PhiloGene, Inc. Announces that VEGFb(TM) has been Granted Orphan Drug Designation...

PhiloGene, Inc. Announces that VEGFb(TM) has been Granted Orphan Drug Designation by the FDA for the Treatment of Advanced Melanoma

SUMMIT, N.J.--(Business Wire)--
PhiloGene, Inc. announced that the U.S. Food and Drug
Administration (FDA) has granted orphan drug designation to VEGFb for
the treatment of patients with advanced melanoma. This approval is for
a larger subset of melanoma patients than was requested, and includes
melanoma in stages IIb through IV.

Orphan drug status is granted by the FDA to encourage
biotechnology and pharmaceutical companies to develop drugs that
demonstrate promise for the treatment of rare diseases, which affect
fewer than 200,000 people in the United States. Orphan Drug status
will afford PhiloGene seven years of marketing exclusivity for the
drug, once the FDA ultimately approves VEGFb.

"This is a significant milestone and accomplishment for
PhiloGene," commented Miriam Mangelus, PhD MBA, CEO of PhiloGene. "We
are very pleased to receive this support from the FDA, as it
represents a significant validation of the promise of VEGFb. The
orphan drug approval will enable us to accelerate the process to make
VEGFb available to treat patients with advanced malignant melanoma.
This in turn will help the company to develop VEGFb for additional
cancers, retinal disorders (wet macular degeneration and diabetic
retinopathy), and other diseases."

About VEGFb

PhiloGene's most advanced program, VEGFb (Vascular Endothelial
Growth Factor "b"), is a naturally occurring anti-angiogenic
(angiogenesis: growth of new blood vessels) factor. VEGFb causes
regression of abnormal blood vessels, such as those that are essential
for the growth and survival of tumors. VEGFb also prevents the growth
of abnormal new blood vessels generated in eye diseases, such as wet
macular degeneration and diabetic retinopathy. Extensive efficacy
animal data indicate that VEGFb is safe, potent, and a specific
anti-angiogenic factor that inhibits tumor growth and abnormal
vascularization in the eye. VEGFb is also a survival factor that is
essential for many tissue types in the body such as endothelial cells
(cells that line the inside of blood vessels), kidney tissue, neurons
in the eye and other cell types. Preclinical data indicates that
VEGFb's survival effects will prevent most of the side effects seen
with the current generation of anti-angiogenic drugs.

The discovery of VEGFb, the native anti-angiogenic form of VEGF,
and the elucidation of the mechanisms that control the balance between
the pro- and anti-angiogenic forms of VEGF is a paradigm shift from
current therapeutic approaches. Current therapeutic approaches are
non-specific and remove both, the pro- and anti-angiogenic forms of
VEGF. PhiloGene's completely novel approach is more selective and
specific. To treat cancer, VEGFb is administered to patients to create
a therapeutic ratio of the pro- and anti-angiogenic forms of VEGF. As
a result, the tumor's blood vessels and the tumor fed by these blood
vessels both regress. The elegance of PhiloGene's approach is that it
utilizes the body's endogenous, natural, homeostatic system that
controls the creation and/or regression of blood vessels. In animal
models of human cancer, the administration of VEGFb has led to the
complete disappearance of a variety of established human tumors.

VEGFb and Melanoma

The incidence of melanoma has increased more rapidly than any
other cancer during the past ten years. According to the American
Cancer Society, melanoma accounts for approximately five percent of
all skin cancers, but causes about 75% of all skin cancer-related
deaths. An estimated 60,000 people will be diagnosed, and nearly 8,200
people will die from melanoma this year in the U.S. alone. If
diagnosed and surgically removed, while localized in the outermost
skin layer, melanoma is potentially curable; however, for patients
with metastatic disease, the prognosis is poor. Treatments are limited
and the expected duration of survival for patients with metastatic
melanoma is only six to nine months.

A recent study in patients with malignant melanoma showed that
VEGFb is down-regulated in primary tumors from patients who
subsequently developed metastasis. This suggests that low levels of
VEGFb may be a component of the metastatic process. Subsequently, in a
preclinical model of human melanoma, two subcutaneous injections of
VEGFb0 substantially reduced the formation of melanoma metastasis over
a 14-day period. In at least one case, all metastasis were eliminated.
This is an astounding early result in one of the most difficult of
cancers to treat, in which existing drugs are not very effective.

The discovery of is VEGFb is a revolutionary advance in medicine
and in the understanding of tumor biology and the treatment of solid
cancers. In addition to melanoma, VEGFb has shown positive results in
a variety of preclinical human cancer models including: colon, breast,
bladder, renal, prostate, sarcoma, and other cancer types.

About PhiloGene

PhiloGene Inc. is a biopharmaceutical company focused on
developing and commercializing novel protein therapeutics for unmet
medical and patient needs. PhiloGene exploits the therapeutic
potential of native growth and differentiation factors. The first drug
in PhiloGene's pipeline is VEGFb, which is a dual action drug to treat
cancer and provide positive cytokine actions. Because the
anti-angiogenesis pathway is one of the most validated and explored in
medicine, the development path for VEGFb will be accelerated. VEGFb is
not only "first in class," but also in a class by itself: a
revolutionary, dual action, anti-angiogenic drug. PhiloGene has a
worldwide, exclusive license for the anti-angiogenic family of VEGFb
proteins form Bristol University, UK.

Issued by PhiloGene Inc. http://www.philogene-inc.com/

PhiloGene, Inc.
President
Dr. Mendi Ze'evi, 908-998-2402
mendi.zeevi@philogene-inc.com
or
Bus. Dev.
Stephen Rowe, 617-794-2220
steve.rowe@philogene-inc.com
or
The University of Bristol
Dr. Sandie Cree, +44 (0)117 9546968
www.mvrl.org

Copyright Business Wire 2008