Prostate cancer vaccine Provenge (sipuleucel-T) to hit markets soon

Provenge (sipuleucel-T), a vaccine to treat prostate cancer from Dendreon Corporation may reach market within a year’s time.

Dendreon Corporation has completed the submission of the amended Biologics License Application (BLA) for Provenge (sipuleucel-T) to the U.S. Food and Drug Administration (FDA).

Provenge (sipuleucel-T) is meant for men with metastatic castrate-resistant prostate cancer (CRPC).

Provenge (sipuleucel-T) would represent the first product in the new therapeutic class known as active cellular immunotherapies.

Provenge (sipuleucel-T)’s BLA submission includes data from the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) trial, which was conducted under a Special Protocol Assessment agreement with the FDA.

Provenge (sipuleucel-T)’s The multi-center, randomized, double-blind, placebo-controlled, IMPACT study met its pre-specified primary endpoint demonstrating a statistically significant improvement in overall survival in men with metastatic CRPC, Dendreon said an official release.

FDA declined to approve the medicine until data from the IMPACT study confirmed earlier trends.

IMPACT study included 512 men with late-stage prostate cancer who have not benefited from drugs that sharply lower testosterone — the male sex hormone that fuels progression of the cancer.

“We look forward to working with the FDA to potentially make Provenge the first active cellular immunotherapy to be licensed in the United States,”said Mitchell H. Gold, MD, president and chief executive officer of Dendreon.

Provenge (sipuleucel-T) is Dendreon’s investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies (ACIs) specifically designed to engage the patient’s own immune system against cancer.

Provenge (sipuleucel-T) will be the first therapeutic vaccine — vaccines that prevent disease, unlike traditional vaccine.

Dendreon’s Provenge (sipuleucel-T) medicine treats it by stimulating the body’s own immune system.

Besides, Provenge has also prolonged the chances of survival after afflicted with prostate cancer.

However, Provenge can be very costly, as well.

Provenge stood to be a $200 million product if it is approved only in the advanced prostate cancer patient group, but could expand to a $1 billion blockbuster if it is expanded to men with earlier stages of the disease, according to analysts.

Dendreon plans to market Provenge on its own in the United States, but it said it remains interested in a marketing partner overseas.

The leading current treatment for advanced prostate cancer is Taxotere, a Sanofi-Aventis, a chemotherapy that can cause harsh side effects, including neuropathy, hair loss, nausea and vomiting.

OrbiMed’s Borho predicted Provenge, which is administered only once, would cost more than $50,000. and other ACIs are uniquely designed to use live human cells to engage the patient’s own immune system with the goal of eliciting a specific long-lasting response against cancer.

Provenge (sipuleucel-T) is available through several ongoing clinical trials, including OpenACT, an open label trial enrolling men with metastatic CRPC, ProACT (PROstate cancer Active Cellular immunoTherapy), and NeoACT (NEOadjuvant Active Cellular immunotherapy).

Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer. An estimated 192,280 new cases are expected to be diagnosed in 2009. Approximately 27,360 men are expected to die this year from the disease,according to the American Cancer Society.

Headquartered in Seattle, Washington, Dendreon Corporation is a biotechnology company with expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response.

Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia.