PDS Biotechnology Corporation today announced that the company has been awarded a $1.28M phase 2 SBIR contract by the National Cancer Institute division of the US National Institutes of Health. The contract provides funding to complete studies required to file an Investigational New Drug Application (IND) with the FDA for the company's lead human papillomavirus (HPV)-cancer product late in 2010. This curative vaccine, which is based on PDS Biotechnology's Versamune(TM) platform nanotechnology, has demonstrated potent efficacy in curing HPV infection and HPV-related cancer in preclinical animal and human model studies. Over 400 million people are infected with the HPV virus and several common cancers are caused by the infection, including cervical, head and neck and anal cancers.
No cures exist for these cancers.
The award was based on successful completion of a phase 1 SBIR contract demonstrating efficacy of the drug in human model systems, as well as recent GLP toxicology, pharmacokinetic and bio-distribution studies demonstrating an excellent safety profile and efficient uptake of the drug by the immune system. The new contract will cover over 70% of the costs required to complete the IND-enabling studies. The remaining 30% of the costs will be covered by non-federal government funds.
PDS Biotechnology's Versamune(TM) nanotechnology platform facilitates efficient uptake of disease-associated proteins and peptides by cells of the immune system and simultaneously acts a strong immune system modulator without the inflammatory side effects induced by current immune stimulators (also known as adjuvants). The result is simple, safe and cost effective drugs and vaccines that induce effective eradication of the specific cells infected with, or expressing the particular disease-related protein formulated with Versamune(TM). The company's Versamune(TM)-based melanoma product has also demonstrated high efficacy in curing melanoma, which is the most aggressive form of skin cancer, in preclinical animal studies.