Viral Genetics' P-IND Clears FDA To Commence Clinical Trials in Humans - MarketWatch
Viral Genetics' P-IND Clears FDA To Commence Clinical Trials in Humans
Set to Begin First Ovarian Cancer Study Test Site for Metabolic Disruption Technology (MDT) Combination Therapy
SAN MARINO, Calif., May 21, 2012 (BUSINESS WIRE) --
A physician-initiated Investigational New Drug (P-IND) application
submitted to the FDA in late April, 2012, has cleared the FDA's
screening process with the requirement for a regular IND application
being waived, resulting in the company being able to begin the first of
at least two proposed clinical trial sites to investigate a potential
oncology treatment developed from Viral Genetics' (pinksheets:VRAL)
Metabolic Disruption Technology (MDT), which is licensed exclusively to
the Company. The P-IND -- part of a larger, coordinated research effort --
was submitted by the first test site at the Cancer Therapy & Research
Center (CTRC) at The University of Texas Health Science Center at San
Antonio, which includes patient enrollment at Scott and White Hospital
(S&W) in Temple, Texas. Additional test sites may also be added in the
future.
Enrollment and treatment of patients is expected to commence upon
completion of internal hospital Institutional Review Boards (IRBs),
which are already underway. The UT Health Science Center portion of the
study will commence when all approvals are finalized.
This clinical trial -- a milestone in the Company's transition from
preclinical to clinical-stage -- will be the first for the intellectual
property developed by Dr. M. Karen Newell Rogers, Viral Genetics' Chief
Scientist and licensed exclusively by the Company. It will examine the
safety and efficacy of one of Viral Genetics licensed MDT compounds in
combination with an existing cancer drug, sorafenib (marketed as
Nexavar(TM)) in the treatment of patients resistant or otherwise unsuitable
for standard treatments for stage III or IV ovarian cancer and related
carcinomas.
The Primary Investigator on the trial is Tyler Curiel, M.D., MPH, a
medical oncologist affiliated with the CTRC at the UT Health Science
Center. Dr. Curiel is leading this study as he investigates the efficacy
of combining two compounds in a cancer treatment that is hoped to cause
the starvation of tumor cells and enhanced anti-tumor immunity, leading
to the reduction of tumor size and reduced disease progression.....
