Seneca Biopharma Announces Results of Meeting with FDA Regarding the Design of Phase 3 Trial for NSI-566 in ALS

GERMANTOWN, Md., April 9, 2020 /PRNewswire/ -- Seneca Biopharma, Inc. (Nasdaq: SNCA), a clinical-stage biopharmaceutical company focused on developing novel treatments for diseases of high unmet medical need, today announced that the company held a Type C meeting with the Office of Tissues and Advanced Therapies at the FDA on March 10, 2020 to discuss future clinical development plans for NSI-566, the company's leading neural stem cell therapy candidate, for the treatment of patients with amyotrophic lateral sclerosis (ALS). As a result of the discussion and feedback received from the FDA, Seneca believes that the existing phase 1 and 2 trial results support moving into a phase 3 clinical study for ALS.

"This represents a major step forward in getting our potentially beneficial therapy to patients who suffer from this devastating disease," said David Recker, M.D., Chief Medical Officer for Seneca. "We received significant guidance from FDA regarding an acceptable trial design and are in the process of developing the protocol for further review."

"We are very pleased with the outcome of the discussions," said Dr. Ken Carter, Executive Chairman of Seneca. "We look forward to working closely with the Agency on finalizing the design of a Phase 3 trial for this devastating disease."

NSI-566 has received orphan drug designation in the US for the treatment of ALS.  Orphan drug designation offers the sponsor various incentives, including tax credits for qualified clinical testing and extended marketing exclusivity. 

About ALS

ALS is a universally fatal disorder that causes progressive paralysis and eventually death from respiratory failure. Though it is rare, ALS is the most common form of motor neuron disease, with approximately 6,000 new cases diagnosed every year in the US.  In 2018 the Centers for Disease Control and Prevention reported that there were between 16,000 and 17,000 individuals in the US with ALS.

About Seneca Biopharma, Inc.

Seneca Biopharma, Inc., is a clinical-stage biopharmaceutical company developing novel treatments for diseases of high unmet medical need. The Company is in the process of transforming the organization through the acquisition or in-licensing of new science and technologies, to develop with the goal of providing meaningful therapies for patients. 

NSI-566 is a stem cell therapy being tested for treatment of paralysis in stroke, ALS, and chronic spinal cord injury (cSCI).

Cautionary Statement Regarding Forward Looking Information:

This news release contains "forward-looking statements" made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as "expect," "anticipate," "intend," "plan," "believe," "seek" or "will." Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Seneca's periodic reports, including its Annual Report on Form 10-K for the year ended December 31, 2019, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

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SOURCE Seneca Biopharma, Inc.

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