Navigation Links
Supratek Pharma Inc. announced today that under the Special Protocol
Date:11/28/2007

Assessment (SPA) process, it has obtained agreement with the United States Food and Drug Administration (FDA) for the design of its pivotal study protocol for SP1049C for the treatment of metastatic adenocarcinoma of the

upper gastrointestinal tract

MONTREAL, Nov. 28 /PRNewswire/ - The randomized, multicenter Phase III pivotal clinical trial will compare SP1049C plus Best Supportive Care (BSC) versus BSC alone for the treatment of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction and stomach who have failed adjuvant or 1st or 2nd line chemotherapy. Supratek Pharma is the sponsor of the international trial and its Clinical Oncology team will direct the clinical development program.

Oleg Romar, President and Chief Executive Officer, said, "We are pleased that the FDA has accepted our Phase III clinical protocol for SP1049C. This acceptance is a significant milestone and represents a critical step in the advancement of our clinical program. We believe that SP1049C, a novel anthracycline, may be a breakthrough treatment for this patient population. FDA's agreement in writing to a protocol reviewed under this process is considered binding on the review division of the FDA, providing that the protocol is followed and no substantial scientific issues arise regarding the safety or efficacy of the drug after the testing has begun."

"In the SPA communication, the FDA advised that the clinical design and analysis plan of our submitted protocol are suitable to provide evidence of safety and efficacy to support a new drug application (NDA) for SP1049C for the treatment of cancer of the upper gastrointestinal tract," said Dr. Christopher E. Newman, Vice President and Chief Medical Officer of Supratek Pharma. "The protocol for this trial was optimized with contributions from world opinion leaders in oncology. We look forward to the launching of this important pivotal study."

About SP1049C

-------------

Supratek's proprietary lead anticancer drug candidate, SP1049C, is the most advanced nanomedicine drug candidate that is based on polymer technology. This drug is a Biotransport(TM) composition of poloxamers with one of the most potent cytotoxic drugs, doxorubicin. SP1049C has been shown, in pre-clinical and clinical development, to have much higher efficacy and a novel mechanism of action against chemoresistant tumors in which the original drug is inactive. SP1049C has also obtained an Orphan Drug designation from the FDA for the treatment of esophageal carcinoma.

About Supratek Pharma Inc.

--------------------------

Supratek Pharma is an emerging pharmaceutical company focused on the treatment of drug resistant and metastatic cancers. The company has seven clinical-stage proprietary products in its pipeline. The next product in line for clinical development is SP-MET-X1. It is based on the Company's potential breakthrough discovery of a biochemical pathway and target consistently involved in metastasis formation and cancer progression. SP-MET-X1, the first drug developed in this new therapeutic class, is a novel use of an existing non-cancer drug that is specific to the new validated target.


'/>"/>
SOURCE Supratek Pharma Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Supratek Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract
2. Anemia and tropical diseases; Is pharmacogenomics ready for the clinic?
3. Mylan Commences Tender Offers and Consent Solicitations for Its 5.750% Senior Notes Due 2010 and 6.375% Senior Notes Due 2015 in Connection With Its Proposed Acquisition of Mercks Generic Pharmaceutical Business
4. Arena Pharmaceuticals to Present at the NewsMakers in the Biotech Industry Conference
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
6. The Pharma & Life Sciences Best Practice Database: an Industry Resource for Successful Techniques and Performance Benchmarks for Reaching the Top
7. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
9. National Pharmaceutical Council Announces New Strategic Focus, Search for New Leadership
10. AKELA Pharma Inc. announces positive results for the extension part of its Phase IIb Fentanyl TAIFUN(R) trial
11. Simcere Pharmaceutical Group Acquires a 51% Stake in Boda Pharmaceutical Co., Ltd.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/31/2016)... ... ... A book about the self-discovery of one’s limitless creative power, “ Unleash Your ... give readers the courage they need to embrace their creativity and unleash it as ... my life to learn and create what I set my heart with no limits ...
(Date:5/31/2016)... (PRWEB) , ... May 31, 2016 , ... "ProDrop 3D ... projects to the next level," said Christina Austin - CEO of Pixel Film Studios. ... Studios. With ProDrop 3D Abstract have the ability to generate and manipulate three-dimensional shapes ...
(Date:5/31/2016)... ... ... According to recent statistics, there are nearly half a million physical therapists ... physical therapy professional and every clinic has a duty to perform at the highest ... competitive industry is also essential. The solution that many physical therapy leaders turn to ...
(Date:5/31/2016)... (PRWEB) , ... June 01, 2016 , ... ... “ Psoriasis and smoking: links and risks ”. , As corresponding author Professor ... on the relation between smoking habits and psoriasis. Smoking influences the onset and ...
(Date:5/31/2016)... ... May 31, 2016 , ... ... that considers individuals’ genetic characteristics and the physical and behavioral worlds in ... in sync. In personalized medicine, diagnosing an individual’s disease depends on accurately ...
Breaking Medicine News(10 mins):
(Date:5/31/2016)... May 31, 2016 Aloe vera ... food, cosmetics and pharmaceuticals, with global volume to surpass ... 1.6 Bn. Demand for aloe vera extracts ... yogurts will continue its upward momentum in 2016 as ... boost positive sentiment on aloe vera, with wide-ranging applications ...
(Date:5/31/2016)... , May 31, 2016 The global ... coupled with surging prevalence of deaths from chronic diseases. According ... By Region, By Country): Opportunities and Forecasts (2016-2021) - (By ... Orthopaedic, Cardiovascular, Plastic Surgery, Wound Care); By Region-North America, ... UK, Germany , Italy ...
(Date:5/31/2016)... May 31, 2016 , Isansys  Lifecare, ... its Patient Status Engine wireless patient monitoring platform, as it ... Germany , Scotland and ... 2 nd generation system, launched earlier this year, is now ... , , This new technology significantly enhances ...
Breaking Medicine Technology: