Drug Enhances H1N1 Vaccine Response

SciClone Pharmaceuticals, Inc. (Foster City, CA) and its partner Sigma-Tau, S.p.A. (Rome, Italy) have received initial topline results in a clinical study evaluating the potential of Zadaxin (thymalfasin) to enhance immune response to the MF59 adjuvanted H1N1 influenza monovalent vaccine, Focetria, from Novartis (Basel, Switzerland).

Zadaxin, scientifically referred to as thymalfasin or thymosin alpha 1, is SciClone's synthetic preparation of thymalfasin, a peptide produced by the thymus gland that circulates in the blood naturally. Published scientific and clinical studies have shown that thymalfasin helps stimulate and direct the body's immune system to improve response to vaccines, and to eradicate infectious diseases like HCV and HBV, as well as certain cancers.

In the immune system, thymalfasin stimulates stem cell differentiation and increases production of antibodies and disease-fighting T cells, including CD4, CD8, and natural killer cells, while simultaneously slowing the breakdown and removal of these T cells. The increase in production of antibodies after thymalfasin treatment leads to an increase in response to vaccines, providing enhanced protection against infection; the increases in T-helper cells allows the immune system to tag and identify invasive agents and cancerous cells for removal.

According to investigators, Zadaxin treatment given with the H1N1 vaccine led to a highly statistically significant (p value