|[April 03, 2014]
ADMA Biologics to Present Data at the 2014 Clinical Immunology Society (CIS) Meeting
RAMSEY, N.J. --(Business Wire)--
ADMA Biologics, Inc. (OTCQB:ADMA), a late-stage biopharmaceutical
company that develops, manufactures, and intends to market specialty
plasma-based biologics for the treatment and prevention of certain
infectious diseases, today announced that its abstract titled "POLYCLONAL
HUMAN INTRAVENOUS IMMUNE GLOBULIN (IGIV) WITH HIGH-LEVELS OF RSV
NEUTRALIZING ANTIBODIES: A SUMMARY OF ANIMAL AND HUMAN STUDIES" was
accepted for a poster presentation during the 2014 Clinical Immunology
Society (CIS) meeting.
"The data being presented at the 2014 CIS meeting support the further
development of ADMA's lead product candidate (RI-002) for the prevention
and treatment of RSV disease in the immune suppressed population,"
stated James Mond, M.D., Ph.D., Chief Medical & Scientific Officer for
The 2014 CIS Annual Meeting: Primary Immune Deficiency Diseases North
American Conference will take place April 10 - 13, 2014 at the Hilton
Baltimore. Representatives from ADMA Biologics will be in attendance at
this meeting. CIS is the key inter-disciplinary organization for the
field of clinical immunology and is devoted to fostering developments in
the science and practice of clinical immunology. The mission of CIS is
to facilitate education, translational research and novel approaches to
therapy in clinical immunology and to promote excellence in the care of
patients with immunologic/inflammatory disorders.
About ADMA Biologics, Inc.
ADMA is a late stage biopharmaceutical company that develops,
manufactures, and intends to market specialty plasma-based biologics for
the treatment and prevention of certain infectious diseases. ADMA's
mission is to develop and commercialize plasma-derived, human immune
globulins targeted to niche patient populations for the treatment and
prevention of certain infectious diseases. The target patient
populations include immune-compromised individuals who suffer from an
underlying immune deficiency disease or who may be immune-compromised
for medical reasons. ADMA also operates ADMA Bio Centers, an
FDA-licensed and GHA-certified source plasma collection facility located
in Norcross, Georgia, which rovides ADMA with a portion of its blood
plasma for the manufacture of RI-002. For more information please visit
the Company's website at www.admabiologics.com.
About ADMA's lead product candidate RI-002
ADMA's lead product candidate, RI-002 is a specialty plasma-derived,
polyclonal, Intravenous Immune Globulin, or IGIV, derived from human
plasma containing naturally occurring polyclonal antibodies (eg.
streptococcus pneumoniae, H. influenza type B, CMV, measles, tetanus
etc.) as well as high levels of antibodies targeted to respiratory
syncytial virus, or RSV. ADMA is pursuing an indication for the use of
this specialty IGIV product for treatment of patients diagnosed with
primary immune deficiency diseases, or PIDD. Polyclonal antibodies are
the primary component of IGIV products. Polyclonal antibodies are
proteins produced by B-cells that are used by the body's immune system
to neutralize microbes such as bacteria and viruses. The polyclonal
antibodies that are present in RI-002 are expected to prevent infections
in immune-compromised patients. The product is currently being evaluated
in a Phase III trial in the United States.
Cautionary Statement Regarding Forward-Looking Information
This press release contains "forward looking statements."
Forward-looking statements include, without limitation, any statement
that may predict, forecast, indicate, or imply future results,
performance or achievements, and may contain the words "estimate,"
"project," "intend," "forecast," "target," "anticipate," "plan,"
"planning," "expect," "believe," "will," "will likely," "should,"
"could," "would," "may" or, in each case, their negative, or words or
expressions of similar meaning. These forward-looking statements
include, but are not limited to, statements concerning the timing,
progress and results of the clinical development, the availability of
preliminary data, the reporting of data, regulatory processes, potential
clinical trial initiations, potential investigational new product
applications, biologics license applications, expansion plans, the
achievement of clinical and regulatory milestones, build out, opening
and regulatory approval of plasma facilities, commercialization efforts
of the Company's product candidate(s) and the potential listing on the
NASDAQ Market. Forward-looking statements are subject to many risks and
uncertainties that could cause our actual results to differ materially
from any future results expressed or implied by the forward-looking
statements, including, but not limited to, the risks listed under the
heading "Risk Factors" in our Annual Report on Form 10-K for the year
ended December 31, 2013, as filed with the U.S. Securities and Exchange
Commission on March 28, 2014 and our other filings with the U.S.
Securities and Exchange Commission including, among other things, risks
as to whether any preliminary data will, if and when available, be
encouraging, positive or will otherwise lead to an effective or approved
product, whether we will be able to demonstrate efficacy or gain
necessary approvals to market and commercialize any product, whether we
will meet any of our clinical or regulatory milestones, open any new
facilities, successfully list our securities on the NASDAQ Market and
whether we will meet any timing targets expressed by the Company.
Therefore, current and prospective security holders are cautioned that
there also can be no assurance that the forward-looking statements
included in this press release will prove to be accurate. In light of
the significant uncertainties inherent to the forward-looking statements
included herein, the inclusion of such information should not be
regarded as a representation or warranty by ADMA or any other person
that the objectives and plans of ADMA will be achieved in any specified
time frame, if at all. Except to the extent required by applicable laws
or rules, ADMA does not undertake any obligation to update any forward
looking statements or to announce revisions to any of the
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