Updated from 10:17 am EDT with new information.
Inovio Pharmaceuticals (INO) declared a spin-laden victory Wednesday from its phase II study of the DNA vaccine VGX-3100 in women with high-grade cervical intraepithelial neoplasia (CIN 2/3), also known as cervical pre-cancerous lesions.
Surprised? Not really. I believe Inovio's goal from the outset was to find any nugget of positive data from the VGX-3100 phase II study -- even if the study actually failed -- in order to rationalize a move to a phase III study. The press release issued by Inovio Wednesday appears to have accomplished this goal.
On a per protocol basis, Inovio says the response rate to VGX-3100 was 49.5% compared to 30.6% for placebo -- a statistically significant difference. Response rate in this study was defined as regression of pre-cancerous cervical lesions from grade 2/3 to grade 1 or no disease.
But Inovio's per-protocol analysis of the study's primary endpoint omits patients. How many patient are missing from the analysis? We don't know because Inovio didn't disclose. The study was designed to enroll 148 patients, according to a design schema on ClinicalTrials.gov, but Inovio could have enrolled more. If 148 patients were enrolled, Inovio's per protocol analysis omits five patients -- four treated with VGX-3100 and one patient on placebo.
Inovio did not disclose the more important intent-to-treat analysis of the study's primary endpoint.
Shares of Inovio are up 17% to $13.03 in Wednesday trading. Spin works, at least for a little while.
Update: Inovio filed an 8-K with the Securities and Exchange Commission following this morning's press release stating an intent-to-treat analysis of the VGX-3100 study was also statistically significant. The company did not provide any specific information about the response rates, number of patients or p value from the intent-to-treat analysis.