Profile: OncoGenex Pharmaceuticals Inc (OGXI.OQ)
23 Sep 2016
OncoGenex Pharmaceuticals, Inc., incorporated on March 22, 1995, is a clinical-stage biopharmaceutical company engaged in the development and commercialization of therapies that address treatment resistance in cancer patients. The Company's segment is dedicated to the development and commercialization of cancer therapies, with operations located in Canada and the United States. The Company's product candidates include Custirsen, Apatorsen and OGX-225. These products are designed to block the production of specific proteins that promotes treatment resistance and survival of tumor cells, and are over-produced in response to a variety of cancer treatments. The Company is focused on targeting these particular proteins to disable the tumor cell's adaptive defenses, thereby rendering the tumor cells susceptible to attack with a range of cancer therapies. Of these product candidates, Custirsen and Apatorsen are clinical-stage assets.
Custirsen is being evaluated in two Phase III trials; one in patients with prostate cancer and one in patients with non-small cell lung cancer (NSCLC). Custirsen is designed to inhibit the production of clusterin. The Company and collaborating investigators have conducted a Phase III clinical trial and over five Phase II clinical trials to evaluate the ability of Custirsen to enhance the effects of therapy in prostate, non-small cell lung and breast cancers. The SYNERGY Phase III trial was designed to evaluate a survival benefit for Custirsen, in combination with first-line docetaxel chemotherapy, in men with metastatic castrate-resistant prostate cancer (CRPC). The Company's AFFINITY trial is a Phase III clinical trial to evaluate a survival benefit for Custirsen. ENSPIRIT trial is a Phase III clinical trial to evaluate a survival benefit for Custirsen in combination with docetaxel treatment as second-line chemotherapy, in patients with NSCLC.
Apatorsen is a product candidate designed to inhibit production of heat shock protein 27 (Hsp27), a cell-survival protein expressed in various cancers, including bladder, non-small cell lung, pancreatic, prostate and breast cancers. Hsp27 expression is stress-induced by many anti-cancer therapies. The Company with collaborating investigators is conducting over two Phase I and approximately seven randomized Phase II clinical trials. The Company is conducting clinical trials to evaluate Apatorsen in several cancer indications and treatment combinations to accelerate the development of Apatorsen. It has completed Borealis-1 Phase II trial, which was a three-arm, randomized, placebo-controlled trial.
The Company's Apatorsen development activities for NSCLC include the Spruce trial and the Cedar trial. The Spruce trial is an investigator-sponsored, randomized, placebo-controlled Phase II trial evaluating Apatorsen plus carboplatin and pemetrexed therapy or placebo plus carboplatin and pemetrexed therapy in patients with previously untreated advanced non-squamous NSCLC. The Cedar trial is an investigator-sponsored, randomized Phase II trial evaluating Apatorsen plus gemcitabine and carboplatin therapy or gemcitabine and carboplatin therapy alone in patients with previously untreated advanced squamous NSCLC. The Apatorsen development activities of the Company for pancreatic cancer include the Rainier trial, an investigator-sponsored, randomized, placebo-controlled Phase II trial evaluating Apatorsen in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine in approximately 130 patients with previously untreated metastatic pancreatic cancer. The Apatorsen development activities of the Company for prostate cancer include the Pacific trial, an investigator-sponsored, randomized Phase II trial evaluating Apatorsen in men with CRPC, experiencing a rising prostate specific antigen (PSA), while receiving Zytiga (abiraterone acetate).
OGX-225 is a product candidate designed to inhibit the production of Insulin Growth Factor Binding Proteins-2 and -5 (IGFBP-2, IGFBP-5), two proteins that affect the growth of cancer cells when overexpressed. Preclinical studies with human prostate and breast cancer cells have shown that reducing IGFBP-2 and IGFBP-5 production with OGX-225 sensitized these tumor types to hormone ablation therapy or chemotherapy and induced tumor cell death. The Company has completed Investigational New Drug (IND) enabling toxicology studies for OGX-225.
OncoGenex Pharmaceuticals Inc
19820 N Creek Pkwy Ste 201
BOTHELL WA 98011-8227
Company Web Links
- OncoGenex seeks strategic alternatives after drug study fails
- UPDATE 1-OncoGenex seeks strategic alternatives after drug study fails
- BRIEF-Oncogenex's Phase 3 trial of Custirsen in men did not meet primary endpoint
- BRIEF-Oncogenex Pharma Q2 revenue $2.1 million vs est $1.2 million
- BRIEF-Oncogenex Pharmaceuticals qtrly loss per share $0.12