Navigation Links
Callisto Pharmaceuticals Completes Enrollment of Phase II Trial of Atiprimod in Neuroendocrine Cancer
Date:9/20/2007

NEW YORK, Sept. 20 /PRNewswire-FirstCall/ -- Callisto Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new drug treatments in the fight against cancer and gastrointestinal disorders and diseases, announced today that complete enrollment of its Phase II clinical trial of Atiprimod to treat low to intermediate grade neuroendocrine carcinoma (advanced carcinoid cancer) was accomplished ahead of schedule. The trial, designed to enroll 40 patients, presently has patients enrolled at seven clinical sites in the U.S., and was closed to further enrollment with the addition of the 40th patient.

"This Atiprimod trial was initiated in November, 2006 and we are pleased with the tremendous pace of enrollment that we experienced," said Dr. Gary S. Jacob, Chief Executive Officer of Callisto. "We have patients who have now been on our drug for as long as 11 months, and we expect that by January of 2008 the bulk of patients will have been treated for 6 months or more on our drug. We anticipate at that time releasing interim data from the trial as well as planning for a meeting with FDA on the design of a registration trial."

The primary objective of the Phase II clinical trial was to evaluate efficacy of Atiprimod in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable cancer and who have progression of their disease despite standard therapy (octreotide). Patients, after signing an informed consent, were required to complete two weeks of a symptoms diary to establish their symptoms baseline before commencing Atiprimod dosing. Efficacy evaluations include the measure of target lesions (per RECIST), and the quantization of symptom relief. Further details of this trial can be found at http://www.clinicaltrials.gov.

About Atiprimod

Atiprimod is an orally bio-available small molecule drug that displays multiple mechanisms of action. The drug has been shown to be antiangiogenic, inhibit secretion of VEGF and IL-6, elicit an apoptotic response (programmed cellular death), and inhibit phosphorylation of key kinases involved in tumor progression and survival including Akt and STAT3. The drug is presently in two clinical trials: a Phase II trial in advanced carcinoid cancer patients, and a Phase I/IIa human clinical trial in relapsed or refractory multiple myeloma patients. Callisto earlier announced in June, 2006 interim data from a Phase I trial of Atiprimod in advanced cancer patients. The patients who were entered into this trial had growing tumors and symptoms that were no longer controlled by the standard therapies utilized. During treatment, three of the five advanced carcinoid patients had measurable tumor regressions and loss of many of the debilitating symptoms of this disease.

About Carcinoid Cancer

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. Approximately 7,000 cases of carcinoid cancer are diagnosed in the U.S. annually, with the number increasing over the past 20-30 years. 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. Carcinoid tumors typically produce a condition called "carcinoid syndrome" which is caused by the release of hormones by the tumors into the blood stream. The symptoms vary depending on which hormones are released by the tumors, but typically include diarrhea, facial flushing, wheezing, abdominal pain and valvular heart disease.

About Callisto Pharmaceuticals, Inc.

Callisto is a biopharmaceutical company focused on the development of new drugs to treat various forms of cancer and gastrointestinal diseases. 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 gastrointestinal disorders. One of the Company's lead drug candidates, Atiprimod is presently in a Phase II clinical trial in advanced carcinoid cancer patients, a neuroendocrine tumor, and in a Phase I/IIa human clinical trial in relapsed or refractory multiple myeloma patients. 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. L-Annamycin is currently in a Phase I clinical trial in adult relapsed or refractory acute lymphocytic leukemia, and in a Phase I clinical trial in children and young adults with refractory or relapsed acute lymphocytic leukemia or acute myelogenous leukemia. L- Annamycin, a member of the anthracycline family of proven anti-cancer drugs, has a novel therapeutic profile, including potential activity against multi- drug resistant tumors and significantly reduced cardiotoxicity, or damage to the heart, compared to currently available drug alternatives. Callisto also has a proprietary drug Guanilib in preclinical development for gastro- intestinal disorders. Callisto has exclusive worldwide licenses from Genzyme 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 http://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 for the year ended December 31, 2006, 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.

CONTACT: Gary Jacob of Callisto Pharmaceuticals, Inc., +1-212-297-0010


'/>"/>
SOURCE Callisto Pharmaceuticals, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Callisto Pharmaceuticals Announces Publication of Research Article on Atiprimod Preclinical Studies in Mantle Cell Lymphoma
2. Callisto Intends to Move Guanilib into Clinical Trials in Ulcerative Colitis
3. Inspiration Biopharmaceuticals Presents Data From Hemophilia Program at International Society On Thrombosis and Haemostasis (ISTH) Annual Meeting
4. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
5. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
6. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
7. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
8. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
9. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
10. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
11. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... 19, 2017 Shire plc (LSE: ... U.S. Food and Drug Administration (FDA) has acknowledged receipt ... Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine ... once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). The FDA is ... 20, 2017, the designated Prescription Drug User Fee Act ...
(Date:1/19/2017)... 19, 2017 Pfizer joins ... Milner Therapeutics Consortium   Major research ... Cambridge   The Milner Therapeutics ... ) as a partner to the Milner Therapeutics Consortium. ... the efficient transfer of materials between industry and academia ...
(Date:1/19/2017)... Florida , January 19, 2017 ... Trump administration appears serious about reducing the FDA,s ... and innovation in the medical drug industry, many ... ahead with new clinical trials and development of ... companies forging ahead with recent developments include:  Moleculin ...
Breaking Medicine Technology:
(Date:1/20/2017)... ... January 20, 2017 , ... A new partnership between ... they no longer use or need, from clothes to couches to dressers and bicycles. ... and take them to the nearest Goodwill donation center through February 28th. , ...
(Date:1/20/2017)... Miami, Florida (PRWEB) , ... January 20, 2017 , ... ... in head lice cases in families with school-aged children since the holiday season. ... spend the holidays with their families, sharing hugs and taking photos, which is the ...
(Date:1/20/2017)... ... January 20, 2017 , ... ... its sugar-free alternative VW+ 002. The drinks have been produced in collaboration with ... to perform during your workout. , After a successful launch in Sweden last ...
(Date:1/20/2017)... ... 2017 , ... D R Burton Healthcare Products LLC, makers ... in a study indicating superior performance against competitive products in secretion clearance. ... Positive Expiratory Pressure Devices During Simulated Breathing“ was published in the winter issue ...
(Date:1/20/2017)... ... January 20, 2017 , ... “God's Miracle Man: Against All Odds”: an ... of published author, Keith C. A. Tucker, son of Minister Delores Pinnock and a ... by Reverend Mark Hardy , “While sitting up in bed, I felt a pounding ...
Breaking Medicine News(10 mins):