Test for the weary

Chronix Biomedical and Hemispherx Biopharma join forces to develop diagnostic test for Chronic Fatigue Syndrome

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SAN JOSE, Calif.—Chronix Biomedical and Hemispherx Biopharma Inc. recently announced they have jointly filed a provisional U.S. patent application on a blood test for Chronic Fatigue Syndrome (CFS).

Those with CFS suffer from a wide range of symptoms, including cognitive deficiencies, swollen lymph nodes and the inability to overcome fatigue by rest. The Centers for Disease Control and Prevention (CDC) estimates that about 4 million Americans suffer from CFS.

According to the CDC website, no specific diagnostic tests are available, and a CFS diagnosis is based on a patient having severe chronic fatigue "for at least six months or longer that is not relieved by rest and not due to medical or psychiatric conditions." Patients must also exhibit having four or more of the following symptoms concurrently: muscle pain, frequent or recurring sore throat, multi-joint pain without swelling or redness, headaches, tender cervical or axillary lymph nodes, unrefreshing sleep, post-exertional malaise that lasts more than 24 hours and severe self-reported impairment of short-term memory or concentration.

Current testing options include a variety of methods, with some of the most popular versions consisting of a bioassay and another that focuses on a biochemical deficiency. The problem, says Dr. William Carter, Hemispherx's CEO, is these current testing options don't predict the disease "with the high accuracy that one would want."

Chronix's approach consists of analyzing fragments of DNA that are released into the bloodstream during cell death, or apoptosis. Through its proprietary technology and DNA sequencing platforms, Chronix can measure alterations in different regions of chromosomes. By studying those alterations, their technology can detect disease-damaged cells in standard blood samples.

"Our technology—based on DNA released into the bloodstream by dying and damaged cells—taps into the dynamic information provided by the genomic alterations unique to each diseased cell," says Howard Urnovitz, CEO, chief science officer and co-founder of Chronix. "We capture what is happening to the DNA very early in and throughout the disease process, in real time, and patient by patient."

"The circle seems to be closing," adds Carter, "but we feel that Howard's new method is the future."

The birth of this partnership took place about 10 years ago. Urnovitz says he contacted originally Carter to inform him that Chronix had made a discovery with its biomarker platform, and that that was when "we agreed to start a program to look and see if we could not create a technology that would allow for biomarkers in diseases like CFS."

Urnovitz says Chronix brings "expertise in developing biomarkers technology for genetics" to the table, and credits Hemispherx with providing clinical experience, a large repository of clinical samples and "a good relationship with the FDA."

Carter echoes this sentiment, noting that Hemispherx has "a large inventory of lab specimens from a very well-studied population of individuals suffering from CFS."
"We have been active in this area for more than a decade and evaluated more than 1,000 subjects who have the condition CFS," says Carter. "This constituted a great opportunity to use Howard's new technology to study these specimens in an effort to see if we could come up with new diagnostic insight."

Now that they have proof of concept, Urnovitz says the next step in the process will be a large clinical trial, and the companies are aiming for at least 500 samples from individuals suffering from CFS. Urnovitz notes that "Hemispherx has many great resources for a diagnostic company" like Chronix, particularly in terms of quality and quantity of clinical samples. It will take the partners some time to select which samples they want to test, Urnovitz adds, and they will begin once they have the samples selected and have agreed upon the "how the project goes forward."

Once it does, Carter says the studies will be "aimed at validating the utility of the Chronix technology to identify how different individuals can respond to Hemispherx's experimental drug Ampligen." The two companies will be evaluating Chronix's diagnostic technology in clinical studies in terms of identifying CFS biomarkers.

"There's a call for better biomarkers. What we found was that we are now moving towards validating the concept that CFS is a disease that can be defined as damage to a very specific part of the human genome," says Urnovitz. "We believe that we can find the biomarkers unique to CFS and each individual."

Looking to the future, Carter notes that in terms of commercialization, they are "looking to individualize the therapy based on the specific genetic damage that's occurred."
Urnovitz echoes that aim, identifying the commercial opportunities as being "two-fold, diagnostic and pharmaceutical."

"(CFS) needs a reliable biomarker, because until recently, many people thought it was a psychosomatic condition," Carter asserts. "It's a disorder that's begging for reliable biomarkers."

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