The New Jersey-based company seems committed as ever to the drug's approval and has decided to conduct a randomised controlled Phase III study of Genasense (oblimersen sodium) Injection in patients with advanced melanoma - the most deadly form of skin cancer.

Genta said it has sought scientific advice on final aspects of the trial design from regulatory agencies in Europe and the US and said it is now actively recruiting experienced investigative sites in Europe, Australia, and North and South America in order to start patient recruitment this summer.

The trial is designed to expand evidence for the safety and efficacy of Genasense combined with Bayer's dacarbazine (DTIC) - a drug commonly used in the treatment of metastatic melanoma - for patients who have not previously been treated with chemotherapy.

The new study will prospectively target patients, using a biomarker that identified those who gained maximal benefit, based on the results from a previous Phase III clinical trial.

"The announcement of this trial reaffirms our long-standing commitment to patients afflicted with advanced melanoma," said Dr Raymon Warrell, Genta's CEO.

"The use of a standard biomarker to target specific patients should facilitate completion of this study in a considerably smaller population, and if positive, worldwide regulatory submissions."

Genasense - an antisense drug - has suffered several setbacks in the last three years, with the first in May 2004 when the US Food and Drug Administration (FDA) advisory panel refused to support the drug's approval. Genta withdrew its new drug application (NDA) for the drug in the treatment of skin cancer as a result.

Last month, Genta suffered another blow, in Europe this time, when it was informed that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA) is likely to issue a negative opinion on Genasense marketing authorisation application for patients with advanced melanoma.

And more recently, the FDA rejected Genasense's NDA which proposed the use of the drug - also in combination with chemotherapy - to treat patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The FDA's decision inflicted a $1.3m (€1m) impairment on the company's fourth quarter results.

But Genta doesn't seem to be giving up its hopes. Earlier this month, the biotech firm filed a formal appeal to the FDA.

Genta should hear back from the agency's Center for Drug Evaluation and Research (CDER) by mid-June as responses to CDER appeals are typically made within 30 to 60 days.

A positive outcome for this appeal could represent the end of the tunnel for Genta and securing the market launch of Genasense would help it fix its woes. The firm reported a net loss of $56.8m for the year 2006 compared to a net loss of $2.2m in the previous year.