Chipscreen Biosciences and HUYA Bioscience Int'l Announce Promising Preclincial and...

Thu Oct 23, 2008 11:59am EDT

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Chipscreen Biosciences and HUYA Bioscience Int'l Announce Promising
Preclincial and Phase I Solid Tumor/Lymphoma Data for Chidamide/HBI-8000, New
HDAC Inhibitor for Cancer
First Compound Sourced from China Shows Strong Results Presented at Cambridge
Healthtech Institute Fall Conference

BOSTON, Oct. 23 /PRNewswire/ -- CHI -- Chipscreen Biosciences (Chipscreen)
and HUYA Bioscience International (HUYA) today described the preclinical
profile and outcome of a Phase I trial with Chidamide/HBI-8000, carried out in
China by Chipscreen Biosciences, Ltd. of Shenzhen. The clinical trial produced
best in class pharmacokinetics (PK), biomarker and safety profiles, and
demonstrated activity against T-lymphoma and other tumor types.
    The compound, known as Chidamide in China and HBI-8000 in the US, is a
novel, benzamide class histone deacetylase (HDAC) inhibitor discovered by
Chipscreen using a computer-aided rationale design approach.
Chidamide/HBI-8000 shows promise for the treatment of a broad range of
cancers. The Phase I trial, which was initiated in China in April 2007,
evaluated safety, PK, biomarker and efficacy profiles in relapsed/refractory
solid tumors and lymphomas.
    "The preclinical data, generated in both China and the US, as well as the
Phase I results are very promising -- demonstrating a best in class profile,"
said Mireille Gingras, PhD, CEO, HUYA Bioscience International. "The data will
enable advancement of Chidamide/HBI-8000 to Phase II/III studies in China and
Phase I in the US, and provides significant validation of our China/US
co-development business model."
    "With this exciting data in humans and continuing research efforts in our
laboratory, we are also starting to understand better the unique properties
and novel molecular mechanisms of action potentially associated with Chidamide
as well as certain subtypes of the HDAC family," said Xian-Ping LU, PhD,
President and Chief Scientific Officer of Chipscreen Biosciences.
    HUYA holds exclusive development and commercialization rights to the
compound worldwide outside of China, while Chipscreen maintains rights in
China. HUYA has previously received positive pre-IND comments from the FDA
Oncology Division for HBI-8000, including its willingness to accept both
preclinical and clinical data generated in China as supportive information for
the opening of a US IND and initiation of a Phase I trial.  Both a Phase
II/III lymphoma trial in China and a Phase I solid tumor/lymphoma trial in the
US are planned for early 2009.
    Preclinical Profile and Clinical Results
    Chidamide/HBI-8000 is an orally bioavailable, low nanomolar inhibitor of
cancer-associated HDACs and is one of the most potent inhibitors in the
benzamide class. It selectively inhibits tumor cell growth, relative to normal
cells, with a therapeutic index of over 20-fold.
    Patients received escalating oral doses of 5 to 50 mg Chidamide/HBI-8000
either two or three times per week for four weeks, followed by a two week
drug-free period for up to six cycles.  PK parameters indicated significant
exposure and this was validated by biomarker activity levels comparable to,
but lasting longer than, most HDAC inhibitors.  Chidamide/HBI-8000 produced
significant activity in this early stage trial, with five out of twenty-five
evaluable subjects experiencing a partial response and eleven with stable
disease.  The only dose-limiting toxicities (DLTs) were gastrointestinal in
nature. Additional DLTs seen with other HDAC inhibitors, such as bone marrow
suppression, fatigue and QTc prolongation were not observed with
Chidamide/HBI-8000, supporting a best in class safety profile.
    Results will be presented by Michael J. Newman, PhD, Executive Vice
President, Oncology, HUYA Bioscience International at the Cambridge Healthtech
Institute's annual conference on HDAC inhibitors, Thursday, October 23.
    About HDACs and HDAC inhibitors
    HDAC inhibitors, a new class of cancer drugs, work by controlling how
tightly DNA is wound around accessory proteins, histones.  By deacetylating
(removing an acetyl group from) histones, HDACs appear to promote tighter
winding of DNA around these proteins, leading to reduced access by gene
