Clinical Trials

Date: 2017-01-06

Type of information: Interim results

phase: 2

Announcement: interim results

Company: Genprex (USA - TX

Product: Oncoprex™ and erlotinib

Action mechanism:

• gene therapy/immunotherapy product/epidermal growth factor receptor tyrosine kinase inhibitor/EGFR tyrosine kinase inhibitor (EGFR.
• Research has shown that over 80% of cancer cells of many types of cancer, including NSCLC, lack a tumor suppressor gene called TUSC2 (formerly known as FUS1), a kinase inhibitor which has been shown in-vivo to affect cell proliferation and programmed cell death. Oncoprex is an optimized TUSC2 gene encapsulated in a fatty, positively charged nanovesicle (a nanoscale hollow sphere) injected intravenously, which can specifically target cancer cells and insert wild-type TUSC2 into cellular DNA, effectively taking the place of the defective TUSC2 gene and inducing cell death.
• Oncoprex combines features of gene therapy and immunotherapy in that it up-regulates the tumor suppressor gene TUSC2 (formerly FUS1), increases the anti-tumor immune cell population, and down-regulates PD1 and PD-L1 receptors thereby boosting the immune response to cancer.
• Pre-clinical data also indicate that Oncoprex can be combined with several other approved cancer therapies to improve efficacy with minimal side effects and become a complementary therapy for other cancer treatments.
• Erlotinib (Tarceva®) is an EGFR tyrosine kinase inhibitor.

Disease: late non-small cell lung cancer (NSCLC)

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

• The goal of phase 1 of this clinical research study is to find the highest dose of DOTAP:Chol-fus1 that can be safely given in combination with Tarceva (erlotinib hydrochloride) to patients with NSCLC.
• The goal of phase 2 of this clinical research study is to learn if the combination of DOTAP:Chol-fus1 and erlotinib hydrochloride can help to control NSCLC.
• The safety of this drug combination will also be studied in both phases. (NCT01455389 

Latest news:

• • On January 6, 2017, Genprex announced positive interim data from an ongoing Phase II clinical trial evaluating its investigational immunogene therapy candidate Oncoprex™ in combination with the tyrosine kinase inhibitor (TKI) erlotinib (Tarceva®) for the treatment of late stage non-small cell lung cancer (NSCLC) patients.
• The clinical trial, which is ongoing at The University of Texas MD Anderson Cancer Center, is designed to evaluate the Oncoprex/erlotinib treatment combination in up to 57 patients with late stage NSCLC, with and without EGFR mutations, who have failed at least two drug regimens.
• The clinical trial results in nine patients evaluable to date show an overall disease control rate (stable disease, partial response or complete response) of 78%.
• One EGFR negative patient with multiple targeted lesions experienced a durable complete response.
• One EGFR negative patient experienced regression of targeted lesions by 24%.
• One EGFR negative patient experienced regression of 30% in one targeted lesion, and regression of 18% over all targeted lesions.
• One patient who was EGFR positive, but without the T790M mutation, achieved stable disease, tumor regression, and decreased metabolic activity by PET scan in multiple tumors.
• Three  additional patients achieved stable disease characterized by lack of disease progression after at least two treatments, each 21 days apart.
• The EGFR negative patients’ disease had progressed following chemotherapy or immunotherapy.
• The EGFR positive patient’s disease had progressed following treatment with Tarceva. The data from the patients treated at the time of analysis show a favorable safety profile similar to what was observed in two previous Phase I clinical trials.
• “These interim data suggest that this targeted therapy may provide a viable treatment option for late stage NSCLC patients, with or without EGFR mutations, whose disease has progressed following currently available treatments,” said Rodney Varner, CEO of Genprex. “If these positive interim results are sustained in either of these populations through the trial’s conclusion, we plan to ask the FDA to grant accelerated approval for this therapy.
• • On May 20, 2014, Genprex announced that it has enrolled the first patient in a clinical trial evaluating its lead product candidate Oncoprex® in combination with erlotinib (Tarceva®) for late-stage lung cancer patients. The trial is significant in that it seeks to determine if patients without the EGFR activating mutation as well as patients with the EGFR activating mutation whose cancer has progressed after erlotinib treatment can benefit from the Oncoprex + erlotinib combination therapy.

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Is general: Yes