<O.T.> Filipina presents cancer cure at international health summit

[Guest guest]

elr: got this from another health-related list. hope you don't mind the

off-topic post =) .

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> MANILA BULLETIN

> 09/16/2003

> RP doctor reports cancer breakthrough at US confab

> By Prudencio R. Europa

>

>

> BOSTON, Mass. - A Philippineborn physician-scientist, Dr.

> Erlinda M. de Guzman Gordon, told the three-day SRI World Summit

> Conference here of a significant breakthrough in the fight against

> cancer with the successful clinical trials of a " miracle drug "

>called

> Rexinaby by University of the Philippines physicians at the Makati

> Medical Center sponsored by her company, Los Angeles-based Epeius

> Biotechnologies.

>

>

>

> Holding the conference spellbound for 25 minutes as she made

> her presentation at the Radisson Hotel, the University of Santo

>Tomas-

> educated physician reported the encouraging results of the first

> human experience in the Philippines using Rexin-G as intravenous

> infusions for advanced pancreatic cancer.

>

>

> The gist of her presentation at the SRI World Summit:

>

>

> Rexin-G is a pathology-targeted (pathotropic) injectable

> retroviral vector bearing a cytocidal deminant negative cyclin G1

> construct that is authorized (and approved last week) by the US

> Federal Drug Administration in a Phase I clinical trial for

> metastatic colon cancer and by the Philippine Bureau of Food and

> Drugs for Stage IV pancreatic cancer. Three patients with Stage IV

> pancreatic cancer participated in the Makati Medical Center trial.

>

>

> The tumor response rate was 100 percent based on MRI or CT

> scan results. Further, Rexin-G infusions were not associated with

> nausea or vomiting, hair loss, hermodynamic instability, bone

>marrow

> suppression, liver or kidney damage over a threemonth observation

> period (early this year, starting Feb. 14).

>

>

> Taken together, the results of these studies provide

> encouraging evidence of the safety and efficacy of intravenous

>Rexin-G

> for Stage IV pancreatic cancer.?E

>

>

> In Los Angeles, Epeius Biotechnologies of which Dr. Gordon

>is

> founder and the medical director, announced the FDA approval of

>Rexin-

> G to combat pancreatic cancer.

>

>

> Epeius said the new drug is the product of research

> collaboration established between Dr. Gordon and Dr. Frederick L.

> Hall, American biochemist/physician, who together undertook

>enormous

> scientific and medical challenges to produce what Dr. Hall

> unassumingly refers to as " an accomplishment of a generation of

> phyisician/scientists, for the benefit of cancer patients that

> conventional medicine has failed. " ?E

>

>

> The FDA approval was based on the objective demonstrations

>of

> medical plausibility of Rexin-G, conducted by University of the

> Philippines physicians Dr. Gerardo H. Cornelio and Dr. Conrado

> Lorenzo III.

>

>

> For Epeius Biotechnologies, the major benefit to the company

> is market exclusivity for the Rexin-G product for all types of

> pancreatic cancer. The company said: " This represents a highly

> significant milestone for Epeius Biotechnologies since its lead

> product, Rexin-G, is the first gene therapy product to gain FDA

>orphan

> drug designation for pancreatic cancer. " ?E

>

>

> Tracing the involvement of Epeius in the Makati Medical

> Center clinical trials, Dr. Gordon said that she had received a

>plea

> for compassionate usage from a man (in Manila) whose wife was

> suffering from terminal pancreatic cancer. He had heard about a

>gene

> therapy clinical trial opening in Los Angeles, and hoped that his

> wife might be able to participate.?E

>

>

> Responding to the humanitarian appeal and the urgency of the

> request, Dr. Gordon and Dr. Hall arranged to export the Rexin-G

> targeted vector to open a " compassionate use clinical trial " in

> Makati Medical Center, a prestigious tertiary case hospital in

>Metro

> 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 for efficacy), " Dr.

> Gordon said.

>

>

> In the first patient, the combined regimens induced a

> significant reduction in the size of the 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, " she added.

>

>

> 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 curative surgical excision of the

> cancerous pancreatic head, which was previously deemed inoperable, "

> Dr. Gordon disclosed.

>

>

> Dr. Gordon said that while the Philippine doctors " remain

> appropriately cautious, she and her fellow scientists and

> biochemists said the results are extremely promising.

>

>

> The three-day Boston summit started Monday and ends

> Wednesday.

>

>

> Altogether, there were 65 speakers from 60 different global

> companies. The keynote address, bearing on " Prospects for

> Oligonucleotide-Based Drugs in Development " such as Regin-G, was

> delivered by Dr. Bob Brown, Ph.D., vice president for research and

> technology of Genta Inc. Dr. Gordon described Epeius as " an

>emerging

> biotechnological company " which she founded in Los Angeles.

>

>

>

> Copyright © 2003 Manila Bulletin. .

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