Collaborators seek MS biomarkers

Biogen Idec and Regulus Therapeutics to look for microRNAs as biomarkers for multiple sclerosis

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LA JOLLA, Calif.—Regulus Therapeutics Inc. has entered intocollaboration with Biogen Idec to identify microRNAs as biomarkers for multiplesclerosis (MS). Per the transaction, Biogen Idec will make an investment inRegulus in addition to upfront and milestone payments.
The key objective of the collaboration is to identifymicroRNA biomarkers in the blood of patients with MS. Regulus believes thatmicroRNA biomarkers may be used to select optimal patient segments in clinicaltrials, develop companion diagnostics and monitor disease progression orrelapse.
Regulus, a biopharmaceutical company founded by AlnylamPharmaceuticals and Isis Pharmaceuticals, announced in August that it has fileda registration statement on Form S-1 with the U.S. Securities and ExchangeCommission relating to a proposed initial public offering of shares of itscommon stock. Neither the number of shares to be offered nor the price rangehad been determined at that time. Although left unstated—all Regulus offeredwas that the "company's executives are not available for comments at thistime"—it is apparently due to the pending Regulus IPO that neither Regulus norBiogen would comment further on their collaborative efforts.
Their joint statement read: "Utilizing innovative technologysuch as biomarkers can help us make more informed decisions earlier in clinicaldevelopment and is key to our overall company strategy to enhance early-stagediscovery efforts. We're excited to collaborate with Regulus to seek toidentify biomarkers in MS patients, and are hopeful it can speed the work we'redoing to bring new, effective treatments to market for patients with MS."
"Regulus is delighted to form a collaboration with BiogenIdec, a biotechnology pioneer with more than 30 years of innovativecontributions to the industry," says Dr. Garry E. Menzel, chief operatingofficer and executive vice president of finance at Regulus. "This collaborationallows us to further explore our proprietary microRNA biomarker platform withBiogen Idec's additional resources and expertise. We believe thatidentification of microRNAs as biomarkers for multiple sclerosis may advancethe treatment of this devastating disease."
Regulus is advancing multiple microRNA therapeutic programsto the clinic in the areas of fibrosis, HCV infection, immuno-inflammatorydisease, metabolic disease and oncology. MicroRNAs are small RNA molecules,typically 20 to 25 nucleotides in length, which do not encode proteins, butinstead regulate gene expression. More than 500 microRNAs have been identifiedin the human genome, and more than one-third of all human genes are believed tobe regulated by microRNAs. MicroRNA expression, or function, has been shown tobe significantly altered in many disease states, including oncology, fibrosisand metabolic diseases. Regulus believes that microRNAs are clinically relevanttherapeutic targets and may be ideally suited as biomarkers for these diseasestates and others, like MS. Emerging data has demonstrated that microRNAsignatures in blood can mimic the expression profile observed in diseasetissues. Regulus has a comprehensive intellectual property estate andoligonucleotide technology know-how.
In addition to its collaboration with Biogen Idec, Regulushas formed strategic alliances with AstraZeneca, GlaxoSmithKline and Sanofi.Earlier this year, the company presented data from its proprietary lead programtargeting microRNA-33a/b (miR-33a/b), which is currently in preclinicaldevelopment for the treatment of atherosclerosis.

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