|Inovio Says DNA Vaccine Shows Potential To Treat Cervical Cancer|
|By Staff and Wire Reports|
|Monday, 13 September 2010 06:50|
Inovio Pharmaceuticals Inc (NYSE: INO) is reporting that it has achieved best-in-class immune responses in its Phase I dose escalation study of VGX-3100, the Company's DNA vaccine to treat pre-cancerous cervical dysplasias and cervical cancers caused by human papillomavirus (HPV) types 16 and 18.
The company said that this vaccine targets HPV E6 and E7 proteins and is delivered via in vivo electroporation.
"We have raised the bar in terms of T-cell immune responses achieved by any DNA vaccine platform in humans," said Dr. J. Joseph Kim, Inovio's President and CEO. "We are pleased that the results of this Phase I study strongly support advancing this vaccine candidate to Phase II clinical studies. An important goal for us was to also validate our DNA vaccine platform in the clinic to support the development of our other vaccine candidates: we have definitively accomplished this goal."
The study tested the safety and immunogenicity of VGX-3100 in women previously treated for moderate or severe cervical intraepithelial neoplasia (CIN 2/3), a high grade premalignant lesion that may lead to cervical cancer. The trial enrolled patients in three cohorts of six subjects each with DNA vaccine doses of 0.6 mg (0.3 mg each of two DNA plasmids), 2.0 mg, and 6.0 mg. Each subject received the respective dose at day 0, month 1 and month 3. All subjects in the first and second dose groups have completed the nine month follow-up period. Patients in the third dose group will complete their follow-up in the first quarter of 2011.
According to the company, all dose groups developed significant antibody and T-cell immune responses; however, more notably, in the third and final dose group, five of six (83%) patients developed unprecedented T-cell responses not achieved by any other non-replicating vaccine platform in humans.
The company said that it is planning to start a Phase II clinical study in the first quarter of 2011.