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news.Point Therapeutics has been awarded a $600,000 orphan products development grant from the FDA to fund its phase II study of talabostat in combination with rituximab in advanced chronic lymphocytic leukemia.
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Orphan products development grants are awarded by the FDA to encourage clinical development of products for use in rare diseases or conditions, usually defined as affecting less than 200,000 people in the US.
Chronic lymphocytic leukemia (CLL) is an incurable disease that usually affects people over 60 years of age. Patients who present with advanced stage disease or who progress to the state of requiring treatment have a poor outcome with a median survival of only 18 to 36 months.
On September 19, 2005, Point announced that it had achieved a 20% clinical response rate in the first 20 evaluable patients in the first stage of the company’s phase II CLL study. This was the targeted response rate needed to continue the study to completion.
“We are very pleased to be one of the few corporate programs to receive an Orphan products development grant this year,” said Don Kiepert, president and CEO of Point Therapeutics. “This award, coupled with the positive results we recently announced, positions Point to complete the phase II CLL trial and make a phase III go/no-go decision in the first quarter of 2006.”