RAMSEY, N.J., Nov. 10, 2014 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), announced today that it will be presenting data describing the composition and efficacy in an animal model of its polyclonal IVIG product, RI-002, at the 9th International Respiratory Syncytial Virus (RSV) Symposium, in Cape Town, South Africa. The abstract is titled: "Treatment of Normal and Immune Suppressed Cotton Rats with IVIG Containing High Titer Neutralizing Anti-RSV Antibody."
"The data on RI-002 demonstrated a 99.9% reduction in viral load in both the lung and nasal tissue of cotton rats, an animal model regarded as a surrogate model for human responses to RSV infection," stated Jimmy Mond, M.D., Ph.D., Chief Medical and Scientific Officer for ADMA Biologics. "RI-002 not only eliminated viral load in the lung and nasal tissue but also significantly reduced RSV dissemination to the peripheral organs in the immune suppressed animals, as measured by PCR analysis. Further laboratory analysis of the composition of RI-002 demonstrated that the product contains not only high antibody titers to RSV but also contains significantly elevated levels of antibodies to other respiratory viruses."
The presentation will include:
- Whole blood analysis data on the immune suppressed cotton rats
- RI-002 prevents RSV infections in the lungs of immune suppressed cotton rats
- Reduction of viral load in the lungs of normal and immune suppressed cotton rats treated with RI-002
- RI-002 reduces RSV dissemination to peripheral organs
- Histopathology of the lungs of RI-002 treated normal and immune suppressed cotton rats
- Antibody titer composition; Comparison of antibody levels to other respiratory viruses in RI-002 and standard IVIG
9th International RSV Symposium, Cape Town, South Africa, November 9-12, 2014
Abstract ID # 121 / Poster Presentation # 78
Title: Treatment of Normal and Immune Suppressed Cotton Rats with IVIG Containing High Titer Neutralizing Anti-RSV Antibody
Data Summary: RI-002 induced a 99.9% reduction in viral load in both lung and nasal tissue of normal and immune suppressed cotton rats with the reduction being slightly greater in the tissues of normal animals. RI-002 is manufactured to contain naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B etc.) as well as standardized, high levels of neutralizing RSV antibodies and was found to also contain significantly elevated levels of antibodies to other respiratory viruses (p<.002) as compared to a random sampling of seven other standard IVIG products as determined by laboratory analysis.
The poster presentation can be viewed on ADMA Biologics' corporate website under: http://www.admabiologics.com/drug-development/posters-and-publications.
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 BioCenters a source plasma collection operation which provides ADMA with a portion of its blood plasma for the manufacture of RI-002 as well as generates revenues from the sale of source plasma to third parties. 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 (e.g., Streptococcus pneumoniae, H. influenza type B, Cytomegalovirus (CMV), measles, tetanus, etc.) as well as standardized, high levels of antibodies targeted to respiratory syncytial virus (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 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. All patients have completed dosing requirements in the Phase III trial and continue in follow-up. The primary endpoint data will be announced prior to December 31, 2014.
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), trends relating to demand for source plasma and our ability to sustain the listing of our common stock on the NASDAQ Capital Market. Forward-looking statements are subject to many risks and uncertainties that could cause our actual results and the timing of certain events 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, changes in supply and demand for source plasma, whether we will be able to sustain the listing of our common stock on the NASDAQ Capital 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 forward-looking statements.
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Source:ADMA Biologics, Inc.