BLUE BELL, Pa., Mar. 7, 2011 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it is initiating a Phase II clinical trial for its VGX-3100 DNA vaccine for cervical dysplasia and cancer caused by human papillomavirus (HPV).
The study will assess adult females with CIN 2/3 or CIN 3 and biopsy-proven HPV 16 or 18. Cervical intraepithelial neoplasias (CIN) are pre-cancerous stages of abnormal cells that precede cervical cancer. HPV types 16 and 18 are responsible for 70% of CIN 2/3 and cervical cancer incidences. The randomized, placebo-controlled, double-blind study will evaluate cervical tissue changes after three 6 mg doses of VGX-3100 are administered by injection in combination with Inovio's CELLECTRA® electroporation delivery device. A total of 148 patients will be enrolled in 25 study centers in the US, Korea, South Africa, Australia, and Canada.
The primary endpoints of this study are to assess regression of cervical lesions to CIN 1 or less and clearance of HPV 16 or 18. The study will evaluate the efficacy of the vaccine in patients who receive VGX-3100 at 0, 4 and 12 weeks compared to placebo recipients, based on a biopsy performed six months after the final vaccine dose.
The study will also explore humoral and cell mediated immune responses to VGX-3100 in blood samples taken prior to the first vaccine dose and periodically thereafter. Cervical samples will be analyzed for evidence of immune responses in the cervix at the beginning of the trial and subsequent intervals. Subjects will also be monitored for tolerability and safety. The clinical trial protocol, HPV-003, is available at: http://clinicaltrials.gov/ct2/show/NCT01304524?term=NCT01304524&rank=1.
This Phase II trial is a follow-on to Inovio's Phase I dose escalation study of VGX-3100, which achieved best-in-class immune responses. In that study, 13 out of 18 vaccinated subjects (72%) developed significant T-cell responses, with positive responses ranging from under 100 to over 5000 SFU per million cells. In the third and highest dose group, 83% (5 of 6) had strong T-cell responses. In addition, 15 of 18 vaccinated subjects (83%) developed antibody responses to at least one antigen with most subjects developing responses to two or more antigens. No DNA vaccine has previously achieved this rate of response.
Dr. J. Joseph Kim, Inovio's president and CEO, said: "The initiation of this cancer vaccine trial is a milestone for Inovio. This is the first Phase II trial with an internally developed SynCon™ DNA vaccine, indicating the growing maturity of our product pipeline. We are encouraged by the precedent set in achieving demonstrable clinical efficacy by other vaccines in clinical development using different vaccine platforms targeting these antigens. VGX-3100 vaccine has demonstrated best-in-class immune responses and we look forward to the potential translation of those results into improved clinical efficacy."
About Cervical Dysplasias/Cancers and Inovio's Therapeutic DNA Vaccine
Human papillomavirus (HPV) is the causative agent responsible for most cases of cervical cancer. At any given time, approximately 10% of women worldwide are infected with HPV. While roughly 70% of HPV infections are cleared by the body on its own, persistent HPV can lead to dysplasia, or premalignant changes in cells, of the cervix. Researchers have estimated the global prevalence of clinically pre-cancerous HPV infections at between 28 and 40 million. Persistent dysplasias may then progress to cancer. Every year, 510,000 cases of cervical cancer are diagnosed worldwide, and about 288,000 of the afflicted women, primarily in developing countries, die.
Preventive vaccines such as GARDASIL® and CERVARIX® are playing an important role in limiting new HPV infections. However, preventive vaccines cannot provide protection for those already infected, which is a large population. In addition, a significant number of the girls and women eligible to be vaccinated are not receiving these preventive vaccines. There is no viable therapeutic vaccine or drug to fight HPV, nor dysplasias and cancers caused by HPV. Current ablative or surgical procedures to remove cervical dysplasias and cancers are unappealing due to their potential for disfigurement, the perceived negative impacts on childbirth, and the stress of the watch-and-wait approach that typically precedes these procedures.
HPV types 6, 11, 16 and 18 are responsible for 35 – 50% of the 1.4 million low-grade CIN 1 dysplasias diagnosed annually in the US, while types 16 and 18 are responsible for about 70% of the 300,000 high grade CIN 2/3 dysplasias and cervical cancer incidences. Inovio's VGX-3100 is designed to raise immune responses against the E6 and E7 oncogenes common to HPV types 16 and 18. These oncogenes are responsible for transforming HPV-infected cells into pre-cancerous and cancerous cells. The goal is to stimulate a T-cell immune response strong enough to cause the rejection of these infected or transformed cells from the body. The potential of such a therapeutic vaccine would be to treat pre-cancerous dysplasias (CINs), cervical cancers, as well as other anogenital and head and neck cancers caused by these HPV types.
About Inovio Pharmaceuticals, Inc.
Inovio is developing a new generation of vaccines, called DNA vaccines, to treat and prevent cancers and infectious diseases. These SynCon™ vaccines are designed to provide broad cross-strain protection against known as well as newly emergent strains of pathogens such as influenza. These vaccines, in combination with Inovio's proprietary electroporation delivery devices, have been shown to be safe and generate significant immune responses. Inovio's clinical programs include cervical dysplasia and cancer (therapeutic), avian flu (preventive), and HIV vaccines (both preventive and therapeutic). Inovio is developing universal influenza and other vaccines in collaboration with scientists from the University of Pennsylvania. Other partners and collaborators include Merck, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
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This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, our ability to successfully integrate Inovio and VGX Pharmaceuticals, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2009, our Form 10-Q for the nine months ended September 30, 2010, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.
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