Kosan Presents Preclinical Data on Nuclear Export Inhibitors, Novel Anticancer Agents, at AACR
16 Abril 2008 - 4:06PM
PR Newswire (US)
HAYWARD, Calif., April 16 /PRNewswire-FirstCall/ -- Kosan
Biosciences Incorporated (NASDAQ:KOSN) presented preclinical data
on its proprietary nuclear export inhibitors (NEI) showing potent
in vitro and in vivo activity as well as tolerability in leukemia
xenograft models, and further elucidating the NEI anticancer
mechanism of action correlating inhibition of the target CRM1 with
induction of apoptosis selectively in cancer cells compared to
normal cells. Data on Kosan's NEIs were presented at the 2008
Annual Meeting of the American Association for Cancer Research
(AACR), being held in San Diego, CA. Kosan's NEIs are potent,
specific inhibitors of CRM1, a highly conserved, essential protein
that exports key regulatory proteins ("cargo" proteins) from the
nucleus to the cytoplasm. Many cargo proteins that depend on CRM1
for nuclear export, such as p53, Bcr-Abl and FOXO-3a, function as
tumor suppressors or transcription factors that protect normal
cells by regulating cell growth and apoptosis (cell death).
Accumulation of these CRM1 cargo proteins in the nucleus, by
blocking nuclear export, leads to the inhibition of cell growth and
apoptosis selectively in cancer cells. Kosan's polyketide-based NEI
compounds have optimized pharmaceutical properties, including
potency, durability of action and a wide therapeutic index.
"Kosan's NEI preclinical compounds continue to demonstrate
attractive biological and pharmacological properties and potent
anticancer activity and tolerability in both solid and liquid
tumors," said Helen S. Kim, Kosan's President and Chief Executive
Officer. "We are currently seeking a development partner for our
NEI program, as we believe that the optimal strategy for continuing
to explore the therapeutic utility of these unique compounds is
with an oncology collaborator committed to initiating an NEI
clinical program in the near-term." Abstract 1591: "Mechanistic
Analyses of the Therapeutic Activity of Nuclear Export Inhibitors
(NEIs) in Cancer" presented data demonstrating a direct correlation
between target (CRM1) occupancy and the downstream consequences of
CRM1 inhibition, including nuclear export inhibition and
cytotoxicity. Exposure of NEIs to cancer cell lines with normal
(wild-type) p53 results in upregulation of p53, while only a
transient upregulation of p53 is observed in normal cells exposed
to NEIs. In cancer cell lines harboring PTEN mutations, NEI-induced
nuclear entrapment of FOXO, which is regulated by the PTEN/PI3K/Akt
pathway, is directly linked to the induction of apoptosis. NEIs
induce apoptosis in tumor derived cell lines but not in normal
cells, further confirming the hypothesis of the novel, potent and
selective anticancer activity of NEIs. Abstract 5688: "Anti-Tumor
Activity of Novel Nuclear Export Inhibitors (NEIs) in Multiple
Murine Leukemia Models" presented data from NEI compounds tested in
murine models of leukemia, including acute lymphoblastic leukemia
(ALL) and acute myelogenous leukemia (AML) models. KOS-2464,
Kosan's lead preclinical NEI compound induced marked and durable
antitumor responses, including a doubling of survival in an
orthotopic ALL model. KOS-2464 was well-tolerated at efficacious
doses in all of the leukemia models tested. About Kosan Kosan
Biosciences is a biotechnology company advancing two new classes of
anticancer agents through clinical development -- a Hsp90 (heat
shock protein 90) inhibitor and an epothilone. Hsp90 inhibitors
have a novel mechanism of action targeting multiple pathways
involved in cancer cell growth and survival. Tanespimycin (KOS-953)
is being tested in combination with Velcade(R) (bortezomib) in
patients with multiple myeloma in a clinical program called TIME.
Tanespimycin is also being studied in HER2-positive metastatic
breast cancer in combination with Herceptin(R) (trastuzumab).
Epothilones inhibit cell division with a mechanism of action
similar to taxanes, one of the most successful classes of
anti-tumor agents. KOS-1584 is in Phase 1 clinical trials in
patients with solid tumors. Kosan's motilin agonist compound,
KOS-2187, licensed to Pfizer for development in gastroesophagel
reflux disease, is in a Phase 1 trial. For additional information
on Kosan Biosciences, please visit the company's website at
http://www.kosan.com/. This press release contains forward-looking
statements within the meaning of the "safe harbor" provisions of
the Private Securities Litigation Reform Act of 1995 (the "Act").
Such forward-looking statements include but are not limited to
statements regarding the further development and potential safety,
efficacy, regulatory status, commercial potential and other
characteristics of Kosan's product candidates; the continuation of
current clinical trials; the initiation of additional clinical
trials and the timing thereof and the use of Kosan's financial
resources. Words such as "will," "expect," "believe," "may,"
"intend," "plan," "potential" and similar expressions are intended
to identify forward-looking statements. Any statements contained in
this press release that are not statements of historical fact may
be deemed to be forward-looking statements. These forward-looking
statements are based upon Kosan's current expectations.
Forward-looking statements involve risks and uncertainties. Kosan's
actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a
result of these risks and uncertainties, which include, without
limitation, risks related to the uncertain progress and results of
Kosan's preclinical and clinical testing, including the risks that
studies and trials may not demonstrate safety and efficacy
sufficient to initiate clinical trials on the timing currently
anticipated, or at all, continue clinical development, obtain the
requisite regulatory approvals or result in a marketable product;
the conduct of clinical trials; manufacturing; regulatory approval
requirements and process; the effort and expense necessary for
further development of Kosan's product candidates, including the
costs of bortezomib; intellectual property matters, including
Kosan's ability to obtain valid and enforceable patents covering
its product candidates; Kosan's dependence on its collaboration
with Pfizer for development of its motilin agonist product
candidate; Kosan's need for additional financing and Kosan's
strategy to enter into partnering or licensing arrangements. These
and other risk factors are discussed under "Risk Factors" in
Kosan's Annual Report on Form 10-K for the year ended December 31,
2007 and other periodic filings with the SEC. Kosan expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein. Velcade(R) (bortezomib) is a registered trademark of
Millennium Pharmaceuticals, Inc. Herceptin(R) (trastuzumab) is a
registered trademark of Genentech, Inc. DATASOURCE: Kosan
Biosciences Incorporated CONTACT: Jane Green, VP, Corporate
Communications of Kosan Biosciences Incorporated, +1-510-731-5335,
mobile, +1-415-652-4819, Web site: http://www.kosan.com/
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