OXiGENE Receives U.S. Orphan Drug Designation for CA4P to Treat Glioma
June 10 2016 - 8:30AM
OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing
vascular disrupting agents (VDAs) for the treatment of orphan
oncology indications, today announced that the U.S. Food and Drug
Administration (FDA) has granted orphan drug designation to CA4P
for the treatment of glioma. The designation provides for seven
years of marketing exclusivity following product approval. CA4P has
previously received orphan drug designation from the FDA for the
treatment of ovarian cancer, neuroendocrine tumors and certain
thyroid cancers.
Glioma is a broad category of brain tumors that grow from glial
cells, and includes glioblastoma multiforme (GBM), which is
particularly aggressive and often spreads quickly. OXiGENE has
preclinical data that demonstrate a positive treatment effect of
CA4P in GBM models.
“I am pleased that the FDA has provided orphan designation to
CA4P for the treatment of glioma,” stated William D. Schwieterman,
M.D., President and Chief Executive Officer of OXiGENE.
“While the principal focus of our clinical development program
remains on ovarian cancer, we continue to expand the potential
indications and improve our proprietary position for CA4P as part
of our novel platform of vascular targeted therapies in
oncology.”
Orphan designation can be granted by the FDA to product
candidates that are intended to treat rare diseases that generally
affect fewer than 200,000 people in the United States.
About OXiGENE
OXiGENE is a biopharmaceutical company seeking to realize the
full potential of vascular targeted therapy in orphan oncology
indications. Vascular targeted therapy includes vascular disrupting
agents (VDAs), such as the investigational drugs that OXiGENE is
developing, and anti-angiogenic agents (AAs), a number of which are
approved and widely used in oncology indications.
OXiGENE’s VDAs selectively obstruct a tumor’s blood supply
without obstructing the blood supply to normal tissues, and
treatment with our VDAs has been shown to lead to significant
central tumor necrosis. The company believes that the treatment of
cancer would be significantly improved if VDAs and AAs are used
together, due to their complementary mechanisms of action. In
combination, the VDA would occlude the blood vessels in the
interior of a tumor while the AA would prevent the formation of new
tumor blood vessels.
Safe Harbor Statement
This news release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995. Any or all of the forward-looking statements in this
press release, which include the timing of advancement, outcomes,
data and regulatory guidance relative to our clinical programs and
achievement of our business and financing objectives may turn out
to be wrong. Forward-looking statements can be affected by
inaccurate assumptions OXiGENE might make or by known or unknown
risks and uncertainties, including, but not limited to, the
inherent risks of drug development, manufacturing and regulatory
review, and the availability of additional financing to pursue and
continue development of our programs. Additional information
concerning factors that could cause actual results to materially
differ from those in the forward-looking statements is contained in
OXiGENE's reports to the Securities and Exchange Commission,
including OXiGENE's reports on Form 10-K, 10-Q and 8-K.
However, OXiGENE undertakes no obligation to publicly update
forward-looking statements, whether because of new information,
future events or otherwise. Please refer to our Annual Report
on Form 10-K for the fiscal year ended December 31, 2015.
Investor and Media Contact:
ir@oxigene.com
650-635-7000