilizes a fully-erodible, honeycomb structure of nano-porous, elemental silicon to provide sustained delivery of therapeutics. The study evaluated the effect of pore size in Tethadur on Avastin release over a period of three weeks.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technologies, Durasert™ and Tethadur™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., is marketed in the U.K. and Germany and has also received marketing authorization in Austria, France, Portugal, and Spain and is awaiting authorization in Italy. Alimera has filed for ten additional EU country approvals through the Mutual Recognition Procedure. Alimera is seeking FDA approval for ILUVIEN for DME in the US. pSivida has commenced a Phase III clinical trial of Medidur™ for the treatment of posterior uveitis, a chronic back-of-the-eye disease, which uses the same micro-insert as ILUVIEN. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension, a product candidate on which Pfizer Inc. has an option. pSivida's FDA-approved Retisert®, licensed to Bausch & Lomb Incorporated, provides long-term, sustained drug delivery to treat posterior uveitis.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: ability of BioSilicon and Tethadur to successfully deliver proteins, peptides and other large biologic molecules on a sustained basis; Alimera's ability to obtain regulatory approval for, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; Alimera's ability to finance, achieve additional marketing approvals, obtain adequate pricing and reimbursement for, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU; the ability to finance, complete and achieve a successful outcome for Phase III trials for, and file and achieve marketing approvals for, Medidur for posterior uveitis, including achieving acceptable risk-to-benefit and safety profiles in light of the CRL for ILUVIEN; initiation, financing and success of Latanoprost Product Phase II trials and any exercise by Pfizer of its option; ability to develop product candidates and products and potential related collaborations; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; continued sales of Retisert; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty income; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
Martin E. Janis & Company, Inc.
Beverly Jedynak, President
+1 312.943.1123
M: +1 773.350.5793
bjedynak@janispr.com
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