Point Therapeutics planning to evaluate talabostat against range of cancers

By Jennifer Lanning Drey

Eugene, Ore., June 1 - Point Therapeutics, Inc. is planning to aggressively evaluate talabostat in multiple tumor models for potential use in a wide range of cancers, said Don Kiepert, president and chief executive officer for Point, in a presentation at the Friedman Billings Ramsey 2006 Growth Investor Conference.

The company also announced Thursday that talabostat has been granted fast track designation from the Food and Drug Administration for the treatment of stage 3B/4 non-small cell lung cancer.

Talabostat is an oral, targeted dipeptidyl peptidase inhibitor in clinical development for potential use in oncology and pre-clinical development for type 2 diabetes and immune responses to vaccines.

"As a small company, we wanted to find indications where there were unmet needs because we believe that gives us the fastest to-market opportunity," said Kiepert during the conference.

In oncology, Point's development strategy is focused on exploring talabostat's efficacy across solid tumors as well as malignancies.

The company is also looking at talabostat as both a single agent and in combination with other anti-cancer agents, said Kiepert.

Point estimates the market opportunity for talabostat could be more than $1 billion, he said.

"If approved, this would be a drug that would have great applications across a lot of tumors in combination with lots of different therapies," he said.

"We have extensively studied our compound pre-clinically in over 25 different tumor models and have consistently seen very potent activity."

In its non-small cell lung cancer program, Point is running two phase 3 randomized, double-blind, placebo-controlled trails consisting of 400 patients each. The company plans to have results from the clinical trials published at the end of 2007 and, if successful, a product launch for non-small cell lung cancer in the second half of 2008, according to Kiepert.

With fast track designation, Point can submit sections of its New Drug Application for talabostat on an ongoing basis, as they are completed.

In addition, Point expects to have results from a phase 2 chronic lymphocytic leukemia trial in December and final results on its phase 2 pancreatic cancer treatment in the first half of 2007.

Partnership top priority

Securing a partner is a top priority in the company's commercialization strategy, and Point has targeted completing a collaboration agreement in the second half of the year, Kiepert said.

The company will also seek outside sponsors for studies to look at talabostat in additional tumor models, he said.

Point plans to present new data on talabostat's anti-tumor activity in advanced chronic lymphocytic leukemia, metastatic melanoma, metastatic colorectal cancer and in a preclinical osteosarcoma model at the American Society of Clinical Oncology Annual Meeting, which is being held in Atlanta from June 2 to 6.

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

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