Mirna Therapeutics Suspends Early-Stage Trial of Lead Candidate; Shares Tumble- Shares of normally thinly traded Mirna Therapeutics $MIRN saw increased trading volume even as shares slumped more than 25% after it announced voluntary suspension of enrollment and dosing in its Phase 1 study on a lead candidate MRX34. The drug-maker took the decision after it found five immune related severe adverse events in subjects given with MRX34. It said that now it will not be starting a translational medicine study of the lead candidate in melanoma patients, which was planned later this year. Meanwhile, the company is evaluating the data of trails and will discuss the outcome with its advisors and FDA.
Aimmune Top-Line Data on Phase 3 Study of Lead Candidate AR101 Likely in Q4 2017- Aimmune Therapeutics $AIMT announced on Tuesday that it completed its North America enrollment target for its Phase 3 study, PALISADE, evaluating lead product candidate AR101 for the desensitization of patients allergy to peanuts. Final enrollment would be 425 - 450, compared to the original target of 350. Enrollment in Europe should be completed by year end. Top-line data should be available in Q4 2017.Enrollment in another study, RAMSES, intended to build real-world experience with AR101, will start in Q1 2017.
Shire Unenthusiastic with Myelofibrosis Candidate after Mixed Results- Shire plc $SHPG looks unenthusiastic to continue with its study on myelofibrosis candidate pacritinib following mixed results in a mid-stage study. Earlier in February, it received a set-back after FDA imposed hold on full clinical trial due to excessive deaths in the enrollment group caused by intracranial hemorrhage, cardiac failure and cardiac arrest.
Amgen's Repatha Meets Success in late-stage coronary plaque imaging study- A Phase 3 clinical trial, GLAGOV, evaluating the capability of Amgen's $AMGN anti-cholesterol med Repatha (evolocumab) to alter the buildup of artery plaque met its primary and secondary endpoints. Detailed outcome will be discussed on Tuesday, November 15 at the American Heart Association Scientific Sessions in New Orleans, LA.
Synthetic Biologics completes enrollment in mid-stage study of ribaxamase for prevention of C. diff infection- Synthetic Biologics $SYN announced that ensuing the conclusion of its earlier planned interim analysis by an independent Interim Analysis Committee (IAC), enrollment has been finalized in its Phase 2b randomized, placebo-controlled, proof-of-concept clinical trial evaluating SYN-004 (ribaxamase) for the prevention of Clostridium difficile (C. diff) infection. Top-line data should be available in Q1 2017.
Teva, Regeneron Aims to Target Lilly/Pfizer Pain Treatment- Israeli drug-maker Teva Pharmaceutical $TEVA Industries and Regeneron Pharmaceuticals Inc $REGN announced on Tuesday that they intend to jointly develop Regeneron’’s experimental new type of pain treatment. If the clinical trials are successful and approved by the regulators, they would jointly market the medicine, according to a Reuters’ report. The injectable treatment, branded as fasinumab, blocks Nerve Growth Factor (NGF), a protein responsible for transmitting pain signals. In the press release, the drug-makers said that its new mechanism of action could be a non-addictive a substitute to opioids. Currently, late-stage clinical trials are being conducted for evaluating its effectiveness to cure osteoarthritis pain and mid-stage studies for chronic low back pain. Rival drug-makers Elli Lilly $LLY and Pfizer Inc. $PFE are planning to get regulatory approval for a similar drug, tanezumab, by 2018.
BioLineRx Starts Mid-stage Study on Pancreatic Cancer - BioLineRx $BLRX started a Phase 2a study, COMBAT, evaluating lead product candidate BL-8040 and Merck's $MRK KEYTRUDA (pembrolizumab) for curing metastatic pancreatic adenocarcinoma. The study involves 30 subjects. It would be an open-label, single-arm trail for assessing the efficacy of the drug. The trial is being conducted under the companies' January immunotherapy collaboration. According to ClinicalTrials.gov, the expected trial completion date is December 2018.