Shares of Inovio Pharmaceuticals ($INO) jumped about 20% this morning after the biotech said it hit the mark on the primary endpoint for its mid-stage study of VGX-3100, an experimental therapy designed to eliminate precancerous cervical lesions. But the company quickly found itself in the cross hairs of TheStreet's Adam Feuerstein, who has been trashing the company's efforts.
First, the data. In a per protocol analysis (we'll get back to that), Inovio says that the therapy--which spurs an HPV-specific T cell response--49.5% of women with CIN2/3 (cervical intraepithelial neoplasia) level cases had the disease either knocked back to CIN/1 or no sign of disease compared to 30.6% of the women in the placebo arm. That was statistically significant, says the biotech, the trial was a success and now Inovio will go into a late-stage study with a better understanding on trial design and execution.
Feuerstein--noted for his frequent jihads targeting small biotechs--quickly hooted on Twitter that the company's numbers were a "spin" job. In particular, he jabbed a finger at the per protocol analysis, which only tracks the results among subjects who completed the study "per protocol"--dropping patients who violated the protocol. That may be better at tracking biologic activity of a therapy, but intent-to-treat analysis is widely considered a better, more conservative way to track real-world results.
Feuerstein has already noted that by historical standards, the placebo arm should have seen about a 35% response rate.
Don't expect Plymouth Meeting, PA-based Inovio to roll over on this dog fight, though. After Feuerstein critiqued the Phase II study back in June, Inovio execs put out a release that scoffed about the "inane conjecture" that had caused a hubbub among its investors. Inovio has never been reluctant to toot its own horn, and execs adopted a sunny attitude in today's release.
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| Mark Bagarazzi |
"This is a significant step toward providing women and their physicians a non-surgical approach to the treatment of precancerous lesions by stimulating their immune system to eliminate high risk HPV infection and induce regression of a cervical intraepithelial neoplastic process," said Mark Bagarazzi, Inovio's chief medical officer, in a statement. "This proof of concept trial will guide the advancement of VGX-3100 for precancerous dysplasias as well as HPV-associated cervical, head and neck, and anogenital cancers."
- here's the release