Positive Phase I/II Results from Pancreatic Cancer Study Announced by Bioaccelerate Holdings Inc. and Australian Cancer Technolo
09 February 2005 - 10:21AM
PR Newswire (US)
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 anti�tumor 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/
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