University of Missouri Medical Center
An ALS Palliative Care study is under development to attenuate fatigue and improve QOL using Poly MVA.
Virginia Tech College of Osteopathic Medicine
An IND was granted for a 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
An IND study was conducted examining safety and adjunctive support of the PdLA 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.
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’s Poly-MVA Clinical Results
The first part of the Clinical Oncology Outcome-Based investigation was over a 26-month period and was conducted on 212 Stage IV cancer patients with multiple cancer origins. The patients were classified into two groups: the first group was administered both Poly-MVA and chemotherapy, and the other group refused chemotherapy and were on the supplement only. In both groups, the Poly-MVA dosage was administered intravenously for a 15-day period. The patients were then switched to an oral dosage for up to 6-8 months. After six months, a maintenance dosage was administered, with the amount depending upon the remission of the tumor.
The study group that used both chemotherapy and Poly-MVA were treated with low doses of chemotherapy. “My approach to treating cancer uses a lower-dose fractionated chemo, or “dose dense” chemo, where you’re getting it more often but in lower doses. So you’re getting either the same amount or more chemo but its spread out so it’s less toxic to the patient. My patients have less toxicity than patients who receive the ‘sledgehammer approach,’ which is to really hit the patient hard with chemo every three-four weeks. The sledgehammer chemo patients often have severe toxicities from the chemo.”
The study results showed an overall response rate from both groups of 56 percent, which included the following responses: stable disease, partial responses and complete responses. The overall response rate in patients who received both chemotherapy and Poly-MVA supplement was 61 percent. The overall response rate in patients who received the Poly-MVA supplement only was 39 percent. Patients receiving an initial IV loading dose of Poly-MVA had a 12 percent improved response rate compared to an initial oral loading dose. (Partial reduction means a 50 percent reduction in the size of the tumor mass, and complete reduction means a disappearance of the disease resulting from a physical examination, scanning and tumor markers.) The typical oral dosage used is 40 mL or 8 teaspoons per day. Dr. Forsythe continues to track his patients and their outcomes in his ongoing studies with over 1000 patients over the past 11 years. His outcomes continue to show longer term survival and improved quality of life, over and above any conventional approaches.