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AVI BioPharma And ImmunoTherapy Corporation Select Pharmaceutical Research Associates to Initiate Phase II Clinical Trials of AVICINE In Prostate Cancer Patients.


PORTLAND, Ore.--(BW HealthWire)--July 15, 1998--AVI BIOPHARMA (AVI (Audio Video Interleaved) A Windows multimedia video format from Microsoft. It interleaves standard waveform audio and digital video frames (bitmaps) to provide reduced animation at 15 fps at 160x120x8 resolution. Audio is 11,025Hz, 8-bit samples. )(Nasdaq: AVII, AVIIW) and ImmunoTherapy Corporation (ITC ITC (Brit) n abbr (= Independent Television Commission) → Fernseh-Aufsichtsgremium

ITC n abbr (BRIT) (= Independent Television Commission) →
) today selected Pharmaceutical Research Associates (PRA PRA - PRAgmatics.

The language used by COPS for specification of code generators.

["Metalanguages of the Compiler Production System COPS", J. Borowiec, in GI Fachgesprach "Compiler-Compiler", ed W. Henhapl, Tech Hochs Darmstadt 1978, pp. 122-159].
), a leading contract research organization, to conduct a Phase II clinical study of the therapeutic cancer vaccine, AVICINE(tm), for the treatment of prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. . This trial will mark the first time this type of therapeutic vaccine has been used to study its effect on Prostate Specific Antigen PSA (Prostate specific antigen)
A tumor marker associated with prostate cancer.

Mentioned in: Tumor Markers
 (PSA (Professional Services Automation) An information system designed to organize, track and manage all opportunities, work, resources, costs, revenues and invoices to improve the productivity and efficiency of the workforce. ) levels.

A total of 24 prostate cancer patients will be evaluated in the Phase II trial, which will monitor quality of life benefits, tumor suppression and PSA levels in treated patients. PRA will conduct the multi-center study in the United States to conform with both U.S. and European regulatory approval requirements. AVICINE is being manufactured under GMPs for these clinical studies and patient enrollment is expected to begin in the next two to three months with a total study time of approximately one year.

Dr. Richard Angelo, Project Manager for PRA, stated, "PRA is committed to providing AVI and ITC with the expertise required to complete this important clinical evaluation. Our dedicated clinical team is uniquely qualified to provide high-quality service that advances AVICINE's development."

Denis Denis, king of Portugal: see Diniz.  R. Burger, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of AVI BioPharma and Jeffrey Lillard, Managing Officer of ITC, stated, "We look forward to working with PRA in conducting an additional late-stage study of our therapeutic cancer vaccine, AVICINE. By early 1999, we expect to have three late stage cancer studies in progress including a Phase III licensing trial in colorectal cancer, a Phase II/III trial in pancreatic cancer and a Phase II study in prostate cancer. We are excited about our strong cancer vaccine technology, which we believe is well complemented by our unique antisense antisense, DNA or RNA manipulated in a laboratory so that its components (nucleotides) form a complementary copy of normal, or "sense," messenger RNA (mRNA; see nucleic acid).  and drug delivery platforms. Together, these programs represent a dynamic development portfolio for the treatment of cancer and life-threatening diseases. We remain encouraged by the data we have observed in each of these areas to date and are actively seeking strategic partners who will share our vision and accelerate our development efforts."

To date, more than 125 cancer patients have been treated with AVICINE, which completed Phase II multi-center clinical studies for pancreatic cancer and metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.

Mentioned in: Coagulation Disorders


metastatic

pertaining to or of the nature of a metastasis.
 colorectal cancer in early 1998. These trials provided evidence of objective anti-tumor responses, stabilization of tumor growth and apparent survival and quality of life benefits in some patients.

AVI BioPharma, formerly known as AntiVirals Inc., is dedicated to the development and commercialization of products for the treatment of life-threatening diseases. In the antisense field, the company has developed a patented class of gene targeted drugs, called NEUGENES(R), which may be useful in the treatment of a wide range of human diseases including cancer and restenosis, a cardiovascular disease. The company has also developed a drug delivery technology, called CYTOPORTER(tm), which may be useful in improving delivery of many FDA-approved drugs, drugs in development, and antisense compounds. In February 1998, AVI BioPharma and ITC entered into an agreement whereby AVI will acquire ITC. The acquisition has been approved by the Board of Directors of both companies and is pending ITC and AVI shareholder approval.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, the results of research and development efforts, the results of pre-clinical and clinical testing, the effect of regulation by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 and other agencies, the impact of competitive products, product development, commercialization and technological difficulties, and other risks detailed in the Company's Securities and Exchange Commission filings.

   CONTACT: AVI BioPharma
             Denis R. Burger, Ph.D.
             President & CEO
             Alan P. Timmins
             COO & CFO
             503/227-0554
                  or
             Investor Relations Contact:
             CPR Financial Communications, LLC
             Olga M. Fleming
             Sue L. Yeoh
             201/641-1911


COPYRIGHT 1998 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Article
Geographic Code:1USA
Date:Jul 15, 1998
Words:640
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