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CLINICAL TRIALS OPEN IN MANILA TO TEST THE WORLD'S FIRST TARGETED INJECTABLE
GENE DELIVERY SYSTEM FOR TREATING METASTATIC CANCER
LOS ANGELES, Calif., and Manila, Philippines - June 3, 2003 /Send2Press Newswire/ --
Epeius Biotechnologies Corporation (www.epeiusbiotech.com) today announced that
clinical trials have started in Manila, testing the world's first targeted
injectable gene delivery system for treating metastatic cancer, using Epeius'
Doctors infuse tumor-targeted "smart" nanoparticles engineered to transport
genetic medicine selectively to sabotage cancer cells and their blood supply
without causing serious side effects. This year, clinical trials for deadly
pancreatic cancer opened in Makati Medical Center to evaluate the safety and
efficacy of bioengineered nanoparticles guided by Epeius Biotechnologies
Targeted Delivery System (TDS) to seek out and deliver a designer "killer" gene
to cancerous tumors.
The clinical study, led by Drs. Gerardo H. Cornelio and Conrado Lorenzo III of
the Philippines combines state-of-the-art genetic medicine with a radically new
delivery system that re-defines the cutting edge of cancer therapy. The first
patients receiving intravenous infusions of the TDS-encapsulated genetic
"bullets" responded favorably without serious side effects. This represents a
momentous landmark in Philippine history: for Philippine physicians and U.S.
scientists to team up as pioneers and world leaders in the advancement of
Valentine's Day, 2003 marked the beginning of the gene therapy clinical trial
for metastatic cancer in Manila. Three patients with advanced pancreatic cancer
received infusions of the world's first targeted injectable gene therapy vector
in history. The saga began with a plea for compassionate usage from a man whose
wife was suffering from terminal pancreatic cancer. He had heard about a gene
therapy clinical trial opening in Los Angeles, California, and hoped that his
wife might be able to participate. Responding to the urgency of this request,
Dr. Gordon, Medical Director, and Dr. Frederick L. Hall, President and CEO of
Epeius Biotechnologies Corporation, arranged to export the Rexin-G targeted
vector and to open a compassionate use clinical trial in Makati Medical Center,
a prestigious tertiary care hospital in Manila.
With regulatory guidance and authorization from the Philippine Bureau of Food
and Drugs, a Dose-Escalation Regimen was given to each of the first two patients
(to ensure Safety), followed by an Intensification Regimen (to evaluate
Efficacy). In contrast to standard single-dose protocols, this innovative
Dose-Escalation Regimen cautiously evaluated safety while enabling effective
dosing over time. In the first patient, the combined regimens induced a
significant reduction in the size of metastatic tumor nodules and shrinkage of
the primary tumor without adverse side effects, thus improving and extending the
patient's life beyond the predicted survival time. In the second patient, the
reduction of the central tumor mass, and its retraction from major vessels, was
so profound as to enable the consideration of a "curative" surgical excision of
the cancerous pancreatic head, which was previously deemed inoperable.
Based on the remarkable single agent efficacy of Rexin-G observed in the first
two patients, a third patient was allowed to receive the initial Dose-Escalation
regimen front line - prior to the standard chemotherapy - to assail and
sensitize the tumors to subsequent chemotherapy. Follow-up CT scans showed a
significant decrease in the size of the primary pancreatic tumor, complete
eradication of more than a dozen metastatic liver nodules, and a decrease in the
size of the remaining liver nodules. While the investigators remain
appropriately cautious, the results are extremely promising.
The astonishing human story of compassion, perseverance, and rigorous medical
research that led to the groundbreaking clinical trial in Manila is chronicled
in an upcoming documentary entitled "The Holy Grail," produced by an
award-winning film director. The film depicts the mission and research
collaboration established between Dr. Erlinda M. Gordon, a physician/scientist,
and Dr. Frederick L. Hall, a biochemist/biophysicist, who together, against all
odds, undertook enormous scientific and medical challenges to produce what Dr.
Hall unassumingly refers to as "the accomplishment of a generation of
physician/scientists, for the benefit of cancer patients that conventional
medicine has failed".
The "cancer killing" designer gene within the targeted vector, designated
Rexin-G, is a genetically altered (mutant) form of the human Cyclin-G1 gene, a
growth-associated cell cycle control element that was first isolated by Dr. Hall
and his co-workers in 1994. Cyclin-G1 is a prospective oncogene that favors the
development of many types of cancer, including pancreatic, colon, breast and
prostate cancer, as well as bone and soft tissue tumors. To sabotage their cell
cycle and destroy the cancer cells, Dr. Hall engineered a mutant form of
Cyclin-G1 that, when translated into protein, blocks the essential function of
this growth control element. Further studies revealed that tumor-associated
angiogenesis, i.e., the new blood supply that feeds the growing tumors, is also
vulnerable to Cyclin-G1 knockout.
A built-in safety feature of Rexin-G is that it only affects rapidly dividing
cells, that is, cancer cells and their attendant blood supply, thus selectively
killing only the tumor cells while sparing the normal cells and tissues of the
body. Therefore, it is not expected to cause untoward systemic toxicity such as
hair loss, nausea and vomiting, bone marrow suppression, liver, kidney or any
organ damage. This aspect of Rexin-G enhances the quality of life of cancer
patients, in addition to its obvious desirable effects of arresting, reducing,
and/or eliminating the cancer.
The mission of Epeius Biotechnologies is to develop and commercialize the first
truly effective targeted delivery system (TDS) that can be injected directly
into a vein to deliver genes and/or molecular therapeutics preferentially to
cancerous tumors that have spread throughout the body (metastatic cancer),
without eliciting systemic side effects or organ damage. These features make
the targeted vectors more effective and less toxic than conventional medicines.
The lead product, Rexin-G, is the first tumor-targeted injectable gene therapy
vector that has been approved by both the U.S. FDA and the Philippine BFAD for
use in Phase I/II cancer clinical trials.
Source of news:
Epeius Biotechnologies Corporation
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