Biotest announces clinical trial data for its new investigational Intravenous Immunoglobulin (IVIG) product for the US market
- Category: Antibodies
- Published on Friday, 13 April 2012 12:04
- Hits: 388
DREIEICH, Germany I April 11, 2012 I Biotest AG announces the publication of its US subsidiary Biotest Pharmaceuticals Corporation (BPC), Boca Raton, Florida, USA of Wasserman et al.,:
"Safety, Efficacy and Pharmacokinetics of a New 10% Liquid Intravenous Immunoglobulin (IVIG) in Patients with Primary Immunodeficiency." in the Journal of Clinical Immunology (Http://dx.doi.org/10.1007/s10875-012-9656-5). The published clinical data reports the efficacy of a Biotest new investigational IVIG product, a 10% liquid product, which does not contain any sugar.
The primary investigator, Dr. Richard Wasserman, summarized the results of the clinical trial: “Biotest’s investigational IVIG product offers a modern 10% liquid and sugar-free immunoglobulin that was well tolerated in the study patients. The product met the primary and secondary endpoints of the study. The PIDD (Primary immune deficiency disorder) community will welcome a new alternative product.”
Dr. Georg Floss, CEO of Biotest Pharmaceuticals Corporation, stated: “Biotest Pharmaceuticals has diligently worked to develop this new IVIG 10% liquid specifically for the US market. Biotest is confident that this product will provide patients a unique alternative from a new source with a long legacy of dependability and quality around the world. We look forward to providing this new product to the US Healthcare system from our facility in Boca Raton, Florida, USA.”
The study followed 63 patients with defined primary antibody deficiency for 12 months. All patients maintained an average serum IgG (immunoglobulin) level above 500 mg/dL.
The primary efficacy endpoint, the rate of acute serious bacterial infections (SBI) (0.035 SBI/patient-year), was well below the FDA target of ≤1.0 SBI/patient-year.
Among other efficacy parameters, the rate of days away from work or school due to infection was 2.28 days/patient-year. Additionally, 63.8% of patients in the trial did not miss a day of work or school.
Earlier this year Biotest’s investigational IVIG virus validation data was published in Results in Immunology: Dichtelmüller et al.:"Effective virus inactivation and removal by steps of Biotest Pharmaceuticals IGIV production process." (Immunology (Vol 2, 2012, pp 19-24)). The virus validation experiments concluded that the three virus inactivating and/or removal steps employed in Biotest’s manufacturing process are robust and effective.
Biotest is currently seeking marketing approval from the FDA for this investigational IVIG product based upon these and other clinical data. Biotest expects a decision regarding such approval sometime in the first half of 2012.