OncoGenex Pharmaceuticals, Inc. engages in the development and commercialization of new therapies that address treatment resistance in cancer patients. The company has three product candidates in its pipeline: custirsen, apatorsen and OGX-225, each of which has a distinct mechanism of action and represents an opportunity for cancer drug development. Of the product candidates in the company’s pipeline, custirsen and apatorsen are clinical-stage assets being evaluated in two phase 3 studies and five phase 2 studies. Custirsen Custirsen is being evaluated in two phase 3 trials; one in patients with prostate cancer and one in patients with non-small cell lung cancer. The company and collaborating investigators have conducted one phase 3 clinical trial and five phase 2 clinical trials to evaluate the ability of custirsen to enhance the effects of therapy in prostate, non-small cell lung and breast cancers. The completed SYNERGY phase 3 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, or metastatic. Apatorsen Apatorsen is the company’s product candidate designed to inhibit production of heat shock protein 27 (Hsp27), a cell-survival protein expressed in many types of cancers including bladder, non-small cell lung, pancreatic, prostate and breast cancers. Hsp27 expression is stress-induced by many anti-cancer therapies. In 2013, the company initiated the ORCA (On-going Studies Evaluating Treatment Resistance in CAncer) program, which encompasses clinical trials designed to evaluate whether inhibition of Hsp27 can lead to improved prognosis and treatment outcomes for cancer patients. The company is conducting parallel clinical trials to evaluate apatorsen in various cancer indications and treatment combinations to accelerate the development of apatorsen. OGX-225 OGX-225 is the company’s 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. Strategy The key elements of the company’s strategy include gaining market approval for custirsen by conducting registration trials that demonstrate efficacy and safety, in both prostate and lung cancer; advancing apatorsen by conducting clinical trials across multiple cancer indications for apatorsen, including bladder, lung, pancreatic and prostate cancers; developing and commercializing new cancer therapies, including OGX-225, to inhibit treatment resistance in cancer patients; and optimizing the development of its product candidates through use of outsourcing and internal expertise. Agreements The company has an agreement with Isis Pharmaceuticals, Inc. (Isis) to jointly develop and commercialize custirsen. This strategic relationship provided the company with access to Isis’ proprietary position in second-generation antisense chemistry for use in custirsen, and Isis’ expertise in developing antisense therapeutics, including its manufacturing expertise, and allowed the company to develop custirsen. The company has a collaboration and license agreement with Isis to jointly identify antisense compounds designed to inhibit the production of proteins encoded by specified gene targets. OncoGenex Technologies is responsible for all product development activities for antisense compounds under this collaboration. This relationship provides OncoGenex Technologies with access to Isis’ proprietary position in second generation antisense chemistry for use in specified products. Research and Development Expenditures For the year ended December 31, 2014, the company’s expenditures for research and development activities were $46.2 million. Trademarks The company owns various trademarks registered in the United States, namely ONCOGENEX, ORCA, Spruce, and Rainier, and design marks ORCA, Cedar, Pacific, Borealis-1, Borealis-2, and the helical totem element that accompanies the clinical trial trademarked identifiers. In Canada, it has corresponding trademark registrations for all but RAINIER, which is pending, and the Cedar design. The company received notice from Cedars-Sinai that it has petitioned to cancel its trademark for the Cedar design in the United States, and may oppose the trademark in Canada. The company is in contact with Cedars-Sinai through its attorneys to arrange an amicable solution.
oncogenex pharmaceutical inc
19820 North Creek Parkway
Bothell, WA 98021
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