Callisto CEO Dr. Gary S. Jacob Releases Letter to Shareholders; CEO Affirms Commitment to Continued Aggressive Development of Clinical Programs with Atiprimod and L-Annamycin Anti-cancer Agents.NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- Callisto Pharmaceuticals, Inc. (AMEX AMEX See: American Stock Exchange :KAL) (FWB (Fixed Wireless Broadband) See fixed wireless. :CA4), a developer of new drug treatments in the fight against cancer and other major health threats, today released a letter to shareholders from CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Dr. Gary S. Jacob Jacob (jā`kəb), in the Bible, ancestor of the Hebrews, the younger of Isaac and Rebecca's twin sons; the older was Esau. In exchange for a bowl of lentil soup, Jacob obtained Esau's birthright and, with his mother's help, received the blessing . In the letter, Dr. Jacob outlines the Company's significant business accomplishments during the first quarter of 2006 and cites key goals for Callisto's drug development programs.
Letter to Callisto Pharmaceuticals Shareholders
From Dr. Gary S. Jacob, CEO
April 11, 2006
Dear Fellow Shareholder:
I am pleased to share with you some of the note-worthy events and
progress that were made during the first quarter of 2006, including a
number of important milestones. The primary focus of management's
attention continues to be on moving our two current drugs in clinical
development, Atiprimod and L-Annamycin, forward in the clinic, and on
continuing to expand our pipeline of drug candidates to enter clinical
trials in the years to come.
Atiprimod and Carcinoid Cancer
The single most important advance made this first quarter was the
announcement of a completely new disease indication for Atiprimod,
Callisto's first-in-class anticancer drug. Atiprimod is presently in
two clinical trials, one in multiple myleoma and one in advanced
cancer patients. However, based on the observation of a clear response
in a carcinoid cancer patient, as well as additional encouraging data
in other patients, Callisto announced its plan to initiate a Phase
I/IIa clinical trial in advanced carcinoid patients, in addition to
the previously launched disease indications. Patients with advanced
metastatic carcinoid tumors have a very poor prognosis, and represent
an unmet medical need. Callisto plans to move aggressively forward
with evaluation of Atiprimod against this particular disease
indication, and hopes to have the first clinical trial underway in the
next few months. In addition, we plan to continue enrolling patients,
including those with carcinoid tumors and other liver-related cancers
in the ongoing Phase I/IIa trial in advanced cancer patients currently
underway at M. D. Anderson Cancer Center in Houston, Tx.
Clinical Progress with L-Annamycin
The first clinical trial with L-Annamycin, Callisto's drug to
treat acute leukemia, got under way in December, 2005 at the M. D.
Anderson Cancer Center under the direction of Dr. Hagop Kantarjian,
the senior principal investigator, and a leader in the development of
new therapies to treat leukemia patients. The trial is a single agent
evaluation of L-Annamycin in adult relapsed or refractory acute
lymphocytic leukemia (ALL) patients. During the first quarter of 2006,
two additional sites were added to this trial: 1) Montefiore Medical
Center in New York, NY, and 2) Roswell Park Cancer Institute in
Buffalo, NY. Callisto continues to move ahead with plans in 2006 to
initiate two addition clinical trials with L-Annamycin: 1) a single
agent Phase I/IIa trial in pediatric relapsed or refractory ALL
patients, and 2) a Phase I/IIa trial (in combination with Ara-C) in
adult relapsed or refractory acute myeloid leukemia patients.
Degrasyns - A New Class of Anti-cancer Agents
A key accomplishment in continuing to build our oncology franchise
was the successful in-licensing of a new class of cancer drugs called
Degrasyns, from the University of Texas M. D. Anderson Cancer Center,
for development as anti-cancer agents. The novel anti-cancer activity
of this class of drug candidates relates to its ability to selectively
degrade key proteins that are involved in tumor growth and survival.
The licensing of the Degrasyn class is a clear demonstration of
Callisto's commitment to developing a robust portfolio of anti-cancer
drugs.
Guanilib - A Revolutionary Drug Candidate
We also announced progress with the pre-clinical development of
Guanilib our first-in-class drug to treat ulcerative colitis.
Encouraging animal model data and mechanistic studies were announced
in March, 2006 and will be presented in an abstract on Guanilib at the
Digestive Disease Week conference to be held on May 20-25, 2006. We
continue to move forward with preclinical development of this
innovative therapy, with the stated intention of filing an
Investigational New Drug (IND) application in late 2006 or early 2007.
