Jul 20 2012
The first patient has now been enrolled into the Phase 1 clinical trial
sponsored by Viral Genetics' (OTC Pink: VRAL) and supported by a
donation from Scott and White Foundation. The trial will study Metabolic
Disruption Technology (MDT) compounds in combination with an existing
cancer therapy to treat drug-resistant ovarian cancer. A total of up to
24 patients will receive combination treatment of hydroxychloroquine and
sorafenib (marketed as Nexavar™) under primary investigator, Tyler
Curiel, M.D., MPH, a medical oncologist affiliated with The Cancer
Therapy and Research Center (CTRC) of The University of Texas Health
Science Center at San Antonio. This clinical trial is the first
sponsored by Viral Genetics based on the licensed research of Dr. M.
Karen Newell-Rogers, the Company's Chief Scientist, and represents a
milestone in the transition of the Company from preclinical- to
clinical-stage. Patient enrollment is also expected to commence at Scott
and White Hospital as soon as internal review procedures there are
finalized.
"Patient enrollment marks the formal beginning of a clinical trial and
so we are quite happy to get underway after much preparation and hard
work by our team members, and Dr. Curiel's group," said Haig Keledjian,
President of Viral Genetics. "I want to emphasize that we would not have
proceeded with this choice of one MDT compound if we and our advisors
were not confident that it held real promise for patients, but one
should also appreciate the severity of the illnesses we are attempting
to treat in this study. We advise optimistic but cautious and restrained
expectations."
Because of the staggered nature of patient enrollment which calls for a
few patients to be enrolled and treated at low doses prior to enrolling
additional patients at higher doses, full enrollment of the study could
take up to a few months. Follow up and patient observation will continue
post-treatment for up to 12 months. The study can be stopped at any time
for safety reasons.