Innovation Pharmaceuticals Inc (IPIX)

[TheDane]

Here's something...not sure what it is but noticed it looked like a job "situation" at first. See bold.

http://www.avarx.com/AvaRx/SubDomains/bucket5599045764071943220/Listings/bucket1105698590816635493/Public.Listing.display.html
Kevetrin
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Therapeutic Area
Oncology - Solid Tumors , Oncology - Liquid Tumors

Development Phase
Phase I

Indication
Cancer (General) , Leukemia- Acute Myeloid (AML) , Ovarian Cancer , Kidney Cancer / Renal Cell Carcinoma

Situation
Licensing Opportunity , Oncology - Cell Cycle Arrest / Apoptotics

Rights Available
Worldwide

Rt. of Administration
Intravenous

Molecule Type
Small Molecule

AvaRx Number
Last Updated On
AV-2696
Jan 21, 2015
Description
Kevetrin is a p53 activator in Phase 1 clinical development for solid tumors as well as acute myeloid leukemia.

Situation Overview
Kevetrin is a small molecule compound with a structure that is distinct from other anti-cancer agents currently on the market. One of the main causes of failure in the treatment of cancer is the development of drug resistance by the cancer cells. Kevetrin has been studied extensively (in vitro and in vivo) demonstrating potent anti-cancer activity against various cancer cell lines. It has consistently shown activity as good as or better than standard chemotherapeutic therapies, given at approximately equitoxic doses. Kevetrin has demonstrated potent anti-tumor efficacy against various carcinoma xenograft models: lung, breast, colon, prostate and squamous cell carcinoma, and in a leukemia tumor model. In drug-resistant cell lines, Kevetrin has shown excellent activity, galvanizing the Company to focus on Kevetrin's development potential in this area.

Mechanism of Action
Kevetrin?s primary mechanism of action has been shown to induce activation of p53, often referred to as the ?Guardian Angel Gene? due to its crucial role in controlling cell mutations. p53 is a tumor suppressor protein that is encoded by the TP53 gene in humans and has been widely regarded as possibly holding a key to the future of cancer therapies. p53 has been shown to play critical roles in the homeostatic health of the human body by activating proteins required to repair DNA and plays a major role in the life cycle of cells by inducing cell cycle arrest and apoptosis to maintain cellular and genetic stability.

Clinical Trials
Cellceutix is currently conducting a Phase 1 clinical trial at Harvard Cancer Center???s Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center. The open-label, dose-escalation clinical trial is evaluating Kevetrin, administered intravenously in patients with advanced solid tumors. The objective of the trial is to determine PK/PD, tolerance, safety, and maximum tolerated dose (MTD) in patients with the diagnosis of refractory solid tumors. The study is designed to enroll approximately 40 patients in the dose-escalation portion of study. Once the MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level to further evaluate this dosage safety and pharmacodynamics. The primary objectives of the study are to determine the MTD and dose limited toxicity (DLT) of Kevetrin and to establish a safe dose level of Kevetrin that can be used for future studies.

The University of Bologna in Italy plans on testing Kevetrin for efficacy against Acute Myelogenous Leukemia (AML). The planned Phase 1B is a multi-center, open-label, dose optimization trial with Kevetrin, administered intravenously with Cytarabine administered either subcutaneously or intravenously. The University of Bologna will source the funding for this trial and plans to initiate the trial once a higher MTD is achieved in the Phase 1 trial conducted at Dana-Farber.

In January 2015, Cellceutix reported the near complete disappearance of a metastatic lesion in the spleen of a Stage 4 ovarian cancer patient who was enrolled in the Company's Phase 1 clinical trial of anti-cancer drug candidate Kevetrin? being conducted at Harvard Cancer Center's Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. With the completion of the ninth cohort, and commencement of tenth cohort at 450 mg/m2, the hospital has continued research to determine the effect of Kevetrin on p21. Research conducted by the hospital evaluating p21 expression in earlier cohorts, for which the level of exposure to Kevetrin was substantially lower, showed that about 50 percent of the patients demonstrated at least a 10% increase in p21. The data supported the hypothesis that enhanced p21 is dose related, meaning that as the amount of Kevetrin increased, so did the p21 expression. Hospital scientists are now running samples examining the effect of Kevetrin on p21 at higher dosing levels in more recent cohorts and Cellceutix hopes to disclose the results shortly.

Partners by Region
This product is currently unpartnered.