Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

Do NOT expect a miracle cure from Kevetrin as a single agent!!!

The FACTS about Kevetrin

Oncology Studies

We are now in the ninth cohort of a Phase 1 trial of Kevetrin for advanced solid tumors that is being hosted at Harvard University’s Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center. To briefly recap, Kevetrin is a novel compound that acts upon the protein p53, a protein with such an important role in controlling cell cycles that it has been dubbed the “guardian angel gene.” The primary endpoint of the trial is to determine the safety of Kevetrin, but we are also establishing the maximum tolerated dose (MTD) and evaluating Kevetrin’s influence on key biomarkers, as well as looking for signs of effect on tumor size.

Previously in the eighth cohort, patients were treated with 215 mg/m2 of Kevetrin with no drug-related adverse events reported. The present dose for the ninth cohort is 350 mg/m2. We believe that this increased dosage is putting Kevetrin very close to its MTD. Through the first eight cohorts, the preliminary data has been very encouraging, including one ovarian stromal carcinoma patient completing 7 dosing cycles. CA-125, an ovarian cancer marker, was also stabilized in some patients. The biomarker p21 increased in 6 of 14 patients at relatively low doses of Kevetrin and we expect a higher percentage of p21 expression when the data is evaluated from higher doses. Another tumor marker, CEA, was decreased and the tumor size remained stable over 4 months in a pancreatic carcinoma patient.

The trial reaching its late stages and the data that has been collected to date has cleared the path for a new Phase 1b/2 trial of Kevetrin in combination with cytarabine for Acute Myelogenous Leukemia. The protocol has been submitted to the ethics committee and the trial is expected to commence in the fourth quarter 2014. This trial is being sponsored by the University of Bologna in Italy and its partners and hosted at European clinical sites. Our commitment is only to supply the Kevetrin for the study. The protocol for this trial schedules patients to be treated with shorter intervals between doses than the current ongoing trial in the U.S., which will provide vital information going forward with the development of Kevetrin.

Our oncology initiatives are also focused on oral mucositis, a common and often debilitating condition affecting the mouth and pharynx as a side effect of certain cancer treatments, including chemotherapy and radiation therapy given to approximately 500,000 people each year who have head and neck cancer.

http://cellceutix.com/best-yet-to-come/#sthash.xlJzPpQO.dpbs

Good luck and GOD bless,

George