Point Therapeutics (MM) (NASDAQ:POTP)
Historical Stock Chart
From Jul 2019 to Jul 2024
![Click Here for more Point Therapeutics (MM) Charts. Click Here for more Point Therapeutics (MM) Charts.](/p.php?pid=staticchart&s=N%5EPOTP&p=8&t=15)
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.