Gpc Biotech AG ADS (MM) (NASDAQ:GPCB)
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GPC Biotech AG (Frankfurt Stock Exchange: GPC; NASDAQ: GPCB) today
announced that enrollment has opened in a Phase 1 study evaluating
RGB-286638 in patients with advanced solid tumors. This is the first
time that this novel drug candidate is being studied in human clinical
trials.
The Phase 1 trial is an open label study being conducted at Erasmus
University Medical Center, Rotterdam, The Netherlands under the
direction of M.J.A. de Jonge, M.D., Ph.D. The objectives of this study
are to evaluate the safety and tolerability and to determine the maximum
tolerated dose and recommended Phase 2 dose and schedule for RGB-286638
in patients with advanced solid tumors. The trial is expected to enroll
up to approximately 48 patients.
Dr. de Jonge said: “We are pleased to have the opportunity to be the
first site to test RGB-286638 in the clinic. Patients in the advanced
stages of cancer are in urgent need of new treatments. The pre-clinical
profile of RGB-286638 is compelling and justifies clinical testing.”
“We are excited to move RGB-286638 into clinical development,” said
Martine George, M.D., Senior Vice President, Drug Development and Chief
Medical Officer of GPC Biotech. “Dr. de Jonge and her colleagues at
Erasmus University are highly respected for their excellent work in
cancer research, and we are pleased to have the opportunity to work with
them.”
About RGB-286638
RGB-286638 is a multi-targeted protein kinase inhibitor entering Phase 1
clinical testing. The RGB-286638 compound has been shown in cancer cells
to lead to the inhibition of cell cycle progression, the process that
controls cell division and ensures the accurate duplication of genetic
material, by targeting all relevant cyclin-dependent kinases, which are
proteins involved in regulating the cell cycle. RGB-286638 has also been
shown to induce apoptosis (programmed cell death) and to inhibit other
major protein kinases that are important for the proliferation of cancer
cells. In a range of pre-clinical models of solid and hematological
tumors, RGB-286638 treatment results in tumor regression and increased
survival.
About GPC Biotech
GPC Biotech AG is a publicly traded biopharmaceutical company focused on
anticancer drugs. GPC Biotech's lead product candidate is satraplatin,
an oral platinum compound. The Company has various anti-cancer programs
in research and development that leverage its expertise in kinase
inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich
(Germany) and has a wholly owned U.S. subsidiary in Princeton, New
Jersey. For additional information, please visit GPC Biotech's Web site
at www.gpc-biotech.com.
This press release contains forward-looking statements, which express
the current beliefs and expectations of the management of GPC Biotech.
Such statements are based on current expectations and are subject to
risks and uncertainties, many of which are beyond our control, that
could cause future results, performance or achievements to differ
significantly from the results, performance or achievements expressed or
implied by such forward-looking statements. Actual results could differ
materially depending on a number of factors, and we caution investors
not to place undue reliance on the forward-looking statements contained
in this press release. There can be no guarantee that RGB-286638 will be
successfully developed. We direct you to GPC Biotech’s Annual Report on
Form 20-F for the fiscal year ended December 31, 2007 and other reports
filed with the U.S. Securities and Exchange Commission for additional
details on the important factors that may affect the future results,
performance and achievements of GPC Biotech. Forward-looking statements
speak only as of the date on which they are made and GPC Biotech
undertakes no obligation to update these forward-looking statements,
even if new information becomes available in the future.