BEDMINSTER, N.J., July 13, 2016 (GLOBE NEWSWIRE) -- Matinas BioPharma Holdings, Inc.(OTCQB:MTNB), a clinical-stage biopharmaceutical company focused on identifying and developing safe and effective broad spectrum therapeutics for the treatment of serious and life-threatening infections, announces the presentation today of efficacy results in animal models of cryptococcal meningitis resulting from treatment with its investigational drug, MAT2203 (orally-administered encochleated amphotericin B), under development for the treatment of serious fungal infections, at AIDS-Associated Mycoses scientific meeting being held July 13th – 15th in Capetown, South Africa.
In a presentation today at the AIDS-Associated Mycoses Meeting, scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), showed that they could effectively treat mice infected with cryptococcal meningitis in two experiments using an orally administered lipid-crystal nano-particle formulation of amphotericin B (MAT2203). In the first experiment MAT2203 administered orally was used alone after a 1-day infection incubation period and resulted in 80% survival of mice out to 60 days, which was equivalent to commercial amphotericin B deoxycholate injection and superior to the untreated control group, which showed 100% mortality at Day 20. In the second experiment, MAT2203 was administered orally with flucytosine and by injection as a stand-alone treatment after a 3-day infection incubation period and resulted in 80% survival after 70 days and 40% survival after 90 days, whereas commercial amphotericin B deoxycholate injection resulted in 20% survival after 70 days and 90 days. All treatment groups demonstrated superior survival compared to the untreated control group, which exhibited 100% mortality after 14 days.
"This study in murine models of this highly lethal medical condition of our orally administered cochleate formulation of amphotericin B, in comparison to administration of the commercial formulation of amphotericin B by injection, continues to increase our belief in the potential to deliver this powerful anti-infective at a lower toxicity and offer a new treatment option for immunocompromised patients with severe and life-threatening fungal infections," said Roelof Rongen, Chief Executive Officer of the Company. "We look forward to continue to add evidence for the broad spectrum benefit and potential of our formulation of amphotericin B utilizing our proprietary lipid-crystal nano-particle cochleate technology."
Cyrptococcal meningitis is a highly lethal fungal infection of the brain, and the incidence of this condition is strongly correlated to diseases of the immune system such as HIV/AIDS. Despite advances in the treatment HIV/AIDS it is estimated that the global burden of HIV-associated cryptococcal meningitis is more than 1-million cases annually world-wide, with an estimated global mortality of approximately 600,000 cases per year.
The Company received QIDP designations by the U.S. Food and Drug Administration (FDA) for its lead program MAT2203 for the treatment of candidida and aspergillus infections, and is enrolling a Phase 2a study in patients with chronic mucocutaneous candidiasis at NIH/NIAID.
MAT2203 is an orally-administered, encochleated formulation of amphotericin B (a broad spectrum fungicidal agent). Little to no clinical resistance has been reported to date with amphotericin B as compared to the rapidly emerging drug resistance seen in other antifungal therapies. Currently, IV-only administered amphotericin B is the only broad spectrum fungicidal available but its IV-delivery results in significant treatment-limiting side effects, including nephrotoxicity. The ability to provide amphotericin B via MAT2203’s proprietary and novel oral formulation may offer a new and promising alternative for patients and doctors. In a clinical Phase 1a single-dose, double-blind, dose-escalating, pharmacokinetic study of 48 healthy volunteers, oral MAT2203 demonstrated a positive safety and tolerability profile with no serious adverse events reported, including little or no nephrotoxicity as compared to placebo. Enrollment is currently underway for the Phase 2a NIH/NIAID-funded clinical study with MAT2203 in patients with refractory mucocutaneous candidiasis, with results expected during 2016. MAT2203 is also being explored for treatment of additional anti-fungal indications and may have the potential for Orphan Drug Designation in certain of these indications.