Genta Incorporated has initiated a new clinical study that will evaluate the company's lead anticancer drug, Genasense (oblimersen sodium) injection in patients with advanced melanoma. This trial is the first follow-on study to Genta's randomized phase 3 trial of Genasense plus dacarbazine that showed benefit across multiple clinical endpoints in patients with advanced melanoma who had not previously received chemotherapy.
The new study represents the rapid clinical translation of preclinical results that demonstrated marked anticancer synergy when Genasense was combined with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (Abraxis BioScience, Inc.) and Temodar (temozolomide) Capsules (Schering-Plough, Corporation).
The new pilot study will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the three-drug combination in chemotherapy-naïve patients whom have normal levels of a key biomarker, serum lactate dehydrogenase (LDH). Several dosing schedules will be examined in order to develop a regimen that may optimize safety and efficacy for additional testing. The study will be led by Dr. Anna Pavlick, Director, NYU Melanoma Program, assistant professor of medicine and dermatology, New York University Cancer Institute, New York.
The activity of this drug combination is supported by preclinical data that were presented earlier this month in Prague at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.
"Our goal with this trial is to further evaluate the potential for Genasense to synergize with a taxane combined with temozolomide, drugs that are widely used in patients with advanced metastatic melanoma," commented Dr Pavlick. "Genasense has demonstrated significant benefit in melanoma patients compared with dacarbazine chemotherapy used alone. We hope that this new combination may provide an enhanced level of anti-melanoma activity using a "patient friendly" regimen for patients who suffer with this devastating disease."
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.