WALTHAM, MA – January 7, 2015 – Interleukin Genetics, Inc. (OTCQB: ILIU) announced today an agreement with Isis Pharmaceuticals Inc. to provide genetic testing services for Isis’ Phase 2 clinical study evaluating its novel therapeutic, ISIS-APO(a)Rx, in patients with high lipoprotein(a), or Lp(a), an independent risk factor for cardiovascular disease.
Patients with high levels of Lp(a) have an increased risk of atherosclerosis, coronary heart disease, aortic stenosis, heart attack and stroke. ISIS-APO(a)Rx is designed to reduce Lp(a) by inhibiting production of the apolipoprotein(a) component of Lp(a). Isis is developing ISIS-APO(a)Rx to treat patients with high Lp(a) levels who are at high risk of experiencing life-threatening cardiovascular events.
“We look forward to working with Isis and the study investigators, using our current genetic test panels for inflammatory and metabolic diseases to explore genetic factors that may add value in this clinical trial,” said Kenneth S. Kornman, DDS, PhD, Chief Executive Officer of Interleukin. “Recent work (Tsimikas et al. 2014) has shown that the combination of elevated Lp(a) levels in patients who over-produce interleukin-1 was a strong predictor of secondary cardiovascular events. In this study, we were able to identify patients with elevated Lp(a) levels who also over-produced interleukin-1 using our Interleukin Genetics test. This is a prime example of how Interleukin Genetics works with pharmaceutical companies to employ complementary genetic tests designed to improve clinical outcomes.”
According to Isis, the Phase 2 study is a randomized, placebo-controlled, dose-titration study evaluating the safety and efficacy of ISIS-APO(a)Rx. The 12-week study will evaluate 100 mg, 200 mg and 300 mg doses of ISIS-APO(a)Rx in approximately 60 patients with Lp(a) levels of 50 mg/dL or greater. According to the National Institutes of Health, an average normal Lp(a) level is less than 30 mg/dL and the European Atherosclerosis Society recommends that Lp(a) levels be less than or equal to 50 mg/dL.
For more information about the ongoing Isis clinical study, please visit: http://clinicaltrials.gov/ct2/show/NCT02160899.
About Lp(a)
Lp(a) is a lipoprotein particle that is assembled in the liver that consists of an LDL-C-like particle and apolipoprotein(a). Lp(a) levels in blood can vary greatly between individuals due primarily to genetic variations in the gene that encodes for apolipoprotein(a). Lp(a) levels are genetically determined and remain constant throughout the life of the individual. As a result, diet and lifestyle changes have little impact on Lp(a) levels and current therapies are not able to adequately reduce elevated levels of Lp(a) to recommended levels in patients who have high Lp(a) levels.
About Interleukin Genetics
Interleukin Genetics, Inc. (OTCQB: ILIU) develops and markets proprietary genetic tests for chronic diseases and health related conditions. The products empower individuals to prevent certain chronic conditions and manage their existing health and wellness through genetic-based insights with actionable guidance. Interleukin Genetics leverages its research, intellectual property and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The Company markets its tests through partnerships with health and wellness companies, healthcare professionals and other distribution channels. Interleukin Genetics’ lead products include its proprietary PerioPredict® genetic risk panel for periodontal disease and tooth loss susceptibility available through dentists, and the Inherent Health Weight Management Genetic Test that identifies the most effective diet program for an individual based on genetics. Interleukin Genetics is headquartered in Waltham, MA and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratories Improvements Amendments (CLIA). For more information, please visit www.ilgenetics.com.
Forward-Looking Statements
Certain statements contained herein are “forward-looking” statements, including statements related to the potential for the Company’s genetic test to add value in ISIS’ clinical trial. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company’s annual report on Form 10-K for the year ended December 31, 2013 and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.
Interleukin Genetics Contacts:
Matthew Haines/Susie Kim
Argot Partners
(212) 600-1902
matthew@argotpartners.com
susie@argotpartners.com