-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, WOrONqkjNpp7yA53hJXAR7S+VwJ/PW76Basv0J/LMfwph8XX3a1Rxoq6wbQtodaG Ojd/5YeCElX600w5x8oClQ== 0001157523-06-005754.txt : 20060601 0001157523-06-005754.hdr.sgml : 20060601 20060601153756 ACCESSION NUMBER: 0001157523-06-005754 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060601 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060601 DATE AS OF CHANGE: 20060601 FILER: COMPANY DATA: COMPANY CONFORMED NAME: POINT THERAPEUTICS INC CENTRAL INDEX KEY: 0000919745 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043216862 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23776 FILM NUMBER: 06880006 BUSINESS ADDRESS: STREET 1: 155 FEDERAL STREET CITY: BOSTON STATE: MA ZIP: 02110 BUSINESS PHONE: 6179332130 MAIL ADDRESS: STREET 1: 155 FEDERAL STREET CITY: BOSTON STATE: MA ZIP: 02110 FORMER COMPANY: FORMER CONFORMED NAME: HMSR INC DATE OF NAME CHANGE: 20010618 FORMER COMPANY: FORMER CONFORMED NAME: HEMASURE INC DATE OF NAME CHANGE: 19940315 8-K 1 a5161109.txt POINT THERAPEUTICS, INC. 8-K SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): June 1, 2006 POINT THERAPEUTICS, INC. (Exact Name of Registrant as Specified in Charter) DELAWARE 0-19410 (State or Other Jurisdiction (Commission File Number) of Incorporation) 155 FEDERAL STREET, BOSTON, MASSACHUSETTS 02110 (Address of Principal Executive Offices) Registrant's telephone number, including area code: (617) 933-2130 N/A (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Item 8.01 Other Events Point Therapeutics, Inc. ("Point") issued a press release on June 1, 2006 announcing that the U.S. Food and Drug Administration has granted talabostat Fast Track Designation for the treatment of Stage IIIB/IV non-small cell lung cancer patients who have failed prior platinum-based chemotherapy. A copy of the press release dated June 1, 2006 is being filed as Exhibit 99.1 to this Current Report on Form 8-K. Item 9.01 Financial Statements and Exhibits. (c) Exhibits. 99.1 - Press release issued by Point dated June 1, 2006. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. POINT THERAPEUTICS, INC. June 1, 2006 By: /s/ Donald R. Kiepert, Jr. -------------------------- Name: Donald R. Kiepert, Jr. Title: President, Chief Executive Officer EXHIBIT INDEX The following exhibit is filed herewith: Exhibit Description - ------- ----------- 99.1 Point Therapeutics, Inc. ("Point") issued a press release on June 1, 2006 announcing that the U.S. Food and Drug Administration has granted talabostat Fast Track Designation for the treatment of Stage IIIB/IV non-small cell lung cancer patients who have failed prior platinum-based chemotherapy. EX-99.1 2 a5161109ex991.txt POINT THERAPEUTICS, INC. EXHIBIT 99.1 Exhibit 99.1 Point Therapeutics Receives Fast Track Designation for Talabostat BOSTON--(BUSINESS WIRE)--June 1, 2006--Point Therapeutics, Inc. (NASDAQ: POTP) today announced that the U.S. Food and Drug Administration (FDA) has granted talabostat Fast Track Designation for the treatment of Stage IIIB/IV non-small cell lung cancer (NSCLC) patients who have failed prior platinum-based chemotherapy. "The Fast Track designation is a significant milestone for talabostat and an important step in moving forward with the development process. The designation recognizes the serious unmet medical need of patients with metastatic non-small cell lung cancer who have failed prior platinum-based chemotherapy and the potential of talabostat to impact this disease," said Dr. Margaret Uprichard, Senior Vice President and Chief Scientific Office of Point Therapeutics. "This designation will allow for rolling submission of our potential New Drug Application (NDA) for talabostat--which means that sections of the NDA can be submitted and reviewed by the FDA on an ongoing basis prior to their receipt of the complete NDA." Talabostat's novel dual mechanism of action and positive results from the Phase 2 study combining talabostat with docetaxel (64% second-line patients and 36% third-line patients) were the key components of the application for Fast Track designation in metastatic NSCLC. In the Phase 2 study, 55 patients were enrolled--42 of whom met evaluability criteria for response. Six patients demonstrated a clinical response to treatment as defined by World Health Organization criteria (a 50% or greater reduction in tumor size) for an overall response rate of 14.3%. Two of these patients had a complete response, defined as a complete disappearance of their tumor. In all 55 patients, median progression-free survival is 4.2 months and one year survival is 38%. Under the FDA Modernization Act of 1997, the Fast Track program of the FDA is designed to facilitate the development and expedite the review of a new drug that is intended for the treatment of a serious or a life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition. Under the FDA Guidance, drugs that are granted Fast Track status typically represent a significant improvement in the safety or effectiveness over existing therapies. Point's Phase 3 NSCLC program was initiated in October 2005 and consists of two randomized, double blind placebo controlled trials in up to 800 patients at approximately 100 sites in North America. The first 400-patient trial, evaluating the combination of talabostat with docetaxel versus placebo and docetaxel opened to enrollment in October 2005. The second 400-patient trial, evaluating the combination of talabostat with pemetrexed versus placebo and pemetrexed opened to enrollment in February 2006. The primary study endpoint is progression-free survival. Secondary endpoints include overall survival, objective response rate, duration of response and quality of life. Trial results for both studies are projected for late 2007. About Lung Cancer: According to the American Cancer Society, lung cancer is the leading cause of cancer death among men and women in the United States with nearly 60% of people diagnosed dying within one year and nearly 75% dying within two years. Nearly all lung cancers are non-small cell. While treatment options for NSCLC continue to emerge, mortality rates have not improved in the last 10 years, leaving a significant need for advancement in current therapies. About Point Therapeutics, Inc.: Point is a Boston-based biopharmaceutical company developing a portfolio of dipeptidyl peptidase (DPP) inhibitors for use in cancer, type 2 diabetes and as vaccine adjuvants. Point is currently studying its lead product candidate, talabostat, in two Phase 3 trials in non-small cell lung cancer. Point is also studying talabostat in several Phase 2 trials, including as a single-agent in metastatic melanoma, in combination with cisplatin in metastatic melanoma, in combination with rituximab in advanced chronic lymphocytic leukemia, and in combination with gemcitabine in metastatic pancreatic cancer. In addition, Point's portfolio includes two other DPP inhibitors in preclinical development--PT-630 for type 2 diabetes and PT-510 as a vaccine adjuvant. Certain statements contained herein are not strictly historical and are "forward looking" statements as defined in the Private Securities Litigation Reform Act of 1995. This information includes statements with respect to the company's clinical development programs and the timing of initiation and completion of its clinical trials. Forward-looking statements are statements that are not historical facts, and can be identified by, among other things, the use of forward-looking language, such as "believes," "feels," "expects," "may," "will," "should," "seeks," "plans," "schedules to," "projects," "anticipates" or "intends" or the negative of those terms, or other variations of those terms of comparable language, or by discussions of strategy or intentions. A number of important factors could cause actual results to differ materially from those projected or suggested in the forward looking statement, including the risk factors described in Point's quarterly report on Form 10-Q for the quarter ended March 31, 2006 and from time to time in Point's periodic and other reports filed with the Securities and Exchange Commission. CONTACT: Point Therapeutics, Inc. Sarah Cavanaugh, 617-933-7508 Director, Corporate Communications -----END PRIVACY-ENHANCED MESSAGE-----