PORT HUENEME, CA -- (Marketwire) -- 03/13/13 -- Stellar Biotechnologies, Inc. ("Stellar" or "the Company") (OTCQB: SBOTF) (TSX VENTURE: KLH) today announced the presentation of results from a preclinical study of Keyhole Limpet Hemocyanin (KLH), conducted together with a partner, showing that manufacturing source and molecule form can impact the magnitude and consistency of antibody response to KLH.
The abstract titled "T-Cell Dependent Antibody Responses in the Rat: Forms and Sources of KLH Matter" (http://www.klhsite.com/storage/PS%202062%20J%20Society%20of%20Tox%20132.1.pdf) will be presented this week in a Poster session at the 52nd Annual Meeting of the Society of Toxicology (SOT) (March 10-14, 2013) at the Henry B. Gonzalez Convention Center in San Antonio, Texas.
KLH is used extensively in drug immunotoxicology to measure the T-cell dependent antibody response (TDAR). TDAR testing is widely recognized by regulatory agencies and drug developers worldwide as a standard method of assessing the suppressive effects of immunomodulating drugs on the immune system.
In the study, anti-KLH IgM and IgG responses were measured in rats immunized with five different KLHs from three KLH commercial sources, including Stellar KLH. All test articles were administered without co-injection of an adjuvant. Dose analysis and biophysical characterization were also conducted. Among GMP grade KLHs tested in the study, Stellar HMW KLH and Stellar Subunit KLH elicited the greatest IgM and IgG responses. In addition, Stellar Subunit KLH elicited the greatest IgM and IgG responses compared to the subunit KLHs from other sources.
"Stellar has long understood the impact that source and manufacturing process can have on the KLH molecule," said Herb Chow, Ph.D., Stellar Chief Technical Officer. "This data confirms our internal studies and our belief that Stellar's cGMP manufacturing processes deliver a more stable KLH with superior immunogenicity."
The rapidly growing number of immunomodulating agents in drug company pipelines is driving the need for improved methods to assess the effect of these new drugs in patients. Stellar's goal is to improve the predictive value of immunotoxicology studies by delivering KLH products that can transition from pre-clinical to clinical phases, and help deliver meaningful information about immune response. Clients using KLH for TDAR testing include the many clinical research organizations ("CROs") and pharmaceutical developers needing KLH in all phases of drug development.
Abstract/Poster: Abstract # 2062 / Poster Board # 119 (http://www.klhsite.com/storage/PS%202062%20J%20Society%20of%20Tox%20132.1.pdf)
Session Title: Immunotoxicity Methods
Presentation Date & Time: March 13, 2013 from 1:00 PM to 4:30 PM
Abstract published online in The Toxicologist http://www.toxicology.org/AI/PUB/Tox/2013Tox.pdf) March 2013, ISSN 1096-6080, Vol 132(1):440
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