P53 Gene Therapy Shows Added Efficacy When Used in Combination

A shareholder brought to our attention a recent article (“Chemotherapy Plus p53 Gene Therapy May Help Treat Locally Advanced Cervical Cancer”) that we thought might be of interest to others. Results from a clinical trial, cited in the article, speak to the potential of Kevetrin—Innovation’s p53-modulating, anti-cancer drug candidate currently enrolling patients in a Phase 2a trial in late-stage, refractory, platinum-resistant Ovarian Cancer (OC).

In the trial, cervical cancer patients were divided evenly into two groups, 20 patients each: those receiving chemotherapy only (monotherapy); and those receiving chemotherapy plus p53 gene therapy delivered as 3 intratumoral injections at intervals of 3 days (combination therapy). Using samples taken from 18 control patients with cervical cancer who did not undergo chemotherapy, radiotherapy, or gene therapy, researchers then evaluated tumor size, side effects and the ability of p53 to decrease the expression of two genes associated with cancer growth, VEGF and MVD, respectively.

Efficacy results showed:

·        95% of patients in the Combined Group saw clinical benefits, including:

o       2 Complete Responses
o       17 Partial Responses
o       1 Stable Disease

·        75% of patients in the Chemotherapy-Only Group saw clinical benefits, including:

o       15 Partial Responses
o       5 Stable Disease

Tumor size was significantly decreased by more than 15cm2 in the Combined Group, compared to approximately 11.5cm2 in the Chemotherapy-Only Group.

The full article is linked to below.

Xiao, J., Zhou, J., Fu, M., Liang, L., Deng, Q., Liu, X., & Liu, F. (2017). “Efficacy of recombinant human adenovirus-p53 combined with chemotherapy for locally advanced cervical cancer: A clinical trial.” Oncology Letters, 13, 3676-3680.

Similar tumor biopsies, genetic pathway analyses and efficacy evaluations (per RECIST criteria) will be performed in the ongoing Phase 2a trial of Kevetrin in OC.

Kevetrin might also eventually be shown to be particularly beneficial when used in combination with chemoradiation therapies—sensitizing these treatment approaches, at the genetic level, so as to increase overall therapeutic effect.

Laboratory studies conducted by Innovation and at leading institutions on the effects of Kevetrin in combination with approved cancer drugs, including studies against renal cancer, pancreatic cancer, ovarian cancer, glioblastoma and acute myeloid leukemia, have delivered promising data supporting the ability of Kevetrin to enhance chemosensitivity.

Source: https://www.spandidos-publications.com/ol/13/5/3676