Kosan Initiates Phase 2 Trial of Epothilone KOS-1584 in Non-Small Cell Lung Cancer
14 Avril 2008 - 1:00PM
PR Newswire (US)
HAYWARD, Calif., April 14 /PRNewswire-FirstCall/ -- Kosan
Biosciences Incorporated (NASDAQ:KOSN) today announced that the
Phase 2 trial of epothilone KOS-1584 in patients with non-small
cell lung cancer has been initiated. The Phase 2 trial is an
open-label, multi-center, monotherapy study of KOS-1584 in patients
with measurable advanced or metastatic non-small cell lung cancer
who have previously received only one prior chemotherapy regimen.
The primary endpoint of the Phase 2 trial is objective response
rate. Secondary endpoints include progression-free survival, time
to progression, time to treatment failure, time to response,
duration of response and overall survival. KOS-1584 will be
administered via a 3-hour intravenous infusion weekly for two weeks
out of every three weeks at a dose of 25 mg/m(2). The Phase 2 trial
will enroll up to 50 patients in a two-stage Simon design. "We have
been impressed by the breadth and level of activity and
tolerability we have observed with KOS-1584 in our Phase 1 trials
and believe that KOS-1584 has competitive potential in the emerging
epothilone class of anticancer agents," said Helen S. Kim, Kosan's
President and Chief Executive Officer. "Kosan's epothilone strategy
is to advance KOS-1584 to its next inflection point while seeking a
corporate partner to conduct a registration program and advance our
preclinical product candidate, KOS-1803, into clinical development.
We believe that KOS-1584's therapeutic profile and potential for
near-term commercialization enhance its value for potential
pharmaceutical collaborators." KOS-1584 is a member of a class of
cytotoxic macrolides (epothilones) capable of causing mitotic
arrest by polymerization of cellular microtubules. Since
microtubules are essential for mitosis, motility, secretion and
proliferation, the observed antitumor effects of epothilones have
been attributed to their ability to initiate cell death by
inhibiting such processes. KOS-1584 has demonstrated in vitro
cytotoxicity, more potent or equipotent to that of Taxol(R)
(paclitaxel) in a panel of human cell lines. KOS-1584 has shown
significant antitumor activity in a range of xenograft models,
including non-small cell lung cancer models resistant to paclitaxel
and those expressing multidrug resistance. A long elimination
half-life was seen in Phase I trials. KOS-1584 has demonstrated
antitumor activity and favorable tolerability in Phase 1 trials in
patients with solid tumors, including substantial tumor shrinkage
measured by objective responses in non-small cell lung, ovarian and
pancreatic cancers, as well as durable stable disease in many
additional tumors. 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 a Phase 2
clinical trial in patients with non-small cell lung cancer. 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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