Biocept and Catalyst Pharmaceuticals Collaborate to Provide Liquid Biopsy Testing for Small Cell Lung Cancer to Patients with Lambert Eaton Myasthenic Syndrome (LEMS)

SAN DIEGO, March 14, 2017 /PRNewswire/ -- Biocept, Inc. (NASDAQ: BIOC), 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."

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer. The Company's patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient's disease and therapeutic options. For additional information, please visit www.biocept.com.

About Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases. Catalyst is developing amifampridine phosphate for the treatment of LEMS, a rare neuromuscular, autoimmune disorder frequently associated with SCLC. Catalyst also believes that amifampridine phosphate has the potential to treat other neuromuscular disorders such as congenital myasthenic syndromes and some cases of myasthenia gravis that are refractory to currently approved therapies. Catalyst is also developing a highly potent GABA-aminotransferase (GABA-AT) inhibitor, designated CPP-115, for the treatment of infantile spasms, a rare form of debilitating epileptic seizures that presents in infants. For more information, visit www.catalystpharma.com. Follow Catalyst on Twitter at www.twitter.com/catalystpharma.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like "may," "will," "should," "could," "expect," "anticipate," "estimate," "believe," "intend," or "project" or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the outcomes of cancer patients, , and our ability to validate the clinical utility of our liquid biopsy platform, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC's website located at www.sec.gov.

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SOURCE Biocept, Inc.