PDS Biotechnology Corp., a clinical-stage biotechnology company focused on the development of novel immunotherapy treatments for cancer and other chronic diseases, as well as novel preventive vaccines, today announced that the first patient has been successfully vaccinated with PDS0101 in a Phase 1 clinical trial in patients with cervical intraepithelial neoplasia.
The trial which is being conducted at three leading gynecological oncology centers in the United States is designed to evaluate the safety, feasibility and immunological responses of the novel Versamune™-based PDS0101 cancer immunotherapy in patients with cervical intraepithelial neoplasia.
"The ability to effectively train and prime our body's immune system to specifically target and kill cancer cells has recently shown significant promise in treating various cancers," said Dr. Frank Bedu-Addo, CEO of PDS Biotechnology. "Should the unique safety profile and efficacy of Versamune™ and PDS0101 demonstrated in preclinical studies be successfully replicated in humans, this will represent a significant advancement in the treatment of cancer. It would also represent a significant advancement in the treatment of early-stage cancer and certain infectious diseases where there is a high and growing unmet medical need not addressed by current approaches."
About PDS Biotechnology Corporation
PDS Biotechnology is a private biotechnology company applying its ground-breaking Versamune™ nanotechnology platform vector to the development of simpler, safer and more effective cancer immunotherapies and preventive vaccines. PDS0101 is the company's lead cancer immunotherapy in development to treat HPV-induced cancers. The company has a second cancer immunotherapy and pandemic influenza vaccine in the early stages of development. In 2012 PDS Biotechnology granted Merck KGaA a license to utilize the Versamune™ vector in two specific cancer immunotherapies. For more information on PDS biotechnology please visit www.pdsbiotech.com.
About Versamune™ and PDS0101
PDS0101 is a cancer immunotherapy based on PDS Biotechnology's patented Versamune™ nanotechnology vector, and contains multiple unique sequences from a cancer causing strain of the human papillomavirus that have been modified to be more immunogenic.
Versamune™ is based on certain structurally-specific lipids which possess unique immune modulating characteristics. In preclinical studies Versamune™ was demonstrated to facilitate uptake and processing of the cancer proteins by the immune system. It also enhanced successful priming and training of cancer-killing T-cells, and simultaneously reduced the population of immune suppressive cells leading to superior efficacy in eradicating the cancer in preclinical studies. For more information on Versamune™ and how it works please visit www.pdsbiotech.com.
Cancers Caused by the Human papillomavirus
Patients diagnosed with the various HPV-induced cancers such as today have very limited treatment options, predominantly surgery, chemotherapy and radiation therapy.
Cervical intraepithelial neoplasia (CIN) is the abnormal growth of cells on the cervix. A small percentage of CIN cases progress to become cervical cancer if left untreated. The annual worldwide incidence is about 1.4 million. The current treatment for high grade CIN involves removal of the cervical cells by methods such as loop electrical excision procedure (LEEP). The recurrence rate is reportedly about 20%, and surgical treatment is associated with an increased risk of infertility.
Oropharyngeal squamous cell carcinoma (OSCC): Over 70% of OSCC are estimated to be HPV-associated in Western countries. It is predicted that the incidences of HPV-positive oral cancers will exceed the annual number of cervical cancer cases by 2020.
Cervical Cancer: It was estimated that in the US there would be over 12,000 newly diagnosed cases of cervical cancer in 2013.