Biocept, Inc., a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of cancer patients, announces a collaboration with Catalyst Pharmaceuticals for the provision of Biocept's Target Selector™ platform to screen patients diagnosed with LEMS for early onset or recurrence of small cell lung cancer (SCLC). Specifically, Biocept's liquid biopsy tests will be offered by Catalyst Pharmaceuticals at no cost to all patients enrolled in its ongoing Phase III clinical trial designed to demonstrate the safety and efficacy of Firdapse® (amifampridine phosphate) for the treatment of LEMS. These patients will also have access to Biocept's liquid biopsy testing in the long-term extension study phase of the trial allowing for testing every six months for up to two years to monitor for early signals of SCLC. Terms of the agreement were not disclosed.
LEMS is a rare autoimmune disease with primary symptoms of muscle weakness, fatigue, muscle aches and autonomic dysfunction, such as impotence, dry mouth and constipation. LEMS is estimated to affect approximately 3,000 individuals in the United States. About 50% of patients have a paraneoplastic form of LEMS often associated with SCLC and, in approximately 90% of patients with this form of LEMS, a tumor was detected within two years following diagnosis. Therapy for LEMS includes the use of symptomatic treatments, as well as anti-tumor treatment with chemotherapy, immunotherapy, or kinase inhibitors if an underlying malignancy is determined.
"Catalyst's focus is on providing all LEMS patients with access to an approved treatment while identifying other ways that we can offer benefits," said Gary Ingenito, MD, PhD, Chief Medical Officer of Catalyst Pharmaceuticals. "We see Biocept's technology being of great benefit for patients with LEMS and have decided to offer advanced liquid biopsy screening to LEMS patients enrolled in our late-stage trial for Firdapse®. About half of LEMS patients have an underlying cancer associated with their disease, and we understand that this can be a source of patient anxiety. Therefore, we are taking the extra step to enable our patients to determine if they express circulating tumor cells, so that further assessment can be performed."
"One of our priorities is to enter into collaborations with pharmaceutical and biotechnology companies to aid in the development of new therapies, and to validate the clinical utility of our liquid biopsy platform," said Michael Nall, Biocept's President and Chief Executive Officer. "Our agreement with Catalyst Pharmaceuticals provides an opportunity to utilize our Target Selector™ CTC tests to screen a high-risk patient population and to identify those with early-stage disease enabling them to seek treatment as soon as possible. We look forward to working with Catalyst Pharmaceuticals, and the potential to help their patients with LEMS achieve better health outcomes."