Clinical Studies

Virginia Tech College of Osteopathic Medicine
An IND has been granted for this Phase II (safety and efficacy) study to examine the concurrent therapeutic benefit of the PdLA formulation in multiple myeloma patients (PAMS study).

Stony Brook Medical Center
Currently, an IND study is being conducted examining safety and adjunctive support of thePdLA formulation Poly MVA in glioblastoma patients (DESSTINI-A).

Cipla Cancer Palliative Care and Training Centre

A Palliative Care Study was conducted by the Indian pharmaceutical company Cipla Ltd. (Mumbai, India). Patients took the PdLA supplement Rejeneril-A for 24 days, followed by a 12 day clearance period. The following parameters demonstrated statistically significant patient improvement: Cognitive Functioning, Emotional Functioning, Social Functioning, Fatigue, Sleep Disturbances, and Appetite Loss.

CIRCLE MEDICAL LLC

Based on his pilot study demonstrating alleviation of HIV-associated fatigue and improved quality of life in AIDS patients, Dr. Blick applied for an IND for the project entitled REFRESH (Rejeneril for Fatigue Dose-Ranging Efficacy Study in HIV/AIDS). This IRB approved study was a prospective, multicenter, randomized, open-label, dose-ranging, comparative study. Since Stony Brook’s DESSTINI-A glioblastoma study was approved shortly after this approval, the decision was made to fund that program.

Stony Brook University
The Department of Neurology at Stony Brook University completed a dose-escalation safety study and kinetics profile (DESSTINI) of the Palladium Lipoic Acid formulation (Poly MVA) in preparation for a formal glioblastoma program. This was an IRB approved study, which was monitored by a DSMB (Data Safety and Monitoring Board), as well as, being granted an IND from the FDA.

Florida Hospital

In collaboration with Florida Hospital’s Cancer Institute, Dr. Mueller developed a post ovarian cancer treatment dose-escalation study for improved quality of life using the PdLA supplement, Poly MVA. An IND application was approved by the FDA (6/07), however, funding restrictions did not allow the study to progress.

Stony Brook University

A university Phase I (SAFETY) study entitled PUNCH (Poly MVA Utilized as Neuroprotection against Chronic Hypertension) of PdLA supplement was completed. 13 research subjects received a single dose of Poly MVA (10 mL/day) for varying time periods. The product was deemed safe and a subsequent IND was submitted to the FDA for Poly MVA use to treat the ischemic damage associated with chronic hypertension., however, funding restrictions did not allow the study to progress.

Century Wellness Clinic

Dr. Forsythe began collecting observational data in January of 2004, and has over 212 stage IV cancer patients in his observational cohort. His best responders are prostate, breast and lung cancer. The typical oral dosage used is 40 mL or 8 teaspoons per day.