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Vion says analyses of CLI-033 show Cloretazine may be viable to treat elderly, poor-risk leukemia patients
By E. Janene Geiss
Philadelphia, Dec. 12 - Vion Pharmaceuticals, Inc. said Monday that retrospective analyses of the elderly patients with poor-risk leukemia enrolled to Vion's clinical trial, CLI-033, show that Cloretazine may be a viable treatment for these patients.
In this trial, 107 elderly patients with previously untreated acute myelogenous leukemia or high-risk myelodysplasia received induction therapy with Cloretazine, according to a company news release.
The company said it has previously announced an overall response rate of 32% and an early death rate (death within 30 days of treatment from any cause) of 18% for this stratum.
Two abstracts on these analyses were presented at the American Society of Hematology annual meeting in Atlanta, officials said.
"The information presented in these posters provides evidence that the patients in Stratum A of CLI-033 represent an elderly population with poor-risk leukemia for whom standard induction treatment may not be an option. We continue to believe that both the anti-leukemic activity and the acceptable toxicity profile demonstrated in this poor-risk patient group indicate that Cloretazine is a viable treatment for this unmet medical need," Ann Cahill, vice president of clinical development, said in the release.
The company said it is scheduled to meet with the U.S. Food and Drug Administration in January 2006 in an End-of-Phase 2 meeting to discuss these data.
In October 2005, the company announced that it received Fast-Track designation from the FDA for Cloretazine for the treatment of previously untreated elderly patients with poor-risk cute myelogenous leukemia.
Vion is a New Haven, Conn., pharmaceutical company developing cancer therapeutics.
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