Good Morning My Friends,
Anvirzel was once thought of as an alternative therapy. So glad to see
that it is being utilized in FDA approved clinical trials. I have heard
that this therapy or medicine had been very successful and am glad to
see it recognized as one that is being considered for conventional
treatment as well. Hope and pray that it succeeds.
http://www.ozelle.com/
God Bless You All,
marty auslander
Title: Ozelle Pharmaceuticals, Inc's Home Page
Ozelle Pharmaceuticals, Inc.
11825 IH 10 West, Ste 213 San Antonio, TX 78230 (210)
690-0022 Phone (210) 690-3015 Fax
USFDA IND
#58,345
ANVIRZEL IS AN EXPERIMENTAL DRUG UNDER DEVELOPMENT
AND IS REQUIRED BY FDA REGULATIONS TO UNDERGO CLINICAL TRIALS TO BE APPROVED FOR
PRESCRIPTION USE. THIS PRODUCT IS NOT MANUFACTURED IN COMMERCIAL QUANTITIES AND
PRODUCTION IS LIMITED TO GUIDELINES AND DIRECTIVES SET FORTH BY THE U.S. FDA. NO
COMMENT OR ANNOUNCEMENT OTHER THAN THOSE GENERATED BY OZELLE PHARMACEUTICALS,
INC. SHOULD BE CONSIDERED VALID OR AUTHORIZED. COMMENTS MADE IN CHAT ROOMS ARE
NOT ENDORSED OR ENCOURAGED BY THE COMPANY. ONE SHOULD NOT RELY ON OR CONSIDER
THESE COMMENTS WHEN DETERMINING THEIR MEDICAL TREATMENTS. CERTAIN CHAT ROOMS AND
FORUMS CONTAIN MISREPRESENTATIONS AND
MISINFORMATION.
Proprietary Product:
AnvirzelTM ("Experimental Drug" in
development)
ANVIRZELTM IS AUTHORIZED BY THE FDA
FOR USE IN CLINICAL TRIALS (PHASE I).
Phase I Clinical Trials
are anticipated to commence on April 1st, 2000 at Cleveland Clinic, Cleveland,
Ohio.
Phase I Clinical Trials for this experimental drug will be limited
to 18 patients. Phase II Trials will be open to as many as 200 patients in each
of the following forms of cancer:
Melanoma
Advanced non-small cell Lung Cancer
Advanced Leiomyosarcoma
Advanced Hormone Refractory Prostate Cancer
Advanced Malignancies that have failed standard therapies
Compassionate Use for terminally ill patients afflicted by cancers not set
forth above will be considered and subject to FDA
approval
Phase II Trials are anticipated to be authorized for
commencement in July, 2000. To participate in these trials, patients selected
will be required to travel to their nearest regional site for periodic 2 day
examinations every 90 days. During the 90 day period, patients will self
administer the drug at home by intramuscular injection and will be required to
be examined by their personal physicians once a month or as
needed.
AnvirzelTM is a botanical drug
derived from the plant Nerium Oleander. Water-soluble extract from Nerium
Oleander was pioneered by Dr. Huseyin Ozel, a Turkish physician who began to
experiment with these extracts in the early 1970s.
Ozelle Pharmaceuticals, Inc., was founded in San Antonio,
Texas to further explore and develop the potential of this preparation which was
patented and trade-marked under the name AnvirzelTM.
In January 1997, Ozelle Pharmaceuticals supplied a quantity of a more refined
pharmaceutical version of Dr. Ozel's initial crude plant extract to Dr. Patrick
J. Kelly, a palliative care physician in Limerick, Ireland. Since that time, Dr.
Kelly has treated more than 100 terminally ill patients with various advanced
cancers as well as patients with AIDS. In September 1998, the USFDA authorized IND
#56,826 allowing the company to supply AnvirzelTM to
a small number of terminally ill metastatic cancer patients. Primarily, the
predominant number of these patients were leiomyosarcoma afflicted.
Immunology
studies continue under the direction of Dr. Wendell Winters, Ph.D. at the
University of Texas Health Science Center San Antonio.
Applications for
Phase I Trials are currently being accepted. Applications to enter Phase II
Trials will be accepted on or after June 1st, 2000. For application
information contact Mr. Joseph Nester at Ozelle Pharmaceuticals, Inc. (210)
690-0022 or by fax (210) 690-3015.
All rights reserved 1999-2000, Ozelle Pharmaceuticals, Inc. No
unauthorized use of contents with out expressed permission of Ozelle
Pharmaceuticals, Inc. To contact through email: Ozelle Pharmaceuticals,
Inc.