transcription factors.  This results in decreased expression of proteins
involved in cell differentiation, cell cycle arrest and apoptotic elimination
of damaged cells -- all of which contribute to the development of cancer.
HDAC inhibitors are able to restore expression of tumor suppressor genes in a
highly selective manner.  Treatment with HDAC inhibitors also leads,
indirectly, to inhibition of the expression of angiogenesis factors, helping
to choke off the blood supply to tumors.
    Although significant preclinical and clinical activity has been observed
with HDAC inhibitors, most have characteristics which may limit their
potential for clinical success or broad applicability.  In contrast,
Chidamide/HBI-8000 has selectivity, potency, PK and side effect profiles that
make it ideal for use as a stand-alone therapeutic, as well as in combination
with a wide variety of marketed anti-tumor agents.
    HUYA's Integrated Co-development Model (ICM)
    The global pharmaceutical industry faces a pressing need for new untapped
sources of pre-clinical and clinical stage compounds for the drug development
process.  HUYA was one of the first companies to recognize China's potential
to help meet this need through its burgeoning biotechnology industry and
world-class talent pool.  HUYA has pioneered an innovative approach -- the
HUYA Integrated Co-development Model -- for partnering with Chinese research
institutions and pharmaceutical companies.  HUYA identifies and licenses the
most promising pre-clinical and clinical stage compounds in China, leverages
and extends the research efforts of its Chinese partners, and provides a
bridge into the Western development process and biopharma market.
    Because the compounds have already been validated through a rigorous
discovery, selection and development process in China, this model streamlines
and accelerates development in the West, while lowering risk.  Moreover, the
strength of HUYA's relationships with its Chinese partners ensures a
continuous source of compounds for the future.
    About HUYA
    HUYA is the leader in US/China pharmaceutical co-development.  With three
strategic offices in China, the broadest Chinese compound portfolio, and more
exclusive agreements with premier Chinese biotech centers than any other
company, HUYA has pioneered the most innovative and productive approach for
pharmaceutical co-development between the US and China.  HUYA has joint
headquarters offices in San Diego, CA, and Shanghai.  Further information
about the company is available at
    About Chipscreen Biosciences
    Chipscreen Biosciences is the leading Chinese biotech company specialized
in the discovery and development of novel small molecule pharmaceuticals. The
company has utilized its proprietary chemical genomics-based discovery
platform to successfully develop a portfolio of clinical and preclinical stage
programs in a number of therapeutic areas. Chipscreen's business strategy is
to generate differentiated drug candidates across multiple therapeutic areas,
then partner at the research, preclinical or early clinical stage for further
co-development and commercialization outside China. Further information about
the company is available at

     HUYA USA:               HUYA China:          Shenzhen Chipscreen
                                                   Biosciences, Ltd.
     Jan Tuttleman, PhD      Ben Ni, PhD
     Vice President,         Head of              Xian-Ping LU, PhD
      Marketing               Therapeutics        President and Chief
     HUYA Bioscience         HUYA Bioscience       Scientific Officer
      International, LLC      International, LLC  Shenzhen Chipscreen
     (858) 798-8800          86 (21) 51323312      Biosciences, Ltd.      86-(755)26711889

     Media Contacts:

     Amy Berry                       Juliet Travis
     (415) 793-2258                  (510) 452-3771 

SOURCE  HUYA Bioscience International; Chipscreen Biosciences

HUYA USA, Jan Tuttleman, PhD, Vice President, Marketing, +1-858-798-8800,, or HUYA China, Ben Ni, PhD, Head of Therapeutics, 86
(21) 51323312,, both of HUYA Bioscience International, LLC; or
Xian-Ping LU, PhD, President and Chief Scientific Officer of Shenzhen
Chipscreen Biosciences, Ltd., 86-(755)26711889,; or media,
Amy Berry, +1-415-793-2258,, or Juliet Travis,
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