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FOR
IMMEDIATE RELEASE
February
28, 2006.
Atiprimod
Clinical Trial in Advanced Cancer Patients Uncovers Clear Response
Against Carcinoid Tumors.
Company
Plans New Clinical Trial, New Results May Accelerate Atiprimod's
Path to Approval
NEW YORK--(BUSINESS WIRE)—Feb. 28, 2006--Callisto Pharmaceuticals,
Inc. (AMEX:KAL - News; FWB:CA4), a developer of new drug treatments
in the fight against cancer and other major health threats, today
announced plans to launch an additional indication for clinical
development of its drug candidate Atiprimod based on encouraging
clinical results that showed a clear response in a patient with
advanced carcinoid cancer plus additional encouraging clinical data
on other carcinoid patients.
The
encouraging data provides an additional development path for Atiprimod
that has the potential to give Callisto its first approved drug
considerably earlier than the Company previously expected.
Based
on these new clinical data, the Company announced its commitment
to initiate a new Phase I/II clinical trial of Atiprimod in carcinoid
cancer patients with advanced tumors that it plans to open at several
new sites in the next few months.
Callisto
believes there exists an “unmet medical need” for new treatments
for advanced and metastatic carcinoid tumors because there are no
FDA approved drugs for these types of tumors.
Carcinoid
tumors, or carcinoids, originate in hormone-producing cells of the
gastrointestinal (GI) tract, the respiratory tract, the hepatobiliary
(liver) system and the reproductive glands. The most common site
of origin is the GI tract, with tumors often developing in the rectum,
and other sections of the small intestine.
“The
exciting results from the Phase I/IIa trial of Atiprimod in advanced
cancer patients have transformed our Atiprimod development program,”
said Dr. Gary S. Jacob, CEO of Callisto. “The study uncovered a
patient population with carcinoid tumors that could potentially
benefit from our drug, and our intention is to move aggressively
forward with further clinical evaluation of Atiprimod in a larger
population of carcinoid patients.”
In
particular, Atiprimod may provide new hope for patients with advanced
carcinoid tumors of the liver and GI tract. Common sites of carcinoid
metastases include liver, lungs, bone and lymph nodes. Carcinoid
tumors that metastasize to the liver have a poor prognosis. Traditionally,
chemotherapy relieves symptoms in less than 30% of cases of metastatic
carcinoid tumors, usually for less than 1 year.
“Atiprimod
is a drug that we know from tissue distribution studies accumulates
at highest concentrations in liver and the gastrointestinal tract,”
noted Dr. Donald Picker, Executive VP of Research & Development.
“Because of this response, we are now focusing on a range of other
liver cancers and other metastatic diseases in addition to carcinoids.
We are very excited to initiate a formal separate carcinoid clinical
trial for this serious disease, where there are no currently approved
drugs for these liver metastatic patients.”
The
earlier Atiprimod trial in advanced cancer patients at the University
of Texas M. D. Anderson Cancer Center entitled: “An Open Label Study
of the Safety and Efficacy of Atiprimod Treatment for Patients with
Advanced Cancer” which was begun in March, 2005, originally was
designed to assess Atiprimod’s activity in solid tumors and hematologic
malignancies.
About
Callisto Pharmaceuticals, Inc.
Callisto is a biopharmaceutical company focused on the development
of new drugs to treat various forms of cancer and other serious
afflictions. Callisto's drug candidates in development currently
include anti-cancer agents in clinical development, in addition
to drugs for a range of other significant health care market segments,
including biodefense. One of the Company's lead drug candidates,
L-Annamycin, is being developed as a treatment for forms of relapsed
leukemia, a currently incurable blood cancer. Callisto initiated
a clinical trial of L-Annamycin in adult relapsed acute lymphocytic
leukemia patients in 4Q 2005. L-Annamycin, a new compound from the
anthracycline family of proven anti-cancer drugs, has a novel therapeutic
profile, including activity against resistant diseases and significantly
reduced cardiotoxicity, or damage to the heart, compared to currently
available drug alternatives. Another anti-cancer drug, Atiprimod,
is in development to treat relapsed multiple myeloma, a blood cancer.
Atiprimod has entered Phase I/IIa human clinical trials in relapsed
multiple myeloma patients. Callisto also has drugs in preclinical
development for gastro-intestinal inflammation, and a program focused
on the development of a drug to protect against Staphylococcus and
Streptococcus biowarfare agents. Callisto has exclusive worldwide
licenses from AnorMED Inc. and M.D. Anderson Cancer Center to develop,
manufacture, use and sell Atiprimod and L-Annamycin, respectively.
For
investor-specific information about Callisto, including recent news
and stock price data, please visit http://www.trilogy-capital.com/tcp/callisto/.
For
an Investor Fact Sheet about Callisto, please visit http://www.trilogy-capital.com/tcp/callisto/factsheet.html.
To
view an informational presentation of the Company's development
pipeline of drug candidates, visit http://www.trilogy-capital.com/tcp/callisto/powerpoint.html.
Callisto
is also listed on the Frankfurt Stock Exchange under the ticker
symbol CA4. For additional information, visit www.callistopharma.com.
Forward-Looking
Statements
Certain statements made in this press release are forward-looking.
Such statements are indicated by words such as "expect,"
"should," "anticipate" and similar words indicating
uncertainty in facts and figures. Although Callisto believes that
the expectations reflected in such forward-looking statements are
reasonable, it can give no assurance that such expectations reflected
in such forward-looking statements will prove to be correct. As
discussed in the Callisto Pharmaceuticals Annual Report on Form
10-K/A for the year ended December 31, 2004, and other periodic
reports, as filed with the Securities and Exchange Commission, actual
results could differ materially from those projected in the forward-looking
statements as a result of the following factors, among others: uncertainties
associated with product development, the risk that products that
appeared promising in early clinical trials do not demonstrate efficacy
in larger-scale clinical trials, the risk that Callisto will not
obtain approval to market its products, the risks associated with
dependence upon key personnel and the need for additional financing.
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