PDS Completes GLP Toxicology Studies Of HPV Cancer Product

PDS Biotechnology has completed GLP toxicology studies of its 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 safe profile of the drug and PDS Biotech’s platform Versamune technology.

The company said that no signs of toxicity were observed at the highest doses evaluated. The studies also provided further confirmation of the technology’s mechanism of action and efficient uptake by the immune system.

PDS0101 is a Versamune-based immunotherapy drug which demonstrates 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.

The company said that the versamune 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.

Frank Bedu-Addo, president and CEO of PDS, said: “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. 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.”