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Positive Phase I/II Results from Pancreatic Cancer Study
Announced by Bioaccelerate Holdings Inc. and Australian Cancer Technology
Data Show Doubling of Mean Survival Time in Patients with Pancreatic Cancer
Using RP101 with Chemotherapy Treatment
NEW YORK, Feb. 8 /PRNewswire-FirstCall/ -- Bioaccelerate Holdings Inc.
(BACL.OB) and Australian Cancer Technology (AustCancer) (ASX:ACU), today
announced results from an extended Phase I/II clinical study evaluating RP101
in combination with gemcitabine plus cisplatin for the treatment of metastatic
pancreatic cancer. RP101 (bromovinyl deoxyuridine, or BVDU) is targeted at
preventing cells from developing a resistance to chemotherapy. Bioaccelerate
and AustCancer acquired the North American rights to RP101 from ResProtect GmbH
in September 2004.
In an extended Phase I/II clinical study conducted by ResProtect in Germany, 13
patients with metastasized pancreatic cancer were treated with RP101 and
gemcitabine plus cisplatin. Of the patients treated, nine had stage IV disease
and four had stage III disease. Per treatment cycle, patients were given 125mg
of RP101 four times per day for the first five days of treatment. The treatment
was repeated ten days later. The regimen was repeated for up to six treatment
cycles (1-6). For the treatment group, the 50% probability of survival was
increased to an average of 15 months from an historic average of 7.5 months
(p=0.008). The historical control was developed using a separate study of 15
patients with stage IV disease and 7 with stage III treated with gemcitabine
and cisplatin (Heinemann et al., ASCO 2003, University Munchen). Ten out of the
13 patients lived or live longer than one year, and six of them are still
alive. Additionally, time to tumor progression was increased to 7.5 months
versus 4.75 months as seen in the Heinemann control group.
"The results of this study are encouraging and we are excited to be developing
this promising drug candidate for the treatment of pancreatic cancer. We
believe that RP101 can be useful in expanding the therapeutic window for
chemotherapy, possibly extending survival while also improving the quality of
life for pancreatic cancer patients," stated Dr. Nigel Rulewski, Senior Vice
President of Bioaccelerate Holdings Inc. "Our partnership with AustCancer
further confirms our commitment to developing products that address
significant, underserved medical needs while simultaneously building value
through investment in the early development of exciting technologies."
According to The American Cancer Society, about one out of four patients with
cancer of the exocrine pancreas will live at least one year after the cancer is
found. In the RP101 study, 10 out of 13 patients lived longer than one year.
The group predicts that, in 2005, about 32,180 people in the U.S. will be
diagnosed with pancreatic cancer and about 31,800 will die of the disease.
Patients undergoing repeated chemotherapy treatment can build a resistance to
the chemotherapy's intended toxic effects and cancer cells continue to grow and
spread during treatment. RP101 is intended as a co-treatment with cytostatic
drugs to prevent the development of chemotherapy resistance, often noted as a
significant challenge for oncologists. In preclinical studies, co- treatment of
chemotherapy with RP101 prevented the decrease of apoptotic effects during the
course of chemotherapy and reduced non-specific toxicity. In several different
in vivo tumor models, the antitumor efficacy of chemotherapy was optimized,
and toxic side effects were reduced.
In pancreas carcinoma cells, the oncogene STAT3 is over-expressed leading to
the suppression of apoptotic (programmed cell death) responses. Additionally,
treatment with gemcitabine leads to the over-expression of the DNA-repair gene
APEX, commonly implicated in chemoresistance. RP101 has been shown to
down-regulate STAT3 and APEX, in different tumor cell lines.
About Bioaccelerate Holdings Inc.
Bioaccelerate Holdings Inc. is a pharmaceutical development organization that
seeks to acquire, develop and commercialize novel pharmaceutical compounds in
an efficient, cost-effective way. Bioaccelerate uses its broad network of
academic, industry and capital market relationships to expedite drug
development and raise capital to create and fund its subsidiary companies,
which are organized by vertical portfolios in five therapeutic areas: oncology,
specialty pharmaceuticals, central nervous system disorders (CNS),
cardiovascular disease and anti-infectives.
Bioaccelerate conducts its business directly and through its subsidiaries. The
company holds majority equity interests in ten biopharmaceutical companies,
three of which are public and holds minority interests in four
biopharmaceutical companies, two of which are public. The company also holds a
minority equity interest in a public nanotechnology company. Bioaccelerate
strategy relies on its development network for research, clinical development
and project management to guide early-stage compounds from the discovery
process through to Phase II/III development where incremental value can be
created. Bioaccelerate Holdings is quoted on the Over-The-Counter Bulletin
Board under the symbol "BACL.OB". For more information on Bioaccelerate, visit
the company's website at http://www.bioaccelerate.com/ .
Bioaccelerate Safe Harbor Statement
Certain statements contained herein are "forward-looking" statements (as such
term is defined in the Private Securities Litigation Reform Act of 1995).
Because these statements include risks and uncertainties, actual results may
differ materially from those expressed or implied by such forward-looking
statements. Specifically, factors that could cause actual results to differ
materially from those expressed or implied by such forward-looking statements
include, but are not limited to: risks associated with pre-clinical and
clinical developments in the biopharmaceutical industry in general and in
Bioaccelerate's compounds under development in particular; the potential
failure of Bioaccelerate's compounds under development to prove safe and
effective for treatment of disease; uncertainties inherent in the early stage
of Bioaccelerate's compounds under development; failure to successfully
implement or complete clinical trials; failure to receive marketing clearance
from regulatory agencies for our compounds under development; acquisitions,
divestitures, mergers, licenses or strategic initiatives that change
Bioaccelerate's business, structure or projections; the development of
competing products; uncertainties related to Bioaccelerate's dependence on
third parties and partners. Bioaccelerate disclaims any obligation to update
these forward-looking statements.
About Australian Cancer Technology (http://www.austcancer.com.au/ )
Australian Cancer Technology (AustCancer) is an international biotechnology
company developing a broad oncology-related product portfolio. Austcancer has
acquired the North American marketing rights for RP101, a promising pancreatic
cancer drug currently in Phase II clinical studies through a subsidiary
company, Resistys Inc, a joint venture with Bioaccelerate of New York.
AustCancer's Pentrys(TM) anti-cancer vaccine is being evaluated in prostate
cancer patients in Phase IIb clinical studies and the company is advancing
immune enhancing adjuvants in three Phase I cancer trials. The company also
markets revisys(TM), a branded line of medical nutritionals designed for people
with special needs, including those undergoing cancer treatments. AustCancer is
traded on the Australian Stock Exchange (ASX) under the symbol ACU. The company
has established a Level 1 ADR stock program in the U.S. trading under the
symbol AUCJY and also is listed on the Xetra exchange, the electronic trading
system of the Frankfurt Stock Exchange, trading under the symbol CBS.
CONTACT:
Christopher O'Toole
Senior Vice President
Bioaccelerate Holdings Inc.
212-897-6849
or:
Matthew D. Haines
Vice President
Noonan Russo (Investor and Media Relations)
212-845-4235
DATASOURCE: Bioaccelerate Holdings Inc.
CONTACT: Christopher O'Toole, Senior Vice President, Bioaccelerate
Holdings Inc., +1-212-897-6849; Matthew D. Haines, Vice President, Noonan
Russo (Investor and Media Relations), +1-212-845-4235
Web site: http://www.bioaccelerate.com/
http://www.austcancer.com.au/