Point Therapeutics Awarded $600,000 Orphan Products Development Grant to fund Company's Current Phase 2 Study of Talabostat and
11 October 2005 - 9:30PM
Business Wire
Point Therapeutics, Inc. (NASDAQ: POTP) announced today that it has
been awarded an Orphan Products Development Grant from the Food and
Drug Administration to fund its Phase 2 study of talabostat in
combination with rituximab in advanced chronic lymphocytic leukemia
(CLL). On September 19, 2005, Point announced that it had achieved
a 20% clinical response rate in the first 20 evaluable patients in
the first stage of the company's Phase 2 CLL study. This was the
targeted response rate needed to continue the study to completion.
The $600,000 grant is a two-year grant funding costs related to the
company's ongoing Phase 2 CLL trial. Orphan Products Development
grants are awarded by the Food and Drug Administration to encourage
clinical development of products for use in rare diseases or
conditions, usually defined as affecting less than 200,000 people
in the United States. CLL is an incurable disease that usually
affects people over 60 years of age. Patients who present with
advanced stage disease or who progress to the state of requiring
treatment have a poor outcome with a median survival of only 18 to
36 months. "We are very pleased to be one of the few corporate
programs to receive an Orphan Products Development Grant this
year," said Don Kiepert, President and CEO of Point Therapeutics,
Inc. "This award, coupled with the positive results we recently
announced, positions Point to complete the Phase 2 CLL trial and
make a Phase 3 go/no-go decision in the first quarter of 2006."
About Point Therapeutics, Inc.: 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. Its lead product candidate, talabostat
(PT-100), is a small molecule drug in Phase 2 clinical trials.
Talabostat is orally-active and, through a novel mechanism of
action, has the potential to inhibit the growth of malignant tumors
and to support the reconstitution of the hematopoietic system. In
2004, Point initiated four Phase 2 clinical trials of talabostat.
The trials are studying talabostat in combination with docetaxel in
metastatic non-small cell lung cancer, talabostat as a single agent
in metastatic melanoma, talabostat in combination with cisplatin in
metastatic melanoma, and talabostat in combination with rituximab
in advanced chronic lymphocytic leukemia. In June of 2005, Point
announced the initiation of a fifth Phase 2 clinical trial studying
talabostat 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 on the prospects
for our drug development activities and results of operations based
on our current expectations, such as statements regarding certain
milestones with respect to our clinical program and our product
candidates. 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," "schedule
to," "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,
but not limited to, the ability of Point to (i) successfully
develop and manufacture products, (ii) obtain external funding to
finance the operations, (iii) obtain the necessary regulatory
approvals, and (iv) obtain and enforce intellectual property
rights, as well as the risk factors described in Point's Quarterly
Report on Form 10-Q filed with the Securities and Exchange
Commission on August 9, 2005 and from time to time in Point's other
reports filed with the Securities and Exchange Commission.
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