By Frances Bishopp
With the development of Perthon, Advanced Plant Pharmaceuticals Inc. has taken an ancient medical approach to a 20th century disease.
Perthon is derived exclusively from whole plants, as are the other products currently being developed by Advanced Plant Pharmaceuticals (APPI) and has been demonstrated to overcome many of the debilitating symptoms of AIDS. The product works by strengthening the immune system to deal with the virus or to help prevent it from forming.
According to in vitro studies, Perthon has demonstrated such results as reversal of glandular swelling, restoration of well being and associated weight gain, improvement in response to skin hypersensitivity tests, and increase in the circulating concentration of helper T cells (CD4-positive cells). Associated with this increase is an improvement in the CD4/CD8 ratio, with many patients returning to a normal ratio.
APPI is completing the manufacturing process of its second batch of Perthon for use in the FDA-approved Phase I/II clinical trials. In vitro immunological studies and quality controls have been initiated and will be completed during the first quarter of 1997. The Phase I/II clinical trials will begin at a university during the second quarter.
Leonard Bielory, scientific director at APPI, told BioWorld Today, the company hopes to enroll more than 40 individuals over the course of the Phase I/II trial, all of whom will take the drug. The protocol allows for a certain conventional standard of care, such as AZT treatment, but does not allow certain mechanisms of anti-viral treatment such as protease inhibitors or reverse transcriptases. "The most ideal situation would be a patient who takes no other drugs," Bielory said
In 1994, the FDA approved APPI's investigational new drug application for Perthon, which is derived from approximately 11 different plants. APPI is the first company, it claims, to receive FDA approval to proceed with development of a drug derived entirely from plants.
Other drugs in the marketplace work as blockers or inhibitors, Sam Berkowitz, office manager at APPI, told BioWorld. "Our product is actually an immuno builder. We plan to proceed further with it after Phase III to apply it to cancers as well," Berkowitz said.
The plants, which come from all over the world, are dried, ground and then blended into various proprietary combinations.
"One of the beauties of our products," Berkowitz said, "is we use whole plants, so the body, when it ingests the product, feels it is taking in a food substance as opposed to a foreign substance. It does drastically help reduce any side effects."
"This is a growing area of interest to a lot of people, taking alternative medications for holistic approaches," Bielory said. "And as such, going back to some older text investigating the possibility of what they observed may have been true. For example, Digitalis is a classic botanical. People used to chew on it to help their cardiac disease."
APPI, of New York, was incorporated as Pharmakan USA in 1989. The company, which began in Australia in 1985 as a research program to study the use of whole plants as a source of pharmaceutical products, has gone through several management and name changes over the years. Founders believed that plants would provide a safer and less expensive product with fewer side effects than chemical-based compounds.
Currently, APPI has five on its staff, but employs a number of both clinical and staff consultants, Berkowitz, said.
Other products in the APPI pipeline include Leuknil, a whole plant product used for the treatment of leukemia and cancer and LMH-123, for the treatment of Alzheimer's disease. APPI has submitted patents on both of these products.
Another whole plant product, Metachol/LoChol, for use as a natural cholesterol reducing remedy, is about to go on the market and APPI is in negotiations with a number of different distribution outlets. Metachol/LoChol has demonstrated success in lowering total cholesterol while increasing HDL, Berkowitz said. "This product will be a dietary supplement, an over-the-counter product which, hopefully, will be on the shelves by the end of March or beginning of April," Berkowitz said. *