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By Omar Ford

Staff Writer

It's no secret that pharma has been seeking out companies in the diagnostics space for partnerships. The increased interest from pharma centers on the current push towards personalized medicine in health care. Companies are looking to gain greater insight on how drug therapies could impact patients. The latest 'high profile' pairing comes via Exalenz Bioscience (TASE:EXEN) (Modi'in, Israel) and Galectin Therapeutics (NASDAQ:GALT) (Norcross, Ga.).

The companies are working on a therapy that could lead to a better treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis (NASH Cirrhosis). To accomplish this, Galectin Therapeutics will use Exalenz Bioscience's BreathID test to monitor patients in a Phase II study evaluating GR-MD-02 as an investigational treatment for patients with cirrhosis associated with nonalcoholic steatohepatitis.

The collaboration is great for both companies, as Galectin will get the chance to see the impact its GR-MD-02 therapy has on patients and Exalenz will get a chance to see its test's effectiveness in measuring the liver and metabolic function.

"The Exalenz breath test results are being used as a secondary endpoint in the Galectin study to monitor the effect of the Galectin drug," Raffi Werner CEO of Exalenz, told Medical Device Daily. "The breath test gives a diagnostic measure of liver metabolic function. The expectation is to see liver function improvement in patients that respond to the Galectin drug."

To take part in the study, Exalenz received an IDE from the FDA. Separately, the BreathID is FDA cleared for diagnosis of Helicobacter pylori, (H. pylori). The device is also cleared for H. pylori in Europe, China and other countries.

There are about 156 patients in Galectin's study. The enrolled participants will receive three breath-based tests: the first will be given during the screening stage, the second will be given at week 25 of treatment and the third will be given after the final dose of GR-MD-02.

"Exalenz expects to serve the market of patients requiring a non-invasive diagnostic to check both their suitability to use NASH related drugs, as well as monitoring the effects of these drugs," Werner said. "The breath test must be validated clinically with each specific drug, Galectin being the first. Due to the ease of use and non-invasive nature of the breath test, we expect wide usage for NAFLD patients, which are estimated to be 10% of the U.S. population, with similar numbers in most of the [Organization for Economic Cooperation and Development]."

He added, "The approval of a diagnostic related to the Galectin drug is dependent on the approval of the Galectin drug itself, therefore we cannot comment on timelines. In addition to the collaboration with pharma companies, Exalenz is developing liver diagnostic applications on its own, and is in the clinical study phase. Depending on the success of these studies, Exalenz will expand the trials and prepare for FDA approval. This is estimated for 2017 to 2018."

BreathID technology measures the level of change of 1C labeled urea detectable in a patient's breath. This is measured before and after the ingestion of a low dosage of 13C labeled urea dissolved in water or orange juice. The test is non-radioactive.

Collaborations plentiful between pharma and diagnostic companies

Partnerships between diagnostics companies and pharma companies have created a market that is worth $42 billion, according to a report from Research and Markets. The report said that the realization that companion diagnostics can decrease costs by identifying the patient population that will most likely benefit from a therapy and rule out those therapies not likely to be effective, has made companion diagnostics important to the delivery of care.

Pharma and diagnostics companies are catching on to this idea quickly. In the last few months there have been a number of collaborations.

In June, Roche's (Basel, Switzerland) Ventana Medical Systems (Tucson) received FDA approval of its Ventana ALK (DF53) as a companion diagnostic for Pfizer's (NYSE: PFE) (New York) Xalkori to treat non-small cell lung cancer.

In May, Cypher Genomics (San Diego) reported that it had formed a partnership with Celgene (NASDAQ: CELG) (Summit, N.J.) to help uncover genetic biomarkers that help match patients to a suitable therapy.

Back in April Myriad Genetics (NASDAQ:MYGN) (Salt Lake City) reported that it expanded its companion diagnostics partnership with Astrazeneca (NYSE: AZN) (London). The pharma company will use Myriad's BRACAnalysis test to see which metastatic pancreatic cancer patients respond to Lynparza (olaparib).




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