|[March 07, 2013]
ADMA Biologics Commences Pivotal Phase III Clinical Study of RI-002 in PIDD Patients
HACKENSACK, N.J. --(Business Wire)--
ADMA Biologics, Inc. (ADMA), a specialty immune globulin company that
develops, manufactures and intends to market plasma-based biologics for
the treatment and prevention of certain infectious diseases, announced
that the first patient enrolled in the pivotal Phase III clinical study
of its RI-002 has been dosed. This study is designed to evaluate the
efficacy and safety of RI-002 as a novel immune globulin for the
treatment of patients who suffer from Primary Immune Deficiency Diseases
The trial is being conducted in accordance with the U.S. Food and Drug
Administration (FDA) published guidance for the industry (June 2008) and
intends to evaluate RI-002 in an aggregate of between 60 and 70 patients
diagnosed with PIDD, for a 12-month treatment period followed by up to
90 days of safety monitoring and follow-up. ADMA anticipates enrolling
patients at investigative centers across the United States.
"We are excited to be working with leaders in the PIDD community to
evaluate the safety and efficacy of RI-002," said Adam S. Grossman,
President and Chief Executive Officer of ADMA. "RI-002 will offer PIDD
patients additional treatment options, while providing clinicians who
see all types of immune deficient patients with greater flexibility."
"It is encouraging to see a company like ADMA Biologics championing a
specialty immune globulin product for the PIDD patient community. Having
access to a specialty, high titer immune globulin product such as
RI-002, indicated for use in the PIDD population would be a welcome
addition to currently available therapies," said Dr. Richard L.
Wasserman, Clinical Professor of Pediatrics, University of Texas
Southwestern Medical School and Lead Principal Investigator of ADMA's
Phase III trial.
Further information about ADMA Biologics can be found by visiting the
Securities and Exchange Commission website www.sec.gov
and can also be viewed on the company's website at: www.admabiologics.com.
About ADM'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.
About Primary Immune Deficiency Disease (PIDD)
PIDD is a class of inherited genetic disorders that causes an individual
to have a deficient or absent immune system due to either a lack of
necessary antibodies or a failure of these antibodies to function
properly. PIDD patients are more vulnerable to infections and more
likely to suffer complications from these infections. According to the
World Health Organization, there are over 150 different presentations of
PIDD. As patients suffering from PIDD lack a properly functioning immune
system, they typically receive monthly, outpatient infusions of IGIV
therapy. Without this exogenous antibody immune support, these patients
would be susceptible to a wide variety of infectious diseases. PIDD has
an estimated prevalence of 1:1,200 in the United States, or
approximately 250,000 people.
About ADMA Biologics, Inc.
ADMA is a specialty immune globulin company that develops, manufactures
and intends to market 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, which is an FDA-licensed source
plasma collection facility located in Norcross, Georgia, which provides
us with a portion of our blood plasma for the manufacture of RI-002. www.admabiologics.com
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," "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, regulatory processes, potential clinical trial
initiations, potential investigational new product applications,
biologics license applications, and commercialization efforts of the
Company's product candidate(s). 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, 2012. 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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