Guanilib is a truly novel and innovative drug candidate and we are
very excited to proceed in our development programs.
Callisto's recent focus on clinical development has led to the
continual buildup of our clinical research team in 2005. In March we
announced the appointment of Dr. Arthur Sytkowski as Clinical Trial
Advisor and Medical Safety Monitor, and the appointment of Dr. Moshe
Talpaz as Chairman of the Callisto Scientific Advisory Board.
Importantly, we improved our financial position by closing on
$5.14 million in equity financing in the first quarter of 2006,
providing additional funds for our clinical development efforts.
Finally, in January, 2006, First Berlin, an independent
German-based equity research house initiated coverage of Callisto
Pharmaceuticals, Inc.
2006 is a pivotal year for Callisto as we gain a better picture of
the clinical opportunities for our two drugs: L-Annamycin and
Atiprimod. I appreciate the support you have shown during these
building years and believe it will be rewarded as our programs reach
fruition.
Sincerely,
Gary S. Jacob, Ph.D.
Chief Executive Officer
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 other significant health care markets, including ulcerative colitis ulcerative colitis Inflammation of the colon, especially of its mucous membranes. The inflamed membranes develop patches of tiny ulcers, and the diarrhea contains blood and mucus. and biodefense. One of the Company's lead drug candidates, L-Annamycin, is being developed as a treatment for forms of relapsed acute leukemia acute leukemia Hematology A rapidly progressive malignancy of sudden onset, characterized by an uncontrolled 'clonal' proliferation of immature WBCs which replace BM and spill into the peripheral circulation; untreated AL may be fatal in wks to months. , a currently incurable incurable /in·cur·a·ble/ (in-kur´ah-b'l) 1. not susceptible of being cured. 2. a person with a disease which cannot be cured. in·cur·a·ble adj. blood cancer. Callisto initiated a clinical trial of L-Annamycin in adult relapsed acute lymphocytic leukemia acute lymphocytic leukemia n. See acute lymphoblastic leukemia. acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults patients in 4Q 2005. L-Annamycin, a new compound from the anthracycline anthracycline /an·thra·cy·cline/ (-si´klen) a class of antineoplastic antibiotics produced by Streptomyces peucetius and S. coeruleorubidus, including daunomycin and doxorubicin. family of proven anti-cancer drugs, has a novel therapeutic profile, including activity against resistant diseases and significantly reduced cardiotoxicity cardiotoxicity /car·dio·tox·ic·i·ty/ (kahr?de-o-tok-sis´i-te) the quality of being cardiotoxic. cardiotoxicity A deleterious effect on the heart. See Cocaine 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 multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility , a blood cancer, and advanced carcinoid carcinoid /car·ci·noid/ (kahr´si-noid) a yellow circumscribed tumor arising from enterochromaffin cells, usually in the gastrointestinal tract; the term is sometimes used to refer specifically to the gastrointestinal tumor cancer. Atiprimod is presently in Phase I/IIa human clinical trials in relapsed multiple myeloma patients, and advanced cancer patients, respectively. Callisto also has drugs in preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. development for gastro-intestinal inflammation inflammation, reaction of the body to injury or to infectious, allergic, or chemical irritation. The symptoms are redness, swelling, heat, and pain resulting from dilation of the blood vessels in the affected part with loss of plasma and leucocytes (white blood , and a program focused on the development of a drug to protect against Staphylococcus staphylococcus (stăf'ələkŏk`əs), any of the pathogenic bacteria, parasitic to humans, that belong to the genus Staphylococcus. The spherical bacterial cells (cocci) typically occur in irregular clusters [Gr. and Streptococcus streptococcus (strĕp'təkŏk`əs), any of a group of gram-positive bacteria, genus Streptococcus, some of which cause disease. 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 Frankfurt Stock Exchange The largest of Germany's eight securities exchanges, operated by Deutsche Borse AS. under the ticker symbol Ticker Symbol An arrangement of characters (usually letters) representing a particular security listed on an exchange or otherwise traded publicly. When a company issues securities to the public marketplace, it selects an available ticker symbol for its securities which investors CA4. For additional information, visit www.callistopharma.com. Forward-Looking Statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2005, 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion