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Topic Name: Researchers complete first clinical trial of Apatone for cancer treatment
Category: Biomedical
Research persons: Dr. Henryk Taper, Dr. Jack Summers , Dr. Jacques Gilloteaux, Dr. Ananias Diokno
Location: 5655 Hudson Drive, Suite 200, Hudson, OH, United States
Details
In a significant advancement in the
ongoing battle against
cancer, a group of researchers from
Summa Health System, IC-MedTech and other institutions have completed the
first ever FDA-approved
human clinical trial of Apatone®. Demonstrating promising results, Apatone
exploits a new strategy to selectively lower the level of compounds within tumor
cells that assist in energy production and protect against chemotherapy. This
non-toxic approach weakens and kills cancers in a novel way.
Apatone was discovered by Dr. Henryk Taper from
the
Catholic University of Leuven in Brussels, Belgium and was developed by Dr.
James Jamison and Dr. Jack Summers, both of
Summa Health System, and Dr. Jacques
Gilloteaux, now with the American University of
the Caribbean in St. Maarten. Their groundbreaking discovery found that
moderate doses of Apatone eliminate many types of cancer cells, including
prostate, bladder, renal and ovarian.
“This strategy targets cancer cells by their
inflammatory response,” explains Dr. Jamison. “It’s a different approach than
most other anti-tumor drugs, which target dividing cells or the development of
blood vessels within the tumor. Since normal cells use sugars or fats for energy
and cancer cells rely on glucose, the real key here is that Apatone resembles
glucose. As Apatone preferentially accumulates in cancer cells, it also supplies
quinone that weakens and can destroy the cancer cell from within.
“The bottom line is: Apatone selectively targets
and kills tumor cells using non-toxic biochemistry that protects surrounding
healthy tissue.”
Licensed in 2004 to IC-MedTech, Inc., a
California-based biotechnology company, the first clinical trial began in 2005
to evaluate the drug in prostate cancer patients. The clinical studies, which
were conducted at Summa Health System in
Akron, Ohio and with Dr. Ananias Diokno at
William Beaumont Hospital in Royal
Oak, Mich., examined the safety and effectiveness in 17 end-stage prostate
cancer patients for 12 weeks. These patients took Apatone orally each day. The
trials were supported by the
Beaumont Foundation, Summa Health System and IC-MedTech.
Throughout the trial, investigators monitored
prostate-specific antigen (PSA) levels, PSA velocity and PSA doubling times.
Although PSA is a protein normally produced by the prostate gland, individuals
with prostate cancer have increased levels. PSA velocity is the change of PSA
levels over time and PSA doubling time is the time it takes for a patient’s PSA
level to double.
“The results of the trial are very promising,”
said Dr. Jamison. “Sixteen of the 17 patients responded positively to the
Apatone and 13 showed a decrease in PSA velocity and an increase in PSA doubling
time. At the end of the treatment period, 15 patients opted to continue
treatment.”
Showing delays in the biochemical progression in
end-stage prostate cancer patients, the trial successfully demonstrated the
safety and efficacy of orally administered Apatone. Research is continuing and
insights into how this drug works have lead to collaborations and discoveries in
the field of liquid crystal compounds. Apatone is a Liquid Crystal
PharmaceuticalTM and has resulted in research sponsored at Summa and with Dr.
Chun-che Tsai at Kent State University. This work shows great promise for cancer
and other diseases.
“Ultimately, Apatone is intended to be
administered intravenously prior to chemotherapy so it can break down the
substances in a tumor that protect it from the chemotherapy and allow a greater
cell kill,” continued Dr. Jamison. “Between cycles and following completion of
chemotherapy, Apatone will be taken orally to help prevent or slow tumor
regrowth.”
Although the researchers are still working to
receive FDA approval for chemotherapy in conjunction with Apatone, the FDA
granted orphan drug status to IC-MedTech this year for the use of Apatone as
treatment for metastatic, or locally advanced, stage III and IV bladder cancer.
An orphan drug designation grants special status to a product to treat a rare
disease or condition.
Additional clinical trials are planned for
intravenous administration of Apatone in patients who have failed chemotherapy.
About Summa Health System
Summa Health System is one of the largest
organized delivery systems in Ohio. Encompassing a network of hospitals,
community health centers, a health plan, a physician-hospital organization,
research and a foundation, Summa is nationally renowned for excellence in
patient care and for exceptional approaches to health care delivery. Summa's
clinical services are consistently recognized by U.S. News and World Report and
Solucient. For more information, visit
www.summahealth.org.
Note for Biochemical engineering:
Biochemical engineering is a branch of chemical engineering that mainly deals
with the design and construction of unit processes that involve biological
organisms or molecules. Biochemical engineering is often taught as a
supplementary option to chemical engineering due to the similarities in both the
background subject curriculum and problem-solving techniques used by both
professions. Its applications are used in the pharmaceutical, biotechnology, and
water treatment industries.
About Researchers:
Dr. Henryk Taper
Catholic University of Leuven in Brussels
Dr. Jack Summers , Dr. Jacques Gilloteaux
American University of the Caribbean in St. Maarten
Dr. Ananias Diokno
William Beaumont Hospital in Royal Oak
Related Important Links:
http://www.biochemistry.org/
http://en.wikipedia.org/wiki/Biochemistry
http://www.phoenix5.org/glossary/PSA_doubling_time.html
http://www.springerlink.com/link.asp?id=101588
http://www.biochemj.org/bj/toc.htm
http://www.pcngcincinnati.org/psa/index.htm
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