Innovation Pharmaceuticals Inc (IPIX)

[PlentyParanoid]

Predictable and anticipated result for Kevetrin trial.
Quote from filing at clinicaltrials.gov

Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 Weeks ]
Reporting of Adverse Events, and severity of adverse events

Evaluate changes in biomarkers between pre-treatment sample and post-treatment sample [ Time Frame: 3 Weeks ]
Changes in RNA and/or protein level of pre-specified biomarkers associated with the p53 signalling pathway and apoptosis will be compared between pre-treatment sample (tumor biopsy, ascites fluid, and peripheral blood) and post-treatment sample (tumor biopsy, ascites fluid, and peripheral blood)

Somewhat stunning quote from the same clinicaltrials.gov filing:

This is an open label, dose-escalation trial to study the safety, biomarker changes (including modulation of p53), objective tumor response changes, and pharmacokinetics following administration of two different treatment regimens of Kevetrin over a 3-week period to subjects with platinum-resistant/refractory ovarian cancer. Following the 3 weeks of Kevetrin dosing, subjects are to be followed up for 3 weeks after completion of Kevetrin treatment. Standard of care treatment, as medically appropriate and per local guidelines, outside of this study protocol can commence after the collection of the post-Kevetrin treatment biomarker samples (collected on Day 21±1 day).

Bertolino Quote:

“What we and potential partners are extremely interested in is learning via tumor biopsies if Kevetrin is reaching its target and modulating pathways within the tumor that can deliver a clinically meaningful benefit; this would be a significant development in the p53/oncology dynamic,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “If that is indeed the case in any number of patients, we will have compelling evidence to move forward expeditiously. A next step would be to complete development of an oral formulation of Kevetrin, which is the preferred delivery method of patients and facilitates the potential for multiple daily doses.

Quote from 10Q:

Highly encouraging preliminary positive data from the first patients treated showed direct evidence of molecular pathways modulation in tumors. Modulation of the p53 protein was observed in response to administration of Kevetrin; pathways analyses also pointed to concomitant cell cycle modulation at the level of gene expression. The Company believes that further pathways detail and clinical tumor responses would best be observable with more frequent and potentially higher drug exposure. Thus, the Company has decided to discontinue further enrollment into the current clinical trial and consider a similar trial when ongoing efforts result in the development of an oral formulation of Kevetrin for treating cancer.

Looks like IPIX got what they were looking for. Granted, not exactly as planned, but still. My guess is that a trial design flaw (the trial was designed to interfere with ongoing salvage treatment) put a heavy damper on enrollment enthusiasm. IPIX had their indication and decided: "This will do!" So, I am not upset with 10Q content. IPIX's press release has the essence correct, if sprinkled heavily with rosewater.

What intrigues me is this quote from 10Q:

The Company previously engaged KARD to conduct specified pre-clinical studies. The Company did not have an exclusive arrangement with KARD. All work performed by KARD needed prior approval by the executive officers of the Company, and the Company retained all intellectual property resulting from the services by KARD. The Company now has its own research study capabilities and no longer uses KARD.

If they are doomed and winding down, why are they bothering with their own research study capabilities? To me it looks like they are trying to transition into actual clinical stage company.