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PhiloGene, Inc. announces that VEGFb(TM) has been granted orphan drug designation by the FDA for the treatment of advanced melanoma

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Tuesday, July 22, 2008

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

Source: PhiloGene Inc.
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