SuperGen's MP-470 Demonstrates Clinical Tumor Regression When Combined with Standard of Care Chemotherapy
October 23 2008 - 6:00AM
PR Newswire (US)
DUBLIN, Calif., Oct. 23 /PRNewswire-FirstCall/ -- SuperGen, Inc.
(NASDAQ:SUPG), a pharmaceutical company dedicated to the discovery
and development of novel cancer therapies, today presented data on
MP-470, its lead product candidate, and four additional posters, at
the 20th EORTC-NCI-AACR Symposium on "Molecular Targets and Cancer
Therapeutics" in Geneva, Switzerland. MP-470, an orally
bio-available multi-targeted tyrosine kinase inhibitor, showed
encouraging tumor regression results in the first two arms
(paclitaxel/carboplatin and carboplatin/etoposide) of its current
Phase 1b clinical trial examining MP-470 combined with five
standard of care (SOC) anticancer treatments. "We are extremely
pleased to report a series of important clinical and scientific
advances achieved by our Company," said James S. Manuso, Ph.D.,
SuperGen's President and Chief Executive Officer. "In addition to
MP-470's progress in the clinic, before year-end, we expect to
enter SGI-1776, our PIM kinase inhibitor, into Phase 1 clinical
trials. This will be our second novel drug in clinical
development." In a poster presentation (Abstract #403) entitled,
"Clinical responses of highly refractory solid tumor patients to
oral MP-470, a multi-targeted tyrosine kinase inhibitor, in
combination with standard of care chemotherapy regimens.
Preliminary report from a multi-institutional phase 1b clinical
trial," Dr. A. Tolcher, Director of Clinical Research at START
(South Texas Accelerated Research Therapeutics) in San Antonio,
Texas, highlighted data showing tumor regression in four patients
in the two arms, indicating that MP-470 may sensitize/re-sensitize
tumors to the anticancer effects of SOC regimens of DNA-damaging
agents. Of note, MP-470 did not increase the types or severity of
adverse events. However, a primary endpoint of the trial -
determining the maximum tolerated dose of MP-470 co-administered
with SOC regimens - has not been reached and dose escalation
continues. "These compelling results strengthen the rationale for
combining MP-470 with DNA-damaging agents due to MP-470's purported
ability to suppress the Rad51 DNA repair mechanism, which is
important in various malignancies," said Dr. Gregory Berk,
SuperGen's Chief Medical Officer. "We look forward to presenting
updated results on MP-470 in combination with these platinum
doublets, as well as the other three standard of care arms of the
trial in the future." Earlier this year, U.S. Food and Drug
Administration granted orphan drug designation for MP-470 in the
treatment of glioblastoma multiforme (GBM) after non-clinical
studies showed more than two-fold effect of increased cell death
when used synergistically with ionizing radiation. Orphan drug
designation for GBM, an often fatal form of brain cancer, can
entitle SuperGen to seven years of market exclusivity. SuperGen's
lead product candidate has also shown promise in preclinical
testing across a wide spectrum of cancers, including non-small cell
lung cancer. Furthermore, SuperGen presented four additional
posters at the Symposium that reviewed clinical and non-clinical
advances of the compounds MP-470, SGI-1776 and SGI-1252. These
include: Abstract 332: In vivo activity of SGI-1776, an orally
active PIM kinase inhibitor Abstract 426: Effects of food on the
single-dose pharmacokinetics of oral MP-470 capsules Abstract 480:
MP-470, a novel multi-targeted tyrosine kinase inhibitor targeting
Rad51 is not toxic to human primary marrow stem cells at clinically
relevant concentrations Abstract 571: Modulation of JAK2 signaling
pathways in vitro and in vivo Copies of the 20th EORTC-NCI-AACR
Symposium poster presentations will be available in the pipeline
section of SuperGen's Web site http://www.supergen.com/. About
SuperGen Based in Dublin, Calif., SuperGen, Inc. is a
pharmaceutical company dedicated to the discovery and development
of novel cancer therapies. SuperGen is developing a number of
therapeutic anticancer products focused on kinase and cell
signaling inhibitors and DNA methyltransferase inhibitors. For more
information about SuperGen, please visit http://www.supergen.com/.
Forward-Looking Statements This news release contains certain
"forward-looking" statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements are
typically preceded by words such as "believes," "expects,"
"anticipate," "intends," "will," "may," "should," or similar
expressions. These forward-looking statements are not guarantees of
future performance and involve a number of risks and uncertainties
that may cause actual results to differ materially from the results
discussed in these statements. Factors that might cause the
company's results to differ materially from those expressed or
implied by such forward-looking statements include, but are not
limited to, the ability to discover, develop and move target
compounds into clinical development and other risks and
uncertainties detailed from time to time in the company's filings
with the Securities and Exchange Commission including its most
recently filed Form 10-Q and 10-K. SuperGen, Inc. undertakes no
duty to update any of these forward-looking statements to conform
them to actual results. Contacts: SuperGen, Inc. Dorland Global
Public Relations Timothy L. Enns Michael Beckerich (Media) SVP,
Corporate Communications Tel: (212) 677-7632 & Business
Development Tel: (925) 560-0100 Email: Mary M. Vegh Manager,
Investor Relations Tel: (925) 560-2845 E-mail: DATASOURCE:
SuperGen, Inc. CONTACT: Timothy L. Enns, SVP, Corporate
Communications & Business Development, +1-925-560-0100, , or
Mary M. Vegh, Manager, Investor Relations, +1-925-560-2845, , both
of SuperGen, Inc.; or Media, Michael Beckerich of Dorland Global
Public Relations for SuperGen, Inc., +1-212-677-7632, Web site:
http://www.supergen.com/
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