West Coast Editor

Less than a month after disclosing the next step of its Phase II study with talabostat for leukemia - and days after winning an FDA grant for the drug - Point Therapeutics Inc. launched the most advanced trial yet with the compound, starting its Phase III program to test talabostat in metastatic non-small-cell lung cancer.

Point's stock (NASDAQ:POTP) closed Friday at $4.12, down 5 cents.

Having gained the FDA's blessing in an end-of-Phase II meeting, Point will test its lead candidate in Phase III trials in patients afflicted with Stage IIIb/IV NSCLC who have failed platinum-based chemotherapy. Two trials will be conducted in as many as 800 patients at about 100 sites in North America.

"We plan to report results by the end of 2007," said Donald Kiepert, CEO, founder, president and chairman of Boston-based Point.

The first 400-patient study already has opened to enrollment and will evaluate oral talabostat in combination with docetaxel vs. docetaxel with placebo. The second will test the drug in combination with pemetrexed vs. pemetrexed with placebo. Docetaxel and pemetrexed are the current standard of care in that advanced patient population.

Progression-free survival is the primary endpoint, with secondary endpoints including overall survival, objective response rate, complete response, duration of response and quality of life.

Less than a week ago, Point said it had won an Orphan Products Development grant of $600,000 from the FDA to fund its Phase II study of talabostat in combination with rituximab in advanced chronic lymphocytic leukemia. The two-year award aims to encourage development of products for rare diseases or conditions, usually affecting less than 200,000 people in the U.S., and Point plans to finish the Phase II trial in CLL and decide whether to proceed with Phase III during the first quarter of next year. In September, the company completed the first stage of the Phase II study.

Talabostat also is being studied in two Phase II trials against Stage IV melanoma, as a single agent and with cisplatin.

"Those trials are fully enrolled, and we'll be making a decision at the end of this year about whether or not we want to initiate a Phase III program," Kiepert said.

In June, Point began a Phase II trial with the compound combined with gemcitabine against metastatic pancreatic cancer. The indication "happens to be a really good tumor to target," he said, because of the unmet need and because of talabostat's mechanism of action.

"If we got positive [Phase II] results in pancreatic cancer, that probably would be the fastest approval process," Kiepert said, but so far NSCLC takes the lead position.

"We had very compelling preclinical data to [move this into] our first Phase II," he said, adding that talabostat "stacks up very favorably with drugs that have been approved for second-line treatment."

In Phase II, five out of 36 patients responded, and two of those were complete, "which is highly unusual in second-line treatment," Kiepert noted. Of those two, one was second-line and one was third-line, and one had failed docetaxel. They were identified as complete responders in February and March, and are still being monitored.

DPP inhibitors also might work against Type II diabetes, since DPP-4 has been reported to regulate GLP-1, an important metabolic system signaling protein that promotes insulin secretion in response to dietary sugars. Point has PT-630, which has a high affinity to DPP-4, in preclinical study. Also at the early stage is PT-510 as a vaccine adjuvant for infectious diseases.

"We're not aware of any other programs in development that work to this mechanism," Kiepert said, though he acknowledged as a contender Wellesley, Mass.-based Coley Pharmaceutical Group Inc.'s Toll-like receptor agonist ProMune, which is in Phase II trials for NSCLC, among other indications.

"A lot of companies are pursuing that approach," he said.

ProMune is partnered with Pfizer Inc., of New York. Point hopes to have a partner for talabostat by the middle of next year.

"This is a drug that, if approved, could have such broad use that really we need to make sure we have a good distribution channel," Kiepert told BioWorld Today. "We've been actively talking to potential partners, and our discussions have moved forward quite well."

The goal is to structure an arrangement that would split profits and allow Point to co-develop and co-promote.

"We would like to have a small sales force, to make sure we can protect our drug once it moves into the marketing phase," he said.