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MDx/CDx Focus: Response, Taiho MDx Services Agreement; ARCA Update on Gencaro Development


Response Genetics, Taiho Extend MDx Services Pact

Response Genetics could receive up to $950,000 for molecular diagnostic testing services provided to Taiho Pharmaceutical related to the development of cancer treatments.

The deal, announced this week, extends an existing collaboration between the two companies to the end of this year.

"Response Genetics has and continues to provide Taiho with a comprehensive portfolio of gene expression assays and we are pleased to extend this relationship," Thomas Bologna, Response CEO, said in a statement. In particular, Response has been providing testing and analysis services for specific molecular markers that Taiho is using in the development of various cancer treatments.

Taiho is headquartered in Tokyo. The company markets the anticancer agent Abraxane and the orally disintegrating cancer drug TS-1 in Japan. The company is exploring genomic approaches to personalize cancer treatments.

In September of last year, Response raised $8.8 million through a private placement of stock with GlaxoSmithKline and another "existing" stockholder. The additional funds helped to bolster the company's decline in revenues from pharmaceutical clients during the first half of last year.

For the full year ended December 31, 2012, Response's total revenues decreased to $18.7 million, compared to $22.6 million in the previous year.

Response markets proprietary genetic tests and panels under the ResponseDx brand for lung cancer, colon cancer, gastric cancer, and melanoma. Last year, the firm's ResponseDX revenue decreased slightly to $11.9 million, compared to $12.5 million from 2011.

ARCA Biopharma Working with Medtronic in Phase IIb Gencaro Study

In a business update, ARCA Biopharma announced it is collaborating with Medtronic to conduct the Phase IIb portion of GENETIC-AF, a Phase IIb/III clinical trial evaluating the drug Gencaro (bucindolol) as an atrial fibrillation treatment for patients with genetic variants that might make them respond particularly well to the drug.

GENETIC-AF, a multi-center, randomized, double-blind clinical trial comparing Gencaro to metoprolol CR/XL for prevention of atrial fibrillation, will enroll approximately 200 patients in the Phase IIb portion of the trial. All patients will harbor genetic variants of the beta-1 cardiac receptor, which ARCA believes predisposes patients to respond well to Gencaro.

Researchers from Duke University Medical Center, ARCA, and elsewhere published data in PLOS One last year from a retrospective pharmacogenetic analysis showing that the combination of two polymorphisms -- beta1 AR and alpha2c AR -- can be useful in determining which patients respond especially well, have an average response, or have virtually no response to Gencaro (PGx Reporter 10/24/2012).

In the Phase IIb portion of the trial, study participants will have their heart rhythm monitored using a Medtronic device, a cardiac resynchronization or defibrillation device, or a Reveal loop recorder. In this part of the study, researchers will measure patients' actual time in atrial fibrillation regardless of their symptoms.

Depending on the interim analysis of the Phase IIb study by a Data Safety Monitoring Board, ARCA may expand the trial into Phase III, enrolling more than 400 patients. For the interim analysis, the DSMB will review data on atrial fibrillation burden and the time to recurrence of symptomatic atrial fibrillation after electrical cardioversion, or death.

ARCA expects to begin enrolling patients in the first quarter of 2014.

Separately, ARCA also said that it completed an equity offering in which it raised net proceeds of around $18 million. As of June 30, the company reported having approximately $20 million in cash and cash equivalents.