Company aims for easier diagnosis, treatments
This article is reprinted with permission from the CFIDS Chronicle, Vol. 11, No. 3 May/June 1998.
A new clinical research/laboratory has begun operations in Brussels, Belgium, to continue the CFIDS research of Drs. Robert Suhadolnik and Kenney De Meirleir toward developing a diagnostic kit and therapies for the unique protein abnormality the doctors have been studying.
R.E.D Laboratories obtained investment capital commitments in December and was formed in February. It offers diagnostic screening for the biochemical abnormality they call RNaseL Enzyme Dysfunction Disease (REDD).
The name REDD stems from Dr. Suhadolnik’s discovery of a specific protein abnormality within the white blood cells of some CFIDS patients. This defect is located in the enzymatic pathway that controls an individuals’ ability to fight viral infection. The development of the diagnostic test for this marker allows doctors to identify those in this subset of CFIDS patients and allows researchers to focus on finding therapies to treat it.
Diagnostic kit planned
R.E.D Laboratories has set its initial research effort “to further validate this protein as a marker for REDD, to clinically define REDD as a subset of CFIDS, to develop a diagnostic kit for use worldwide, and to develop therapies targeting this protein abnormality,” according to managing director C.V. Hearst.
The company is currently accepting preparations of peripheral blood monoclonal cells (pellets) for testing. However, the preparation of these pellets is time consuming and difficult, requiring storage at extremely low temperatures and shipment on dry ice. The company hopes to quickly develop antibodies specific for the defective protein and to assemble a kit containing the necessary materials so that labs around the world could administer the test.
The therapeutic research, to begin next year, will target the defective protein. “By stopping its action or by decreasing the amount of low molecular weight protein present in the cell, the immune system may re-stabilize itself,” according to R.E.D. Laboratories’ Corporate Profile, a document for investors. While research will continue to determine the origins of the defective protein, the company expects to work initially with other pharmaceutical firms who believe they make a drug to treat such a disease.
Drs. Suhadolnik, Peterson play role
The company’s Scientific Advisory Board is led by Dr. Suhadolnik, professor of biochemistry at Temple University medical School in Philadelphia, who has spent 10 years investigating the 2’-5’ A synthetase RNaseL antiviral pathway and the abnormal proteins at work there. The board also includes DR. Bernard Lebleu of France, a molecular geneticist who replicated Dr. Suhadolnik’s findings, and Dr. Daniel Peterson, an internist who treats CFIDS patients in Incline Village, Nev., and has worked closely with Dr. Suhadolnik. (Grants from The CFIDS Association of America assisted Dr. Suhadolnik and paid for Lebleu’s replication study in the effort to validate this potential marker.)
Financial backing comes from Quadra Invest NV, a Belgian venture capital firm. Herst said he had hoped to set up the company in the United States, but the investment banks he approached had no interest in CFIDS – both because it is still considered a new disease and because reimbursements for clinical labs here are at an all-time low. He teamed up with Dr. Kenny De Meirleir, professor of medicine at the Vrije University, Brussels, after learning of his interest in setting up a lab in Brussels.
Testing related to Ampligen
R.E.D. Laboratories is currently working out an agreement with Hemispherx Biopharma, the makers of Ampligen, to provide testing related to Hemispherx’s plans to increase the availability of Ampligen and to undertake a Phase III trial of the drug for treating CFIDS. Spokesmen for Hemispherx have said the company’s recent experience with Ampligen suggests it is most effective for those patients who test positive for the RNaseL defect. Herst said he is hopeful the REDD test will help to define how Ampligen works.
Herst said he sees CFIDS as similar to cancer – multiple causes, clinical presentations and genetic factors mean multiple treatments will be necessary. However, he said, “CFIDS research is where cancer research was 30 years ago.” There are a few tests for specific, suspected causes of CFIDS symptoms and a number of treatments that are either non-specific or undefined as to how or for whom they work.
In suggesting that REDD might be one form of CFIDS and that Ampligen may be a start toward treatment, Herst said for-profit companies may be in a position to take advantage of their ability to raise capital and advance research into CFIDS.