Matinas BioPharma Holdings, Inc. (NYSE MKT:MTNB), a clinical-stage
biopharmaceutical company focused on developing innovative
anti-infectives for orphan indications, today announced the
presentation of preclinical efficacy data at The American Society
for Microbiology’s ASM Microbe 2017 Conference, demonstrating its
lead anti-infective product candidate MAT2203, which utilizes the
Company’s proprietary cochleate lipid-crystal nano-particle drug
delivery technology, exhibits positive results as an effective oral
anti-fungal agent for the treatment of cryptococcal
meningoencephalitis.
Cryptococcal meningoencephalitis (CM) is an
important infection in immunocompromised patients, including
HIV/AIDS, that is responsible for an estimated half million deaths
annually. Amphotericin B deoxycholate is a broad-spectrum
fungicidal drug that is the standard treatment for cryptococcal
disease, however, its use is limited by toxicities and intravenous
administration. MAT2203 is the Company’s orally-administered,
encochleated formulation of amphotericin B (“CAMB”), which has a
novel mechanism of absorption and distribution to infected tissues
and has the potential to transform the way this potent fungicidal
agent is administered and used in clinical practice.
Raphael Mannino, Ph.D., Chief Scientific Officer
of Matinas presented the abstract titled, “Efficacy of Oral
Encochleated Amphotericin B (CAMB) in a Mouse Model of Cryptococcal
Meningoencephalitis,” in a poster session as a part of the
Antimicrobial Pharmacokinetics: Antifungal PK/PD Studies track at
The American Society for Microbiology’s ASM Microbe 2017 Conference
being held June 1–5 in New Orleans, LA. The poster includes data
from two experiments in mouse models of cryptococcal
meningoencephalitis, the first is a model of survival and the
second is a model of delivery of MAT2203 to the brain tissue.
To access the poster, click here.
“Data from the two experiments presented in the
poster demonstrate that MAT2203 retains the broad spectrum
fungicidal activity of amphotericin B after oral administration and
the unique tissue targeted penetration of MAT2203,” said Roelof
Rongen, Chief Executive Officer. “The mortality results are
consistent with what we have seen in models of invasive candidiasis
and invasive aspergillosis and the fluorescence images of brain
tissue further support the unique ability of cochleates to
penetrate deep into infected organs.”
In the mortality experiment mice inoculated with
C. neoformans were randomized to one of seven treatment groups:
MAT2203, MAT2203 + Fungizone, Fungizone + flucytosine, flucytosine,
fluconazole, MAT2203 + fluconazole, or control. Therapy was delayed
72 hours post-inoculation and then daily treatment commenced for 28
days and mice were followed for up to 150 days and sacrificed when
moribund. The primary endpoint of this study was mortality. Results
showed that MAT2203 combined with flucytosine was able to match the
efficacy of the guideline recommended therapy for cryptococcal
meningitis in humans, Fungizone injection combined with flucytosine
(MAT2203 + flucytosine 102 d vs. Fungizone + flucytosine 80 d,
p=0.44). Both groups were superior to untreated control (19
d, p=0.003). MAT2203 (49 d), fluconazole (53 d), flucytosine
(47 d), MAT2203 + fluconazole (56 d) and were also superior to
control (p=0.003).
The second experiment evaluated the ability of
MAT2203 to penetrate into brain tissue of infected mice compared to
non-infected mice. Two groups of three mice were included in the
experiment. One group was infected as above and the other group was
left un-infected. In each group, a subset of animals was treated
orally with Rh-MAT2203 (fluorescently labeled MAT2203) for 3 days,
while another subset was untreated. Evidence of infection with
yeast cells was clearly visible by phase contrast microscopy in
animals infected with C. neoformans whereas un-infected animals
showed no evidence of yeast cells. Flourescence imaging
demonstrated the presence of Rh-MAT2203, which was clearly more
visible in the brain tissue of infected mice treated with
Rh-MAT2203 compared to the uninfected mice treated with Rh-MAT2203.
This demonstrates the ability of MAT2203 to penetrate into the
brain tissue of mice infected with C. neoformans.
The U.S. Food and Drug Administration (FDA) has
designated MAT2203 as a Qualified Infectious Disease Product (QIDP)
with Fast Track status for the treatment of invasive candidiasis,
aspergillus, and prevention of invasive fungal infections in
patients of immunosuppressive therapy. MAT2203 is also being
explored for treatment of additional infections including
cryptococcal meningoencephalitis, and is being developed to be
eligible for Orphan Drug designations in various indications.
About MAT2203
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 orally using our proprietary and novel oral
formulation may offer a new and promising alternative for patients
and doctors. Currently, there are two Phase 2 studies underway with
MAT2203. The first is an open-label Phase 2a
NIH/NIAID-sponsored clinical study with MAT2203 in
immunocompromised patients with refractory mucocutaneous
candidiasis. The second is a Phase 2 study of MAT2203 in patients
with vulvovaginal candidiasis (VVC). Data from both studies is
expected to be announced in June of 2017. The FDA has
designated MAT2203 as a Qualified Infectious Disease Product (QIDP)
for the treatment of invasive candidiasis and the treatment of
aspergillosis, as well as for the prevention of invasive fungal
infections due to immunosuppressive therapy. 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.
About Matinas BioPharma
Matinas BioPharma is a clinical-stage
biopharmaceutical company focused on developing innovative
anti-infectives for orphan indications. The Company's proprietary,
disruptive technology utilizes lipid-crystal nano-particle
cochleates to nano-encapsulate existing drugs, making them safer,
more tolerable, less toxic and orally bioavailable.
The Company's lead anti-infective product
candidates, MAT2203 and MAT2501, position Matinas BioPharma to
become a leader in the safe and effective delivery of
anti-infective therapies utilizing its proprietary lipid-crystal
nano-particle cochleate formulation technology. For more
information, please visit www.matinasbiopharma.com and connect with
the Company on Twitter, LinkedIn, Facebook, and Google+.
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 strategic focus and the
future development of its product candidates, including MAT2203 and
MAT2501, the anticipated timing of regulatory submissions, the
anticipated timing of clinical studies, 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 and MAT2501, 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
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: jenene@jenenethomascommunications.com