Callisto Pharmaceuticals,
Inc. (Amex: KAL; Frankfurt: CA4), a developer of new drug treatments in the
fight against cancer and other major health threats, announced today the
opening of a multi-center, open-label, dose-escalation Phase I clinical
trial of L-Annamycin in children and young adults with refractory or
relapsed acute lymphocytic leukemia (ALL) or acute myelogenous leukemia
(AML) at Phoenix Children's Hospital, Phoenix, AZ, and the University of
Arizona, Tucson, AZ. The Principal Investigator at Phoenix Children's
Hospital is Jessica Boklan, MD, Director of Oncology Research. The
Principal Investigator at the University of Arizona is Rochelle Bagatell,
MD.
The trial utilizes POETIC (Pediatric Oncology Experimental Therapeutics
Investigators Consortium), a consortium of prestigious pediatric cancer
centers that focuses on early clinical development of promising therapies
for the treatment of children, adolescents and young adults with cancer.
This ten-member group includes Phoenix Children's, Children's Healthcare of
Atlanta, Johns Hopkins Kimmel Cancer Center, MD Anderson Cancer Center,
Memorial Sloan-Kettering Cancer Center, University of Florida Health
Science Center, University of Colorado - Denver Children's, University of
Arizona, University of Calgary, University of Florida and Vanderbilt
Medical Center. Other member institutions of POETIC are currently reviewing
the trial protocol, and the Company anticipates that additional sites will
open in the very near future.
The primary objectives of the Phase I clinical trial are: 1) to
evaluate safety and identify the maximum tolerated dose (MTD) of
L-Annamycin, starting at 130 mg/m2/day, given over three consecutive days,
and escalating in sequential cohorts until an MTD is reached, and 2) to
evaluate the antileukemia activity of L-Annamycin in children and young
adults with refractory or relapsed ALL or AML. The secondary objective is
to measure the pharmacokinetics of annamycin and its metabolite,
annamycinol. L-Annamycin is administered by infusion using a unique
patented liposomal formulation. Further details of this trial can be found
at clinicaltrials.
"We are particularly interested in exploring the potential of
L-Annamycin to treat children and young adults with acute leukemia," notes
Dr. Gary S. Jacob, Chief Executive Officer of Callisto. "L-Annamycin is
presently in a Phase I clinical trial in adult relapsed or refractory ALL
patients, and we have gained important experience with this drug in the
adult setting that we hope to apply to the pediatric trial."
About L-Annamycin
L-Annamycin, a drug from the anthracycline family originally developed
by scientists at the M.D. Anderson Cancer Center to address the clinical
limitations associated with anthracycline drugs is presently in a Phase I
clinical trial in adult relapsed or refractory ALL patients at three
clinical sites in the US. In animal and in-vivo studies, L-Annamycin
circumvents multi-drug resistance and shows decreased cardiotoxicity. An
earlier Phase I clinical trial of L-Annamycin in relapsed or refractory
acute leukemia patients, performed by a previous sponsor, suggested
potential to treat this disease and was the basis for the initiation by
Callisto in December, 2005 of a Phase I clinical trial of L-Annamcyin in
adult relapsed or refractory ALL patients. In June, 2005, L-Annamycin was
given orphan drug designation to treat both ALL and AML by the FDA.
About Pediatric Acute Leukemia
Pediatric leukemia is the most prevalent cancer among children up to
the age of 19 in the U.S. Approximately 3200-3500 new cases of leukemia in
children and adolescents were diagnosed in the U.S. in 2006, with ALL
accounting for approximately 75% of these new cases, AML for approximately
20% and CML less than 5% of new cases. Notably, survival rates in children
have improved significantly in the last decade but there are a significant
percentage, approximately 20% of ALL and 50% of AML patients who do not
remain in remission and require further treatment. Patients with relapsed
or refractory acute leukemia who have prior treatment with approved
chemotherapeutics generally have a poor prognosis at this point in the
disease and are in need of new agents.
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 in pre-clinical
development for other significant health care markets, including ulcerative
colitis. One of the Company's lead drug candidates, Atiprimod, is in
development to treat advanced carcinoid cancer, a neuroendocrine tumor, and
relapsed multiple myeloma, a blood cancer. Atiprimod is presently in a
Phase II clinical trial in advanced carcinoid cancer patients, and in Phase
I/IIa human clinical trials in relapsed or refractory multiple myeloma
patients, and advanced cancer patients, respectively. Another anti-cancer
drug, L-Annamycin, is being developed as a treatment for forms of relapsed
or refractory acute leukemia, a currently incurable blood cancer. Callisto
initiated a clinical trial of L- Annamycin in adult relapsed or refractory
acute lymphoblastic 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. Callisto also has drugs in
preclinical development for gastro-intestinal inflammation, and cancer.
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. Callisto is also listed on the Frankfurt Stock
Exchange under the ticker symbol CA4. More information is available at
callistopharma.
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 Form S-3/A declared effective on
February 15, 2007 and its 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.
Callisto Pharmaceuticals, Inc.
callistopharma