INNOVIVE Pharmaceuticals Announces Preliminary Phase I Data of INNO-406 as a Therapeutic for Treatment Resistant or Intolerant C
December 11 2006 - 8:00AM
PR Newswire (US)
Data presented at American Society of Hematology 48th Annual
Meeting NEW YORK, Dec. 11 /PRNewswire-FirstCall/ -- INNOVIVE
Pharmaceuticals, Inc. (OTC:IVPH) (BULLETIN BOARD: IVPH) announced
today positive preliminary data from a Phase I study of INNO-406
for the treatment of Gleevec(R) (imatinib)-resistant or intolerant
chronic myelogenous leukemia (CML). Early evidence of clinical
activity has been demonstrated in Gleevec-resistant and Tasigna(R)
(nilotinib)-intolerant patients using hematologic, cytogenetic, and
molecular measures. Preclinical data showed that 17 out of 18
mutations of the disease associated with Gleevec-resistance are
sensitive to INNO-406, and this preclinical data was demonstrably
predictive of the clinical activity reviewed to date.
Therapeutically active concentrations of INNO-406 have been
achieved in human tissue, and the drug has shown no serious adverse
events or clinically relevant adverse events through the first
three dose cohorts. INNO-406 is well tolerated at 120 mg/day and
the dose escalating study continues in an effort to determine a
recommended Phase II dose. Of the six patients who have completed
at least one month of treatment, three have evidence of clinical
response: * A patient with a chronic phase CML treated with
imatinib for 69 months before developing resistant disease with a
Y253H mutation has a cytogenetic response after one month of
INNO-406 therapy. * A patient with an accelerated phase CML treated
with imatinib and nilotinib for 16 and 6 months respectively,
before becoming intolerant to nilotinib has maintained a complete
hematologic response following three months of INNO-406 therapy at
a dose of 60 mg/day. * A patient with a chronic phase CML treated
with imatinib for 51 months before developing resistant disease
without a mutation has maintained stable white cell counts after 4
months of therapy at a dose of 30-60 mg/day, with a 55-fold
reduction in Bcr-Abl transcript levels after one month of INNO-406
therapy. "INNO-406 is a rationally designed dual Bcr-Abl and Lyn
kinase inhibitor that is 25 to 55 times more potent than Gleevec,"
said Steven Kelly, President and CEO of INNOVIVE Pharmaceuticals.
"INNO-406 has demonstrated activity in numerous Gleevec-resistant
cell lines with greater selectivity than the dual Abl/Src kinase
inhibitor dasatinib. We are encouraged by these early results and
look forward to reporting complete results from this study in the
second quarter of 2007." This Phase I open label intra-patient
dose-escalation study is designed to determine the biologically
active dose, the maximum tolerated dose and dose limiting toxicity
of INNO-406 when administered as a single agent to adult patients
with imatinib-resistant or intolerant Philadelphia chromosome-
positive leukemias. Patients enrolled in the study are treated with
continuous daily oral dosing. Results from this study are expected
to determine the safety profile and tolerability of INNO-406 in
this patient population for the design of a pivotal Phase II study.
About INNO-406 INNO-406 (formerly known as NS-187) is an orally
bioavailable, rationally designed, dual Bcr-Abl and Lyn-kinase
inhibitor currently in Phase I clinical studies. According to a
study published in the journal Blood (Dec. 1, 2005), INNO-406 is 25
to 55 times more potent than imatinib in vitro, and at least 10
times as effective as imatinib mesylate in suppressing the growth
of Bcr-Abl bearing tumors. INNO-406 has demonstrated activity in 12
of 13 imatinib- resistant cell lines. In addition to its Bcr-Abl
inhibitory properties, INNO- 406 inhibits Lyn kinase. Upregulation
of Lyn kinase activity is a well recognized cause of imatinib
resistance. Lyn kinase activation has also been documented in a
variety of solid tumors, including prostate cancer. About INNOVIVE
Pharmaceuticals INNOVIVE Pharmaceuticals, Inc. acquires, develops
and commercializes novel therapeutics addressing significant unmet
medical needs in the fields of oncology and hematology. In addition
to the recently acquired Tamibarotene for acute promyelocytic
leukemia, the company has three drug programs in clinical
development, INNO-406, INNO-206, and INNO-305, for the treatment of
chronic myelogenous leukemia, small cell lung cancer, and acute
myelogenous leukemia respectively. For additional information visit
http://www.innovivepharma.com/. Forward-looking Statements This
material contains forward-looking statements as defined by the
Private Securities Litigation Reform Act of 1995. These include
statements concerning plans, objectives, goals, strategies, future
events or performance and all other statements which are other than
statements of historical fact, including without limitation,
statements containing words such as "believes," "anticipates,"
"expects," "estimates," "projects," "will," "may," "might" and
words of a similar nature. Such statements involve risks and
uncertainties that could cause actual results to differ materially
from those projected. Among other things, there can be no
assurances that any of INNOVIVE's development efforts relating to
its product candidates will be successful. Other risks that may
affect forward-looking information contained in this press release
include the risk that the results of clinical trials may not
support INNOVIVE's claims, the possibility of being unable to
obtain regulatory approval of INNOVIVE's product candidates,
INNOVIVE's reliance on third party researchers to develop its
product candidates and its lack of experience in developing
pharmaceutical products. These and other risks are discussed in
INNOVIVE'S Registration Statement on Form 10 and its periodic
reports filed with the SEC. The forward-looking statements
contained herein represent the judgment of INNOVIVE as of the date
this material was drafted. INNOVIVE disclaims, however, any intent
or obligation to update any forward- looking statements. Gleevec(R)
and Tasigna(R) are registered trademarks of Novartis
Pharmaceuticals Corporation. DATASOURCE: INNOVIVE Pharmaceuticals,
Inc. CONTACT: Steve Kelly, President and CEO of INNOVIVE
Pharmaceuticals, +1- 212-716-1820; or Rachel Lipsitz, Media &
Investor Relations of Porter Novelli Life Sciences,
+1-619-849-5378, for INNOVIVE Pharmaceuticals Web site:
http://www.innovivepharma.com/
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