PDS Biotechnology's Versamune-based immunotherapy drug demonstrates safety in preclinical studies

Oct 6 2009

PDS Biotechnology Corporation today announced that the company has completed GLP toxicology studies of its lead HPV-cancer product. The studies, which included pharmacokinetic (PK) and adsorption, bio-distribution and excretion (ADE) studies in addition to the evaluation of toxicity, all demonstrated a very safe profile of the drug and PDS Biotech's platform Versamune((TM)) technology. No signs of toxicity were observed at the highest doses evaluated, significantly higher than the effective doses observed in preclinical studies. The studies also provided further confirmation of the technology's mechanism of action and efficient uptake by the immune system.

Dr. Frank Bedu-Addo, PDS Biotechnology's President and CEO, stated that this was a pivotal study in the company's progress towards confirming the technology's safety profile and evaluation in human clinical trials next year to treat cervical cancer. He also stated that "the high safety and efficacy that the technology has demonstrated will also enable the company to initiate discussions with prospective corporate partners to start developing the company's infectious disease drugs which will target widespread diseases such as hepatitis, HIV, influenza and herpes."

PDS0101 is a Versamune((TM))-based immunotherapy drug which has demonstrated significant promise in curing HPV infection and HPV-related cancer in preclinical animal and human model studies. Cancers caused by infection with the human papilloma virus (HPV) include cervical, head and neck and anal cancers. No cures exist for these cancers. The drug is administered by subcutaneous injection.

PDS Biotechnology Corporation's Versamune((TM)) nanotechnology facilitates efficient uptake of disease-associated proteins and peptides by cells of the immune system and simultaneously acts as a strong immune system activator (adjuvant) without the inflammatory side effects induced by current adjuvants. The result is simple, safe and cost effective nanotechnology-based drugs and vaccines that induce effective eradication of the specific cells infected with, or expressing the particular protein formulated with Versamune((TM)). PDS0102 has demonstrated high preclinical efficacy in curing melanoma, the most aggressive form of skin cancer. The technology is based on Merck AG's proprietary enantiomer exclusively licensed to PDS Biotechnology for use in Versamune((TM)).