SuperGen's MP-470 Demonstrates Clinical Tumor Regression When Combined with Standard...
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SuperGen's MP-470 Demonstrates Clinical Tumor Regression When Combined with
Standard of Care Chemotherapy
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 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 mbeckerich@dorland.com
Tel: (925) 560-0100
Email: tenns@supergen.com
Mary M. Vegh
Manager, Investor Relations
Tel: (925) 560-2845
E-mail: mary.vegh@supergen.com
SOURCE SuperGen, Inc.
Timothy L. Enns, SVP, Corporate Communications & Business Development,
+1-925-560-0100, tenns@supergen.com, or Mary M. Vegh, Manager, Investor
Relations, +1-925-560-2845, mary.vegh@supergen.com, both of SuperGen, Inc.; or
Media, Michael Beckerich of Dorland Global Public Relations for SuperGen,
Inc., +1-212-677-7632, mbeckerich@dorland.com
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