Two Newly-Published Scientific Papers Showed That the Steroid Used in Company's Iluvien Device Acted as Both a VEGF Inhibitor and Neuroprotectant
“The results of these two studies, showed for the first time that FA acted as both a VEGF (vascular endothelial growth factor) inhibitor as well as a neuroprotective,” explained Dr. Ashton, CEO of pSivida and a co-author of these papers. “These properties support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase II trials are currently underway; and other degenerative conditions such as retinitis pigmentosa. Dr. Ashton noted that no currently approved treatment for these conditions provide both VEGF inhibitive and neuroprotective qualities.
The first study, “Fluocinolone inhibits VEGF expression via
glucocorticoid receptor in human retinal pigment epithelial (ARPE-19)
cells and TNF-alpha-induced angiogenesis in chick chorioallantoic
membrane (CAM)” was published in the April issue of
The second study, “Photoreceptor neuroprotection in RCS rats via
low-dose intravitreal sustained-delivery of flucinolone acetonide”
published on line in Investigative Ophthalmology & Visual Science,
with print publication scheduled for August, studied the neuroprotective
effects of FA delivered through a Medidur-device in RCS. Authors Dr.
About
pSivida is a world leader in the development of miniaturized,
injectable, drug delivery systems for the eye. pSivida’s lead
development product, Iluvien™, delivers fluocinolone acetonide (FA) for
the treatment of diabetic macular edema (DME). Formerly known as
Medidur™ FA for DME, Iluvien is in fully recruited Phase III clinical
trials. pSivida has licensed certain drug delivery technology to
pSivida owns the rights to develop and commercialize a modified form of silicon known as BioSilicon™, which has potential therapeutic applications. The most advanced BioSilicon product candidate, BrachySil™, delivers a therapeutic P32, a radioactive form of phosphorus used to treat cancer, directly to solid tumors. pSivida has completed an initial safety clinical trial of BrachySil for the treatment of pancreatic cancer and is conducting a follow-on dose-ranging clinical trial.
pSivida’s intellectual property portfolio consists of 45 patent
families, over 100 granted patents, including patents accepted for
issuance, and over 200 patent applications. pSivida conducts its
operations from
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM
ACT OF 1995: Various statements made in this release are forward-looking
and involve a number of risks and uncertainties. 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 forward-looking statements: failure of FA or
the Iluvien device to act as a VEGF inhibitor or neuroprotectant;
inability to expand the treatment indications for Iluvien; maintaining
key collaboration agreements with Alimera and Pfizer; modification of
existing terms of key collaboration agreements with Alimera and Pfizer;
uncertainties regarding the achievement of milestones and other
contingent contractual payment events; failure to prove safety and
efficacy of Iluvien or BrachySil; inability to raise capital; continued
losses and lack of profitability; inability to derive revenue from
Retisert; termination of license agreements; inability to pay any
registration penalties; inability to develop or obtain regulatory
approval for new products; inability to protect intellectual property or
infringement of others’ intellectual property; inability to obtain
partners to develop and market products; competition; risks and costs of
international business operations; manufacturing problems; insufficient
third-party reimbursement for products; failure to retain key personnel;
product liability; failure to comply with laws; failure to achieve and
maintain effective internal control over financial reporting; impairment
of intangibles; volatility of stock price; possible dilution through
exercise of outstanding warrants and stock options or future stock
issuances; possible influence by Pfizer; and other factors that may be
described in our filings with the
Source:
In US:
Beverly Jedynak
312-943-1123
bjedynak@janispr.com
or
In
Australia:
Brian Leedman, Vice President, Investor Relations,
pSivida Corp.
+61 8 9227 8327
brianl@psivida.com
