Wednesday, January 13th, 2010
Genta Gets a Second Wind with Its Ganite Drug
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Genta Incorporated (OTC:GETA) hasn’t been entirely successful in developing its cancer drug Genasense®, but its small molecule program and Ganite® drug candidate could represent promising potential and could represent a second wind for the company!
Genta Incorporated (GETA) is a biopharmaceutical company focused on developing drugs for the treatment of cancer and related diseases. The company began with the development of its Genasense® drug, but has now refocused somewhat on its small molecule program…
A Rocky Road for Genasense® Trials
Genta began development of its Genasense® anti-cancer drug long ago and first submitted its application to the FDA in December 2005. However, an advisory panel voted 7-to-3 in September 2006 that the drug did now demonstrate substantial evidence of effectiveness.
After being rebuffed again in April 2007, regulators requested that Genta either conduct a new clinical trial or collect follow-up data from patients from its earlier Phase III studies. The company opted to use the follow-up data, which showed a significant increase in survival.
In July 2008, the FDA accepted Genta’s amended application and set December 2008 as the action date. However, the drug failed again “in its present form” and the FDA recommended additional studies in order to move forward.
Since then, Genta has completed enrollment in its AGENDA Phase III randomized, double-blind, placebo-controlled trial of Genasense® in patients with advanced melanoma. But, initial results did not show statistically significant differences in overall response.
Despite the setback, Genta announced that it plans to continue to follow patients on AGENDA in order to determine the survival endpoint and durable response and overall survival endpoints. But, the company did recently note that its high-dose IV infusion showed promising activity.
New Successes Possible with Ganite®
Ganite® has a thesis entirely separate from Genasense®, which works by inhibiting the production of a protein called Bcl-2. Instead, Ganite® operates using gallium-containing compounds that are potent inhibitors of bone resorption.
Many diseases are associated with accelerated bone loss, including osteoporosis, cancer, Paget’s disease, and others. For instance, diseases like osteoporosis involve bone loss over a period of years, while cancer-related hypercalcemia involves a very rapid rate of bone loss.
It turns out that gallium reduces bone loss by inhibiting calcium resorption from the bone. Preclinical evidence suggests that the mechanism of gallium action is multifactorial and different from other current therapies used to treat bone loss.
Recently, Genta highlighted the publication of two scientific studies that test the active ingredients in its program to develop orally available gallium-containing compounds and the company’s marketed product, Ganite®.
The studies showed that extended treatment with the active ingredient significantly increased bone volume and calcium content in animals with induced osteoporosis. Moreover, the increase in bone formation was associated with a significant restoration of bone strength.
Given the wide range of diseases that this drug could be applied to, Genta’s Ganite® represents a substantial development that could be big dividends down the road.
The Takeaway…
- Genta hasn’t had a lot of success with its Genasense® cancer drug to date, as the FDA continues to wait for additional study results before approval.
- Genta’s Ganite® products may represent a new line of drugs with powerful potential, competing in the large markets from osteoporosis to cancer-related diseases.
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-- Written by Rick Telfur
