Ostomyland's Wicked Wiki: Articles about new cancer drugs, treatment methods etc.

Most recent edit on 2007-02-01 14:46:53 by KathyFromEngland

Additions:
Callisto Pharmaceuticals, Inc. (Amex: KAL), a biopharmaceutical company primarily focused on the development of drugs to treat cancer, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to the company's drug candidate Atiprimod for the treatment of carcinoid tumors. Atiprimod, a small molecule antiangiogenic drug, is being developed by Callisto to treat advanced carcinoid tumors as well as relapsed multiple myeloma patients. Callisto plans to begin a Phase II clinical trial in advanced carcinoid cancer patients in the coming months.

Deletions:
Callisto Pharmaceuticals, Inc. (Amex: KAL), a biopharmaceutical company primarily focused on the development of drugs to treat cancer, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to the company's drug candidate Atiprimod for the treatment of carcinoid tumors. Atiprimod, a small molecule antiangiogenic drug, is being developed by Callisto to treat advanced carcinoid tumors as well as relapsed multiple myeloma patients. Callisto plans to begin a Phase II clinical trial in advanced carcinoid cancer patients in the coming months.

Edited on 2007-02-01 14:41:33 by KathyFromEngland

Additions:
~*Callisto Pharmaceuticals Granted Orphan Drug Designation For Atiprimod To Treat Carcinoid Tumors

*Callisto Pharmaceuticals Opens Second Site For Phase II Clinical Trial Of Atiprimod In Advanced Carcinoid Cancer Patients

Callisto Pharmaceuticals Opens Second Site For Phase II Clinical Trial Of Atiprimod In Advanced Carcinoid Cancer Patients
01 Feb 2007
Callisto Pharmaceuticals, Inc. (Amex: KAL; News; FWB: CA4), a developer of new drug treatments in the fight against cancer and other major health threats, announced today the opening of a second clinical site, the Dana-Farber Cancer Institute in Boston, MA, for its Phase II clinical trial of Atiprimod to treat low to intermediate grade neuroendocrine carcinoma (advanced carcinoid cancer). The Principal Investigator at the Dana-Farber Cancer Institute is Dr. Matthew H. Kulke. Subjects will also be seen at the following facilities: Brigham and Women's Hospital, Massachusetts General Hospital and Beth Israel Deaconess Medical Center. Other major cancer centers are currently reviewing the trial protocol, and the Company anticipates that additional sites will open in the near future.
"We are very excited to have this second site opened on the Phase II trial of Atiprimod in advanced carcinoid patients," said Dr. Gary S. Jacob, Chief Executive Officer of Callisto. "The addition of this well respected Boston cancer center will enable enrollment of patients from the New England area who are suffering from this terrible late-stage cancer, and will substantially enhance the pace of enrollment in this clinical trial of Atiprimod."
The primary objective of the Phase II clinical trial is 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, are required to complete two weeks of a symptoms diary to establish their symptoms baseline before commencing Atiprimod dosing. A maximum of 40 evaluable patients will be enrolled in this trial. Efficacy evaluations will 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∞.
Callisto announced the initiation of the Phase II trial of Atiprimod in advanced cancer patients on November 7, 2006. The first study site was the Hematology Oncology Services of Arkansas in Little Rock Arkansas.
http://www.medilexicon.com/medicalnews.php?newsid=62030∞

Deletions:
~*Callisto Pharmaceuticals Granted Orphan Drug Designation For Atiprimod To Treat Carcinoid Tumors

Edited on 2006-09-28 01:35:57 by KathyFromEngland

Additions:
About Carcinoid Tumours (carcinoids)

Deletions:

Edited on 2006-09-28 01:33:51 by KathyFromEngland

Additions:

Callisto Pharmaceuticals Granted Orphan Drug Designation For Atiprimod To Treat Carcinoid Tumors

Deletions:

Callisto Pharmaceuticals Granted Orphan Drug Designation For Atiprimod To Treat Carcinoid Tumors

Oldest known version of this page was edited on 2006-09-28 01:33:24 by KathyFromEngland []

Page view:

Articles about new cancer drugs, treatment methods etc.

Contents

*Callisto Pharmaceuticals Granted Orphan Drug Designation For Atiprimod To Treat Carcinoid Tumors

Callisto Pharmaceuticals Granted Orphan Drug Designation For Atiprimod To Treat Carcinoid Tumors

27 Sep 2006

Callisto Pharmaceuticals, Inc. (Amex: KAL), a biopharmaceutical company primarily focused on the development of drugs to treat cancer, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan drug designation to the company's drug candidate Atiprimod for the treatment of carcinoid tumors. Atiprimod, a small molecule antiangiogenic drug, is being developed by Callisto to treat advanced carcinoid tumors as well as relapsed multiple myeloma patients. Callisto plans to begin a Phase II clinical trial in advanced carcinoid cancer patients in the coming months.

"This marks an important step for Callisto's Atiprimod program," commented Callisto Chief Executive Officer Dr. Gary S. Jacob. "Callisto is planning an ambitious program of clinical development of Atiprimod in the carcinoid indication and the designation of orphan drug status gives additional assurance that we are well protected against any potential competition."

About Orphan Drug Designation

The Orphan Drug Act is intended to encourage development of products for rare diseases affecting fewer than 200,000 people in the United States. Orphan drug designation, along with approval by the FDA for commercialization of Atiprimod, entitles Callisto to seven years of market exclusivity in the United States, provided Callisto continues to meet certain conditions established by the FDA. During the seven-year exclusivity period, the FDA will not accept or approve other applications to market the same medicinal product for the same therapeutic indication.

For products designated as orphan drugs, the FDA not only provides market protection for the developing company, but also provides certain tax credits, eligibility for research grants and protocol assistance, opportunities for regulatory agency assistance on review of clinical protocols, and waiver of the Prescription Drug User Fee Act (PDUFA) filing fee.

About Atiprimod

Atiprimod is in clinical trials for advanced carcinoid tumors and relapsed multiple myeloma (MM). A small-molecule, orally available drug with antiproliferative and antiangiogenic activity, Atiprimod began an open-label Phase I/IIa clinical trial in relapsed MM patients in May 2004, and the trial has been extended to higher dosages of drug. Notably, Atiprimod was found to give encouraging activity in a cohort of carcinoid cancer patients in a Phase I clinical trial in advanced cancer patients. In June 2006 interim results from the trial were released showing that 3 of the 5 patients on the drug gave measurable tumour regressions and loss of debilitating symptoms. Callisto recently announced plans to open a Phase II clinical trial of Atiprimod in advanced carcinoid patients in 3Q 2006.
http://www.medilexicon.com/medicalnews.php?newsid=52772∞

Categories
CategoryCancer

Ostomyland's Wicked Wiki : CarcinoidTumourResearch

Articles about new cancer drugs, treatment methods etc.

Categories