Allos Therapeutics Licenses New Cancer Compound
16 Décembre 2004 - 2:00PM
PR Newswire (US)
Allos Therapeutics Licenses New Cancer Compound WESTMINSTER, Colo.,
Dec. 16 /PRNewswire-FirstCall/ -- Allos Therapeutics, Inc.
(NASDAQ:ALTH) today announced that it has acquired an exclusive
worldwide license from the University of Colorado Health Sciences
Center, the University of Salford and Cancer Research Technology to
develop and commercialize a new chemotherapeutic agent known as
RH1. The compound is currently being investigated in a Phase 1
clinical trial sponsored by Cancer Research UK, the largest
volunteer-supported cancer research organization in the world. RH1
is a targeted cytotoxic prodrug that is bioactivated by the enzyme
DT-diaphorase (DTD), which is over-expressed in many tumors
relative to normal tissue, including lung, colon, breast and liver
tumors. The drug exhibits a similar mechanism of action to the
potent chemotherapeutic agent Mitomycin C, with greater potential
activity against cells expressing high DTD and a potentially more
favorable safety profile. RH1 was a nominated compound for
advancement in the National Cancer Institute's Developmental
Therapeutics Program (DTP), which provides cancer drug discovery
and development resources to the intramural, academic and
industrial research communities. "Pre-clinical work has shown RH1
to be a more efficient substrate for DTD than currently available
agents," said Dr. David Ross, Professor of Toxicology and Chairman,
Dept. of Pharmaceutical Sciences at the University of Colorado.
"This drug may offer a means to selectively target tumors
expressing high levels of DTD." RH1 is currently being evaluated in
patients with advanced solid tumors refractory to other
chemotherapy regimens in an open label, Phase 1 dose escalation
study chaired by Dr. Malcolm Ranson, Director Derek Crowther Unit,
Christie Hospital, Manchester, UK. Up to 40 patients will be
enrolled to test the safety, tolerability and pharmacokinetics (PK)
of escalating doses of RH1. Patient DTD enzyme levels are being
measured to correlate with drug efficacy. Recruitment began in
September 2003 and is expected to complete in the second half of
2005. "We've enrolled nearly a third of the desired number of
patients for the study and are encouraged by results seen to date
from both a safety and efficacy standpoint," said Dr. Ranson. Under
the terms of the agreement, Allos will make an up-front payment and
a series of milestone payments based upon the achievement of
specified development, regulatory and commercialization goals.
Allos will also make royalty payments based on product sales, if
any, resulting from the collaboration. Cancer Research UK will
continue to support the ongoing Phase 1 dose escalation study, and
Allos will have the right to obtain an exclusive license to the
results of the study, for use in subsequent development and
regulatory activities, upon payment of a one-time data option fee.
Upon completion of the Phase 1 study, Allos will assume
responsibility for all further development costs and activities.
Financial terms of the transaction were not disclosed. However,
Allos does not expect the in- licensing of RH1 to result in a
material increase in its quarterly operating expenses for at least
the next 18-24 months. "We're excited to add this novel compound to
our growing oncology portfolio," said Michael E. Hart, President
and Chief Executive Officer of Allos. "RH1 complements our current
development programs and will allow us to capitalize on our
in-house clinical, regulatory and manufacturing expertise." About
Allos Therapeutics, Inc. Allos Therapeutics, Inc. is a
biopharmaceutical company focused on developing and commercializing
innovative drugs for improving cancer treatments. The company's
lead clinical candidate, EFAPROXYN(TM) (efaproxiral), is a
synthetic small molecule that has the potential to sensitize
hypoxic (oxygen deprived) tumor tissues and enhance the efficacy of
standard radiation therapy. In addition, Allos is developing PDX
(pralatrexate), a novel small molecule cytoxic injectable
antifolate (DHFR inhibitor) intended to treat non-small cell lung
cancer, mesothelioma and non-Hodgkin's lymphoma. For more
information, please visit the company's web site at:
http://www.allos.com/. Safe Harbor Statement This press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995. Such forward-looking statements include statements
concerning the potential safety and efficacy profile of RH1; the
projected enrollment and timeline for completion of the ongoing
Phase 1 dose escalation study; the projected impact of RH1 on the
Company's quarterly operating expenses; and other statements that
are other than statements of historical facts. In some cases, you
can identify forward-looking statements by terminology such as
"may," "will," "should," "expects," "intends," "plans,"
anticipates," "believes," "estimates," "predicts," "projects,"
"potential," "continue," and other similar terminology or the
negative of these terms, but their absence does not mean that a
particular statement is not forward- looking. Such forward-looking
statements are not guarantees of future performance and are subject
to risks and uncertainties that may cause actual results to differ
materially from those anticipated by the forward-looking
statements. These risks and uncertainties include, among others:
that clinical trials may not demonstrate that RH1 is both safe and
more effective than current standards of care; that the Company may
be unable obtain the regulatory approvals necessary to conduct
additional clinical trials; that the Company and/or its
collaborators may not be able to enroll sufficient numbers of
patients in their clinical trials; that data from preclinical
studies and clinical trials may not necessarily be indicative of
future clinical trial results; that the safety and/or efficacy
results of clinical trials for RH1 will not support an application
for marketing approval in the United States or any other country;
and the risk that the Company may lack the financial resources and
access to capital to fund future clinical trials for RH1 or any of
its other product candidates. Additional information concerning
these and other factors that may cause actual results to differ
materially from those anticipated in the forward-looking statements
is contained in the "Risk Factors" section of the Company's Annual
Report on Form 10-K for the year ended December 31, 2003, as
amended, and in the Company's other periodic reports and filings
with the Securities and Exchange Commission, including its
Quarterly Report on Form 10-Q for the quarter ended September 30,
2004. The Company cautions investors not to place undue reliance on
the forward-looking statements contained in this press release. All
forward-looking statements are based on information currently
available to the Company on the date hereof, and the Company
undertakes no obligation to revise or update these forward-looking
statements to reflect events or circumstances after the date of
this presentation, except as required by law. Note: EFAPROXYN(TM)
and the Allos logo are trademarks of Allos Therapeutics, Inc.
DATASOURCE: Allos Therapeutics, Inc. CONTACT: Jennifer Neiman,
Manager, Corporate Communications of Allos Therapeutics, Inc.,
+1-720-540-5227, Web site: http://www.allos.com/
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