ORLANDO, Fla., May 30 (Reuters) - Synta Pharmaceuticals Corp, which halted trials of an experimental cancer drug in February after it was associated with a higher death rate, said on Saturday the trial showed that a subgroup of skin cancer patients benefited from the drug.
Synta said 80 patients treated with a combination of the drug, elesclomol, and chemotherapy had died as of February, compared with 53 deaths in the chemotherapy alone group.
Preliminary results of the trial found that 170 patients treated with the combination therapy saw their disease worsen, compared with 192 patients treated just with chemotherapy.
The trial enrolled 651 patients with melanoma, a deadly form of skin cancer. As of April, 621 patients had been evaluated.
For patients with normal levels of lactate dehydrogenase (LDH), there were 99 cases of disease progression in the treatment group, compared with 124 in the chemotherapy alone group, according to Synta.
The improvement in the amount of time these patients, who accounted for about two-thirds of the trial total, survived without their cancer worsening was statistically significant, the company said.
'The preliminary safety analysis shows that both the combination and control arms were well tolerated with generally comparable adverse event profiles. The imbalance in deaths observed between the two arms to date cannot be explained by organ-specific toxicities attributable to elesclomol,' Dr Steven O'Day, director of the melanoma program at the Angeles Clinic and Research Institute and the study's investigator, said in a statement.
Synta said final analysis of the trial is expected later this year. Although no patients are currently receiving study treatment, they are being followed for assessment of survival.
'We are encouraged by the signs of clinical activity, and are strongly committed to more fully understanding the underlying science, which could inform the selection of patients for future trials,' Synta Chief Executive Safi Bahcall said in a statement.
(Reporting by Deena Beasley; editing by Carol Bishopric and Eric Beech) Keywords: CANCER MELANOMA/SYNTA (deena.beasley@thomsonreuters.com; + 1 213-955-6746; Reuters Messaging: deena.beasley.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
Synta said 80 patients treated with a combination of the drug, elesclomol, and chemotherapy had died as of February, compared with 53 deaths in the chemotherapy alone group.
Preliminary results of the trial found that 170 patients treated with the combination therapy saw their disease worsen, compared with 192 patients treated just with chemotherapy.
The trial enrolled 651 patients with melanoma, a deadly form of skin cancer. As of April, 621 patients had been evaluated.
For patients with normal levels of lactate dehydrogenase (LDH), there were 99 cases of disease progression in the treatment group, compared with 124 in the chemotherapy alone group, according to Synta.
The improvement in the amount of time these patients, who accounted for about two-thirds of the trial total, survived without their cancer worsening was statistically significant, the company said.
'The preliminary safety analysis shows that both the combination and control arms were well tolerated with generally comparable adverse event profiles. The imbalance in deaths observed between the two arms to date cannot be explained by organ-specific toxicities attributable to elesclomol,' Dr Steven O'Day, director of the melanoma program at the Angeles Clinic and Research Institute and the study's investigator, said in a statement.
Synta said final analysis of the trial is expected later this year. Although no patients are currently receiving study treatment, they are being followed for assessment of survival.
'We are encouraged by the signs of clinical activity, and are strongly committed to more fully understanding the underlying science, which could inform the selection of patients for future trials,' Synta Chief Executive Safi Bahcall said in a statement.
(Reporting by Deena Beasley; editing by Carol Bishopric and Eric Beech) Keywords: CANCER MELANOMA/SYNTA (deena.beasley@thomsonreuters.com; + 1 213-955-6746; Reuters Messaging: deena.beasley.reuters.com@reuters.net) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.