RECENT DEVELOPMENTS at the Institute include:
The Institute for Therapeutic Discovery has launched a long-term project to intentionally regulate the placebo response. Read the press release here.
With the opening of a new facility in Providence, RI, TITD now shares laboratory space with its sister, for-profit biopharmaceutical company, Beech Tree Labs (www.beechtreelabs.com). Four well-equipped laboratories support microbiology, immunology, chemistry, and cell culture research. Priority projects are focused on the use of low-level antibodies to treat diabetes and diabetic neuropathy, and a novel agent that addresses both influenza and herpesvirus infections.
The Institute has licensed its DNA-based nutraceutical that supports respiratory health to Allergy Research Group of California. The trade name for the product is Mucolyxir and is available to healthcare professional under the Allergy Research Group label (www.allergyresearchgroup.com) and to the general public under its NutriCology label (www.nutricology.com). Mucolyxir is the first of the Institute’s Signature Molecules™ nutraceutical product line on the market.
[ See press release... ]
Scientists at the Massey Cancer Center at Virginia Commonwealth University have validated prior laboratory research showing the efficacy of human chorionic gonadotropin (hCG) in treating cancer. Using prostate cancer cell lines, hCG was shown to radiosensitize cancer cells as well as facilitate apoptosis, or normal cell death. Prior work by Milkhaus Laboratory yielded similar results for breast cancer cell lines.
In collaboration with Milkhaus Veterinary Products, Inc., a blinded trial has been successfully completed and licensing negotiations have begun for an agent to treat horses and pigs with OCD, a defect in connective tissue of young animals that compromises their athletic performance or their ability to stand, and thus may significantly decrease an animal’s value.
In 2001, Dr. McMichael was granted a patent for an anti-viral agent that was shown to be effective in treating herpesvirus infections in humans, cattle, dogs, and cats. More recently that same product has demonstrated efficacy in the treatment of type A influenza, and another patent application has been filed.
The timeliness of this development cannot be overstated in light of the recent concern of bird flu possibly infecting humans. A formal FDA-authorized clinical trial must be conducted to move this product towards the marketplace.
Milkhaus Laboratory, Inc., licensed to Elan Corporation, plc, 31 patents related to Alzheimer’s disease that collectively afford Elan protection for its use of beta-amyloid protein to treat that disease. Alzheimer’s work at the Institute has taken a different track than that reflected by those patents and has resulted in the formulation of a product that appears to be considerably more potent than the medicine being developed by Elan. A formal proof-of-concept trial is necessary to determine the validity of early anecdotal observations.
The Institute has been working on an agent for the treatment of depression and anxiety that would have few, if any, adverse side effects. Not only does this molecule appear to be efficacious for those disorders in humans, but it also shows promise for treating dogs with separation anxiety or acute nervousness. A collaborative study with investigators at the University of North Carolina at Chapel Hill has confirmed our anecdotal results in validated laboratory animal models in which the Institute’s product compared favorably with prescription anti-depressants currently on the market.
Equally important is the Chapel Hill team’s observation that the Institute’s agent mode-of-action appears to be unique, and may therefore represent “first in class” status for this medicine. Expanded laboratory studies are now underway at UNC. Parallel to this work, a protocol is being developed for a proof-of-concept FDA trial.
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