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U.S. FDA Grants Orphan Drug Status to PI-88 for Melanoma
BRISBANE, Australia, May 3 /PRNewswire-FirstCall/ -- Progen Industries Limited
, a progressive Australian anti-cancer drug development company, announced
today that it has received orphan drug designation from the U.S. Food and Drug
Administration (FDA) for their lead anti-angiogenesis product PI-88 for
treatment of malignant melanoma. Orphan drug designation will provide PI-88
seven years market exclusivity when approved for this disease indication.
The U.S. Orphan Drug Act is intended to encourage companies to develop
therapies for the treatment of diseases that affect fewer than 200,000
individuals. Additional criteria include the ability of the product to address
unmet medical need where no approved treatment option exists or, the provision
of significant benefit over other available treatments. Under the Act, upon
marketing authorization and during the period of market exclusivity, the FDA
does not accept or approve other applications to market the same medicinal
product for the same therapeutic indication. In addition to potential market
exclusivity, orphan drug status provides up to 50% in U.S. tax credits, grant
funding for research and development and reduced filing fees, expedited review
as well as advice on the conduct of clinical trials.
PI-88, is one of a new class of multi-targeted cancer therapeutics inhibiting
both angiogenesis or tumor promoting factors such as Vascular Endothelial
Growth Factor (VEGF), Fibroblast Growth Factors 1 and 2 (FGF-1 and -2) and
heparanase, an enzyme implicated in tumor metastasis (tumor spread). PI-88 is
undergoing a Phase II clinical program in metastatic melanoma as a single agent
therapy; advanced non-small cell lung cancer (NSCLC) in combination with
chemotherapy (Taxotere(R)); as adjuvant treatment in post- operative primary
liver cancer (imminent); and as a single agent therapy in multiple myeloma
(completed).
"We believe the strength of PI-88 resides in its ability to inhibit both
angiogenesis and metastasis simultaneously and we have seen evidence that this
potential might be realized across a variety of cancers," stated Robert Don
PhD, Progen's VP of Research and Development. "The FDA's orphan drug
designation further strengthens our program for PI-88 by offering important
accelerated clinical development and commercialization benefits. We are
pleased and gratified by the Agency's support of our efforts to bring PI-88 to
patients with this deadly disease."
DATASOURCE: Progen Industries
CONTACT: Sarah Meibusch of Progen Industries, +61-7-3273-9100,