Will Genta's Quest for FDA Approval Pay Off?
Genta Incorporated [[GNTA.OB]] is one of the hottest stocks on the OTC market right now thanks to the promise of its Genasense anti-cancer drug. Preclinical trials suggested that the drug synergizes with most types of anti-cancer treatments in order to reduce the expression of targeted proteins known to have critical functions in the development and progression of cancer and resistance to therapies.
The core of Genasense is its “antisense” DNA mechanism that is engineered in a sequence that is exactly “opposite” or complimentary to the coding sequence of a target mRNA for the purposes of binding it to the target mRNA. Specifically, the antisense molecule in Genasense is chemically modified by the substitution of sulfur for one of the non-binding oxygen atoms to bind to the Bcl-2 gene.
The Bcl-2 gene has been implicated in a number of cancers, including melanoma, breast, prostate, and lunch carcinomas, as well as schizophrenia and autoimmunity. The gene is also thought to be involved in resistance to conventional cancer treatments, which supports a role for decreased apoptosis in the pathogenesis of cancer. As a result, experts believe that targeted this gene could prove beneficial.
Genasense’s binding process with the Bcl-2 gene hybridizes with and inactivates the mRNA, which prevents the troublesome protein from being formed. Furthermore, numerous studies have confirmed that Genasense’s method of targeting the critical Bcl-2 gene is superior to other oligonucleotide leads on the market, giving it great promise in the future, despite some disappointments.
Genta originally submitted its application to the FDA in December 2005 for Genasense. However, an FDA advisory panel in September 2006 voted 7-3 that the drug did not demonstrate substantial evidence of effectiveness as a chemotherapy sensitizer in CLL. Three months later, regulators agreed and denied Genasense’s application. In April 2007, the company appealed the decision, but was again rebuffed.
In March 2008, 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 submit the follow-up data, which showed a significant increase in overall survival. In July 2008, the FDA accepted Genta’s amended application and set December 2008 as the action date. However, the drug was again denied “in its present form” and the FDA recommended additional clinical studies.
Recently, the Genta announced that it has completed its patient enrollment into AGENDA – its Phase III trial of Genasense Injection into patients with advanced melanoma. The company is hoping that the randomized, double-blind, placebo-controlled trial will support global registration of Genasense for patients with advanced melanoma. The study was designed to confirm certain safety and efficacy results obtained in a prior random trial of Genasense combined with dacarbazine in patients who have not previously received chemotherapy.
In the end, investors are now hoping that the most recent Phase III trials will prove once and for all that Genasense is a viable drug for cancer patients. However, given its past trackrecord, prudent investors may want to wait on the sidelines while speculators take advantage of the volatility in the stock.
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