LA BioMed granted $1.3M for investigating ESAI's KRONOS IV in correcting erectile dysfunction

Research to attempt to activate endogenous stem cells with company's drug, KRONOS IV

Las Vegas-based Endogenous Stem Cells Activators Inc. (ESAI) announced today that it will award a $1.3 million grant to Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LABioMed) for pre-clinical studies aimed at activating penile endogenous (adult) stem cells with the company's drug, KRONOS IV. ESAI's ultimate goal is the use of the drug to provide long-term correction of male erectile dysfunction in an aged population, as well as in patients with diabetes and those who have undergone prostatectomy for prostate cancer.

ESAI and LA BioMed signed a research contract in which Nestor Gonzalez-Cadavid, PhD, the principal investigator for the proposed research at LA BioMed, will lead the institute's research team. Dr. Gonzalez-Cadavid will be using technology he has applied successfully before that led to the restoration of erectile function and the generation of new cells in the penile tissues of animal models after the implantation of adult stem cells derived from skeletal muscles. The repair of penile tissue was a result of the generation of new smooth muscle cells that replaced the ones lost during the aging process.

"We appreciate ESAI's vote of confidence in LA BioMed and our research capabilities," said Dr. Gonzalez-Cadavid. "While the use of adult stem cells derived from skeletal muscles in our previous research is a novel and promising approach, its application in the clinic is still remote because it is invasive, restricted to the donor patient, expensive to generate and difficult to achieve approval under the Food and Drug Administration's (FDA) regulations. KRONOS IV is based upon a generic drug presently on the market and approved by the FDA in the treatment of a certain medical condition, making it more available and less expensive."

Alfred T. Sapse, MD(r), ESAI's president, said the ESAI technology has "transformed this generic drug by using proprietary techniques - including novel ways of manufacturing it - into a potentially effective activator of endogenous stem cells into certain desired cell lineages for tissue repair without changing the generic drug's formulation."

The research contract between ESAI and LA BioMed calls for basic and pre-clinical research on the drug over three years.

"ESAI assumes, based upon preliminary results, that a positive pre-clinical outcome for erectile dysfunction with the KRONOS IV compounds could be obtained in as few as 12 months," said Dr. Sapse. "If that occurs, ESAI then plans to proceed with clinical studies as carried out previously with other off-label drugs in three groups of ten patients each. If successful, this would enable physicians to prescribe KRONOS IV as an off-label drug in the treatment of erectile dysfunction."

Sapse said ESAI also intends to continue to collaborate with LABioMed within the current contract with pre-clinical testing and basic research to provide the answers on how KRONOS IV works locally on the regeneration of the smooth muscle, nerve terminals and various other types of cells in the penile corpora cavernosa, or erectile tissue. In addition, the research will seek to identify both the specific cellular targets for this action and any potential systemic effects throughout the body.