[MOL] FDA grants orphan Drug designation to ALLOVECTIN-7 for MELANOMA TR [00711] Medicine On Line


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[MOL] FDA grants orphan Drug designation to ALLOVECTIN-7 for MELANOMA TREATMENT....



FDA Grants Orphan Drug Designation To Allovectin-7 For Melanoma Treatment



SAN DIEGO, CA -- October 28, 1999 -- Vical Inc. today announced that its lead product candidate, Allovectin-7, has been granted orphan drug designation for the treatment of invasive and metastatic melanoma by the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development.

Orphan drug designation provides U.S. marketing exclusivity for seven years upon marketing approval by the FDA, in addition to tax benefits. Leading cancer centers throughout the United States are currently recruiting patients with metastatic melanoma for Phase III and Phase II registration trials with Allovectin-7.

Melanoma is a skin cancer found predominantly in Caucasians, most often in fair-skinned people susceptible to sunburn. Exposure to sunlight, particularly UVB rays, is considered the primary cause. The incidence of melanoma is doubling every six to 10 years among affected populations, with 44,200 new cases and 7,300 deaths estimated for 1999 in the United States.

Melanoma frequently spreads to tissues beneath the skin and to internal organs, most often the lymph nodes, lungs, brain, or liver. If the disease progresses to Stage III, defined as limited regional metastases, treatment may involve surgical removal of the tumors and any affected lymph nodes, followed by systemic or local chemotherapy with single or multiple agents. The five-year survival rate for treated Stage III patients is about 60 percent, and quality of life is often compromised by both the disease and the treatment.

Allovectin-7, which uses a lipid-DNA complex to help the immune system recognize and attack cancer cells, is in Phase II and Phase III testing in certain patients with metastatic melanoma and in Phase II testing in patients with unresectable head and neck cancer.

Warmly, lillian
 
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