Healthcare Industry News: Isis Pharmaceuticals
News Release - May 3, 2006
OncoGenex Announces Encouraging Data from a Phase I Study of Patients with Non-Small Cell Lung CancerVANCOUVER, May 3 (HSMN NewsFeed) - OncoGenex Technologies Inc. today announced encouraging results from a Phase I study evaluating systemic administration of OGX-011 in combination with standard chemotherapy agents, gemcitabine and cisplatin, in patients with non-small cell lung cancer (NSCLC). The one-year survival rate for the nine patients that received at least one dose of OGX-011 in combination with chemotherapy was 67 percent. All but one of the nine patients showed either a partial response defined by a greater than or equal to 30 percent tumor size reduction, or stable disease defined by less than 30 percent tumor size reduction. Of the 55 percent of patients reported as stable disease, tumor reduction ranged from 10.3 percent to 29.7 percent. While patient evaluation is still ongoing, the median time for follow-up is 12.7 months (range 11.8 to 16.6 months) and the median time for survival has not yet been reached. OncoGenex is developing OGX-011 in collaboration with Isis Pharmaceuticals Inc. (NASDAQ:ISIS ).
"While this study was designed principally to evaluate safety in a limited number of patients, we are encouraged by the median and one-year survival rates to date," said Janessa Laskin, M.D., study chair and a medical oncologist at BC Cancer Agency. "These rates compare quite favorably with the median survival of 8 to 11 months and the one-year survival rates of 32 to 45 percent reported in eight randomized phase III studies involving over 1500 patients using a platinum-based regimen plus gemcitabine as first-line chemotherapy for NSCLC."
The investigators concluded that OGX-011 in combination with gemcitabine/cisplatin was well tolerated at the doses studied and most toxicities were typical for gemcitabine/cisplatin. The majority of the events (91 percent) were grade 1 and grade 2. The most common adverse events were constipation, change in taste, fatigue and chills. The most common grade 3 or 4 events were hematological (60 percent) and hyponatremia (30 percent). Six serious adverse events were seen in 4 patients (elevated creatinine, hypoxia, pneumonia, febrile neutropenia, anemia and pleural effusion). These toxicities were consistent with the adverse event profile for gemcitabine/cisplatin and/or a history of advanced NSCLC.
"These data support our ongoing phase II study which is evaluating OGX-011 in combination with gemcitabine and either cisplatin or carboplatin in a larger patient population of stage IIIB/IV non-small cell lung cancer patients," said Cindy Jacobs, Ph.D., M.D., Chief Medical Officer at OncoGenex. "Phase II studies evaluating OGX-011 in combination with neoadjuvant hormone therapy in prostate cancer, chemotherapy in hormone refractory prostate cancer, and chemotherapy in advanced breast cancer are also ongoing."
OGX-011 is a second-generation antisense drug that works by blocking or inhibiting the production of clusterin, thereby impairing the cancer cells' survival mechanism and enhancing the effectiveness of standard chemotherapy. Numerous laboratory studies have shown that blocking the production of the clusterin protein with OGX-011 facilitates the induction of cell death through standard therapies, enhances tumor regression and significantly delays disease progression. Studies to date have shown that in each case this novel combination strategy provides better treatment outcome than standard therapy alone.
The partnership between OncoGenex and Isis for the development of OGX-011 combines OncoGenex's proprietary antisense position in inhibitors to the target, clusterin, with Isis' proprietary second-generation antisense chemistry called 2'-O-methoxyethyl. Second-generation antisense drugs offer greater potency, enhanced tolerability, and improved dosing convenience compared to first-generation antisense drugs.
About Non-Small Cell Lung Cancer
According to the 2003 Onkos Report on Non-Small Cell Lung Cancer by Decision Resources, lung cancer accounts for 25 percent of all cancer deaths in women and more than 30 percent of all cancer deaths in men. It is one of the most common cancers in industrialized nations and an increasing problem in developing countries. NSCLC, a disease that encompasses several types, accounts for 80 to 85 percent of lung cancers. Because only a minority of patients live for more than one year after diagnosis and the five-year survival rate is less than 15 percent, NSCLC is characterized by a substantial unmet need for more effective therapies that can extend survival. Chemotherapy, with or without radiotherapy, is the standard of care in late-stage disease, where it is used primarily to prolong survival time and palliate symptoms. The prevalence of Stage III and IV patients in the major pharmaceutical markets (US, Europe, Japan, and Canada) is estimated at 219,694, or roughly 220,000 non-small cell lung cancer patients.
About OncoGenex Technologies
OncoGenex is committed to the development of next-generation cancer therapeutics for patients with drug-resistant and metastatic cancers. OncoGenex's oncology product candidates are being developed with intent to increase survival and improve the quality of life for cancer patients by enhancing the effectiveness of today's standard cancer therapies. The company's lead drug candidate, OGX-011, is currently in multiple Phase II studies investigating the potential to improve treatment outcomes for patients with prostate cancer, non-small cell lung cancer and breast cancer. More information on OncoGenex and its rapidly advancing pipeline of cancer drug programs can be found online at www.oncogenex.ca.
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