Point Therapeutics says talabostat exceeding expectations in treating leukemia

By Ted A. Knutson

Washington, Dec. 12 - Point Therapeutics, Inc. presented positive interim results Monday, exceeding the company's targeted 20% response rate, in its ongoing phase 2 study of talabostat in combination with rituximab, a monoclonal antibody, in patients with advanced chronic lymphocytic leukemia (CLL).

The results were included in a poster session at the American Society of Hematology Annual Meeting in Atlanta.

"The fact that the addition of talabostat to rituximab is demonstrating positive results - especially in patients who had failed rituximab in the past - is very exciting. The toxicity profile is low and because talabostat is orally administered, it's easy for patients to take at home - a convenience they like," said Dr. Khuda Dad Khan, a lead investigator in Point's CLL trial at Indiana Oncology Hematology Consultants.

"I believe talabostat has the potential to become an important treatment option for advanced CLL, especially for patients who have exhausted other choices."

Don Kiepert, president and chief executive officer of Point Therapeutics, said the company anticipates making a decision about the next steps for its phase 2 CLL trial during the first quarter of 2006.

The research, a single-arm trial, evaluates talabostat in combination with rituximab in up to 54 evaluable patients with advanced CLL who have failed fludarabine and/or rituximab.

Thus far, 36 patients have entered the study and 31 meet criteria for evaluability of at least six days of talabostat with a post-baseline assessment by the investigator. Precisely 66.7% of the patients in the study are Rai Stage IV, the most advanced CLL patient population.

Investigators have reported clinical responses in seven of 31 evaluable patients for an overall response rate of 22.5%. One of the seven responses is awaiting follow-up assessment to confirm the response. Five of the seven responses were observed in patients who had previously not responded to or had relapsed following prior treatment with rituximab - suggesting that the addition of talabostat is providing additive activity. Importantly, three of these five patients had not only failed fludarabine and rituximab, but had also failed prior alemtuzumab treatment - the only approved agent in fludarabine failures.

Responses are evaluated based on the National Cancer Institute working group guidelines for CLL, which is the standard used in measuring treatment effectiveness in CLL. The most frequent adverse events are those commonly reported with rituximab, including nausea, fever, difficult/labored breathing, fatigue and itching, with the exception of peripheral edema, which is associated with talabostat.

The trial is continuing to enroll, and all patients will continue to be followed for durability of response, progression-free survival and survival.

This trial is partially funded through an Orphan Products Grant from the Food and Drug Administration. The grants are awarded by the FDA to encourage clinical development of products for use in rare diseases or conditions, usually defined as affecting fewer than 200,000 people domestically.

Point is a Boston-based biopharmaceutical company developing a family of dipeptidyl peptidase (DPP) inhibitors for use in cancer, type 2 diabetes and as vaccine adjuvants.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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