You are here
Matinas BioPharma to Present at the U.S. FDA Development of Non-Traditional Therapies for Bacterial Infections Workshop
BEDMINSTER, N.J., Aug. 16, 2018 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc. (NYSE AMER: MTNB), a clinical-stage biopharmaceutical company focused on enabling targeted intracellular delivery of life-changing medicines using its proprietary lipid nano-crystal (LNC) platform technology, announced today that Raphael Mannino, Ph.D., Chief Scientific Officer of Matinas will present at the public workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections,” being held by the U.S. Food and Drug Administration (FDA) August 21-22, 2018. The purpose of the public workshop is to discuss the general development considerations of non-traditional therapies, including preclinical development, early clinical studies, and Phase 3 clinical trial designs to evaluate safety and efficacy.
Dr. Mannino will discuss the Company’s proprietary LNC technology in a presentation entitled, “A Unique Approach to the Treatment of Intracellular Pathogens with Anti-Microbial Agents.” Matinas BioPharma's differentiated LNC drug delivery platform offers an intracellular drug delivery solution with potential advantages for a range of therapeutics, including small molecules, nucleic acid polymers, proteins, peptides, vaccines, as well as the targeted delivery of gene editing technologies.
Additionally, Dr. Mannino will provide an overview of the Company's lead and platform-validating product candidate, MAT2203, which utilizes its proprietary LNC formulation technology for the safe and effective delivery of the broad-spectrum fungicidal agent, amphotericin B. Based on the positive patient clinical data reported in 2017 and a positive face-to-face interaction with the FDA in 2018, Matinas has designed a streamlined and risk-mitigated development program focused on a potential pivotal Phase 2 trial of MAT2203 for the prevention of IFIs in patients with acute lymphoblastic leukemia. This initial indication represents a significant unmet medical need and Matinas’ unique ability to formulate a safe and effective oral formulation of amphotericin B, designed for longer term use, uniquely positions MAT2203 to become the ideal antifungal therapy for the prevention and treatment of invasive fungal infections. Matinas expects to engage with FDA frequently over the next 6-12 months as it prepares to commence its potential pivotal Phase 2 adaptive-designed study in 2019. The Company believes that orally-administered MAT2203 has the potential to become a highly differentiated therapy in the antifungal field.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing innovative medicines using its lipid nano-crystal (LNC) platform delivery technology. The Company's proprietary, disruptive technology utilizes lipid-crystal nano-particle cochleates to nano-encapsulate small molecules, oligonucleotides, vaccines and other medicines potentially making them safer, more tolerable, less toxic and orally bioavailable.
The Company's lead anti-fungal product candidate, MAT2203, positions Matinas BioPharma to become a leader in the safe and effective delivery of anti-infective therapies utilizing its proprietary LNC formulation technology.
Forward Looking Statements: This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those relating to the Company's anticipated capital and liquidity needs, strategic focus and the future development of its product candidates, including MAT2203, the anticipated timing of regulatory submissions, the anticipated timing of clinical studies, the anticipated timing of regulatory interactions, the Company’s ability to identify and pursue development and partnership opportunities for its products or platform delivery technology on favorable terms, if at all, and the ability to obtain required regulatory approval and other statements that are predictive in nature, that depend upon or refer to future events or conditions. All statements other than statements of historical fact are statements that could be forward-looking statements. Forward-looking statements include words such as "expects," "anticipates," "intends," "plans," "could," "believes," "estimates" and similar expressions. These statements involve known and unknown risks, uncertainties and other factors which may cause actual results to be materially different from any future results expressed or implied by the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to obtain additional capital to meet our liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials of our product candidates; our ability to successfully complete research and further development and commercialization of our product candidates; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; our ability to maintain and derive benefit from the Qualified Infectious Disease Product (QIDP), Orphan and/or Fast Track designations for MAT2203, which does not change the standards for regulatory approval or guarantee regulatory approval on an expedited basis, or at all; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and the other factors listed under "Risk Factors" in our filings with the SEC, including Forms 10-K, 10-Q and 8-K. Investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this release. Except as may be required by law, the Company does not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Matinas BioPharma's product candidates are all in a development stage and are not available for sale or use.
|Investor Contact||Media Contact|
|Jenene Thomas||Eliza Schleifstein|
|Jenene Thomas Communications, LLC||Scient Public Relations|
|Phone: +1 (833) 475-8247||Phone: + 1 (917) 763-8106|
|Email: email@example.com||Email: firstname.lastname@example.org|
Source: Matinas BioPharma Holdings, Inc.