Posted by jrbecker on May 27, 2003, at 11:25:29
Palonosetron is a 5HT3 antagonist in phase III trials. It's being developed to combat nausea experienced from chemotherapy. However, the drug might also be used to combat nausea and anxiety associated with some forms of depression and also treat SSRI-induced nausea.
http://biz.yahoo.com/bw/030527/275104_1.html
Press Release Source: MGI PHARMA, Inc.
MGI PHARMA & HELSINN Announce Upcoming Presentations of Phase III Clinical Data for Palonosetron at the 39th Annual Meeting of the American Society of Clinical Oncology -ASCO-
Tuesday May 27, 7:00 am ET
MINNEAPOLIS--(BUSINESS WIRE)--May 27, 2003--MGI PHARMA, Inc. (Nasdaq:MOGN - News), an oncology-focused company, and its partner HELSINN HEALTHCARE SA, a privately-owned Swiss pharmaceutical group, today announced that phase III data will be presented on the companies' lead product candidate, palonosetron at the 39th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago, IL from May 31 - June 3. Two oral and three poster presentations will provide insight into Phase III pivotal data for palonosetron, a potent, highly selective 5-HT3 receptor antagonist for the prevention of chemotherapy-induced nausea and vomiting (CINV). The palonosetron NDA is currently being reviewed by the FDA. Under the PDUFA (Prescription Drug User Fee Act), the FDA's goal is to review and act on the NDA within 10 months of its September 2002 submission. The marketing of palonosetron is subject to review and approval by the FDA.
Below is a list of palonosetron abstracts to be presented at the 2003
ASCO annual meeting:Title: Palonosetron (PALO) is more effective than ondansetron (OND) in
preventing chemotherapy-induced nausea and vomiting (CINV) in patients
receiving moderately emetogenic chemotherapy (MEC): Results of a phase
III trial
Integrated Education Session "Pathogenesis-Based Treatment of
Mucositis and Nausea and Vomiting", Abstract #2918; May 31 from 12:45
- 2:15 p.m.Title: Palonosetron (PALO) compared with ondansetron (OND) or
dolasetron (DOL) for prevention of acute and delayed
chemotherapy-induced nausea and vomiting (CINV): combined results of
two phase III trials
Oral Presentation "Patient Care", Abstract #2932; June 1 at 3:30 p.m.Title: Single IV dose of palonosetron (PALO), a potent 5-HT3 receptor
antagonist (RA), demonstrates sustained prevention of nausea and
vomiting for 5 days following moderately emetogenic chemotherapy (MEC)
General Poster Session, Brd. V2, Abstract #3055; May 31 from 2:00 -
5:30 p.m.Title: Palonosetron (PALO) is a safe and well-tolerated 5-HT3 receptor
antagonist (RA): Safety results of a phase III trial
General Poster Session, Brd. Q5, Abstract #3028; May 31 from 2:00 -
5:30 p.m.Title: Protection against chemotherapy-induced nausea and vomiting
(CINV) is maintained over multiple cycles of moderately (MEC) or
highly emetic chemotherapy (HEC) by palonosetron (PALO), a potent
5-HT3 receptor antagonist (RA)
General Poster Session, Brd. S6, Abstract #3041; May 31 from 2:00 -
5:30 p.m.About HELSINN HEALTHCARE
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland. HELSINN's core business is the licensing of pharmaceuticals in therapeutic niche areas. The company's business strategy is to in-license early-stage new chemical entities and complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe). HELSINN's products are eventually out-licensed to its marketing partners for distribution. The active pharmaceutical ingredients and the finished dosage forms are manufactured at HELSINN's cGMP facilities and supplied worldwide to its customers. For more information about HELSINN, please visit the company's Web site at www.helsinn.com.
About MGI PHARMA
MGI PHARMA, Inc. is an oncology-focused biopharmaceutical company that acquires, develops and commercializes proprietary products that address the unmet needs of cancer patients. MGI has a balanced product portfolio of proprietary pharmaceuticals, and intends to become a leader in oncology. MGI markets SalagenŽ Tablets (pilocarpine hydrochloride) and HexalenŽ (altretamine) capsules in the United States. The Company directly markets its products in the U.S. and collaborates with various alliances in international markets. For more information about MGI, please visit the company's Web site at www.mgipharma.com.
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