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Alfacell begins new clinical trial in pancreatic cancer; Study to compare its ONCONASE + tamoxifen vs. GEMZAR.


BLOOMFIELD, N.J.--(BUSINESS WIRE)--Aug. 20, 1996--Alfacell Corp. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:ACEL) announced today that it has begun a new Phase III multi-center, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 trial comparing its novel cancer therapeutic ONCONASE(R) used in combination with tamoxifen to GEMZAR(R) in patients with advanced pancreatic cancer.

This trial will compare both survival and quality of life of these patients. According to the American Cancer Society American Cancer Society,
n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research,
, pancreatic cancer is the fifth most common cause of cancer deaths and is responsible for approximately 28,000 deaths annually. More importantly, the incidence has tripled in the past 40 years.

"Pancreatic cancer is one of the most difficult tumors to treat," stated Philomena McAndrew, M.D., Medical Oncologist, Cedars-Sinai Medical Center Cedars-Sinai Medical Center is a world-renowned hospital located in Los Angeles, California. History
Cedars-Sinai is the result of a merger in 1961 between two major Los Angeles hospitals, Cedars of Lebanon and Mount Sinai Home for the Incurables, with Steve Broidy as
, Los Angeles. "In the advanced stage, many patients die within 90 days of diagnosis -- thus underscoring the need for more treatment options that allow terminal patients to enjoy a better quality and quantity of life."

Alfacell believes that this protocol will provide important information on the comparative efficacy and safety of these two regimens since GEMZAR is the first drug in several decades approved by the Food and Drug Administration for patients with pancreatic cancer. Data from this study will be included in the company's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) and will be useful in the planning of its worldwide marketing strategy for ONCONASE. Alfacell's ongoing Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the , initiated in December 1995, will now include patients who have been previously treated with GEMZAR.

"This expansion of our pancreatic cancer clinical program will not only maximize the opportunity for patients to receive alternative therapies, but will also allow the oncology community to better assess therapeutic options for disease management in the future," stated Stanislaw Mikulski, M.D., Alfacell's medical director.

Developed by Alfacell scientists, ONCONASE is a novel RNase protein used in the investigational treatment of patients with solid tumors, most of which are resistant to other chemotherapeutic drugs. ONCONASE, the only cytotoxic RNase currently in clinical trials, has been used in the treatment of over 350 patients with a variety of solid tumors and has demonstrated in vitro and in vivo activity in multiple-drug resistance (MDR MDR,
n See multidrug resistance.

MDR,
n the abbreviation for minimum daily requirement, specifically the Minimum Daily Requirements for Specific Nutrients compiled by the United States Food and Drug Administration.
) tumor models. MDR is thought to be responsible for approximately 90% of chemotherapy failures. In addition to the company's clinical program for pancreatic cancer, Alfacell is also conducting a multi-center Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
phase II
 in patients with malignant mesothelioma.

Alfacell Corp., a biopharmaceutical company located in Bloomfield, is engaged primarily in the research and development of novel ribonuclease Ribonuclease

A group of enzymes, widely distributed in nature, which catalyze hydrolysis of the internucleotide phosphodiester bonds in ribonucleic acid (RNA).
 enzymes for various therapeutic applications. The company's common stock is traded in the over-the-counter market under the symbol "ACEL".

CONTACT: Alfacell Corp.

Donna Brasko, 201/748-8082
COPYRIGHT 1996 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1996, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Aug 20, 1996
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