Offering new hope for advanced pancreatic cancer patients, Point Therapeutics Inc. reported preliminary results from a Phase II trial of talabostat showing that almost half of the evaluable patients for a survival endpoint have lived more than six months following treatment.

Point's stock (NASDAQ:POTP) jumped 21.2 percent on the news Friday. It rose 18 cents, and closed at $1.03.

Out of 21 evaluable patients, 10 - or 48 percent - have survived more than six months, the primary endpoint.

Patients were treated with talabostat plus gemcitabine. The single arm, two-stage Phase II study is enrolling up to 60 evaluable patients with Stage IV metastatic pancreatic cancer.

According to the American Cancer Society, the prognosis for pancreatic cancer patients, particularly those with Stage IV disease, is grim. The one-year relative survival rate for all stages of the disease is 24 percent, and the five-year rate is about 5 percent.

In 2006, there were 33,730 new cases of pancreatic cancer and 32,300 people died of the disease in the U.S. That type of cancer has a poor prognosis because symptoms often do not appear until the disease spreads to other organs. It can be controlled through surgery only if caught early. If it has spread, palliative treatment may control the symptoms and complications of the disease, but that is no cure.

In Point Therapeutics' trial, three (9.7 percent) of 31 patients evaluable for tumor response showed a clinical response to treatment, including one complete response and two partial responses. A patient with metastatic disease to the liver experienced a complete disappearance of tumor. Preliminary data have not uncovered any unexpected toxicities, and the trial will continue as planned with final results expected in the middle of this year.

Secondary endpoints of the Phase II trial include overall survival, progression-free survival, quality of life and performance status.

An oral agent, talabostat is an inhibitor of fibroblast activation protein, an enzyme highly expressed in pancreatic cancer and one believed to promote tumor growth. The drug has a dual mechanism of action in which it disrupts the tumor stroma and reduces metastases, and also stimulates the innate and acquired immune systems to attack the tumor directly.

The company predicts talabostat can be used with existing therapies to offer a higher likelihood of attacking solid tumors. Preclinical studies have shown the drug has demonstrated a significant response with several chemotherapies, including docetaxel, pemetrexed, dacarbazine, cisplatin, gemcitabine, paclitaxel and 5-FU, and with monoclonal antibodies such as rituximab and trastuzumab.

Point Therapeutics has said a major advantage over other therapies is talabostat's convenient oral formulation and its dosing flexibility. Typically, adverse events include edema and fatigue.

In addition to pancreatic cancer, talabostat is being evaluated for non-small-cell lung cancer and is in two Phase III double-blind, placebo-controlled trials, one in combination with docetaxel (Taxotere, Sanofi-Aventis) and the other in combination with pemetrexed (Alimta, Eli Lilly & Co.). Results are expected by the end of the year.

The company received fast-track designation from the FDA for talabostat in the Stage IIIB/IV NSCLC indication last summer.

Talabostat also has been studied in several Phase II trials as a single agent in metastatic melanoma and in combination with cisplatin in the same indication, as well as in combination with rituximab for advanced chronic lymphocytic leukemia.

Aside from talabostat, Point Therapeutics is working on another dipeptidyl peptidase inhibitor, PT-630. The product is in preclinical development for Type II diabetes. PT-630 is different from marketed products in that it offers prolonged inhibition of DPP-4, a once-per-day dosage, decreased HbA1c, reduced triglyceride levels, reduced glucose levels and improvement in insulin sensitivity. Development of the product is on hold, however, as Point Therapeutics concentrates on its later-stage talabostat trials.

To that end, the company reduced its work force by 15 percent last year to control expenses and see the Phase III program through to completion. It has forecast a quarterly cash spend this year of $6 million.

As of Sept. 30, the company had a cash and investment balance of about $16 million.