Cancer Therapy Center

CHICAGO, Oct 17 (Reuters) - Genta Inc. said on Tuesday its lead cancer drug Genasense received orphan drug designation from regulators in Australia allowing for its use to treat patients with late-stage malignant melanoma, a deadly form of skin cancer.

Genta said the designation was granted for the use of Genasense as treatment for patients with Stage IV malignant melanoma. Orphan drug designation is intended to facilitate the development of drugs that address significant unmet medical needs.

It provides seven years of market exclusivity after approval, grants and tax credits for research and development, and reduced filing fees for marketing applications.

The FDA has approved a new drug, Zolinza (manufactured by Pantheon Inc. for Merck & Co) to treat a rare and slow-growing skin cancer, cutaneous T-cell lymphonma. The drug is approved for treatment when the disease persists, gets worse, or comes back after treatment with other medicines.

The approval was won after a study of the safety and effectiveness of Zolinza were evaluated in two clinical trials involving 107 patients with CTCL, each administered the drug after their disease came back or other treatments had failed. Of those patients, 30% saw improvement for an average benefit of 168 days. Some side effects were observed, with the most common serious side effects being blood clots in the lungs, dehydration,deep vein thrombosis, and anemia.

The drug has not been studied in pregnant women, though animal studies suggest Zolinza may harm the fetus.

Cancer Research UK notes that new US research has dramatically changed the current state of understanding of skin cancer. While the traditionally accepted causes (skin cell damage caused by UV radiation) remains the primary cause, researchers have isolated a compound in plants and used that chemical to induce tanning in mice that minimizes UV damage.

Tanning, sunburn and skin cancer are all caused by UV damage to skin cells.

Tanning occurs when the sun’s UV radiation stimulates the most common skin cells, known as keratinocytes.

These then release a hormone known as MSH which tells nearby melanocytes to produce a pigment called melanin, causing tanning.

Using a naturally-occurring compound derived from a plant, known as forskohlin, the researchers were able to simulate the chain of interactions that occurs when MSH stimulates melanocytes.

This created an effect similar to that of a sun tan, without exposing the skin to the sun’s damaging UV rays.

While a tan inducing compound will not alone protect fair skin (providing the equivalent of SPF4 sunscreen), it may allow fair-skinned individuals to obtain a tan in safe conditions, allowing them to skip intentional exposure and obtain a more natural tan than other synthetic tanning methods.