EuroBiotech: More Articles of Note

A pile of newspapers

> Pluristem Therapeutics ($PSTI) secured an $8 million ($9 million) grant from the European Union for a Phase III trial of its placenta-based cell therapy in patients with critical limb ischemia. The study, which Pluristem is conducting in collaboration with a consortium of European research centers, is aiming to enroll 250 patients and give them either 300 million cells or a placebo. Pluristem has set time to amputation and death as the primary endpoint. Release

> Moberg Pharma (OMX:MOB) secured clearance to start a Phase III trial of MOB-015 in the U.S. and Canada. The study will look at MOB-015, a topical formulation of terbinafine, in patients with the fungal infection onychomycosis. Terbinafine is already given orally but, by putting the ingredient into a topical formulation, Moberg thinks it can avoid some of the safety issues associated with the drug. Release

> BioLineRx ($BLRX) struck another deal to assess BL-8040 in combination with Merck’s ($MRK) Keytruda in patients with pancreatic cancer. The agreement, which comes 8 months after BioLineRx first unveiled its deal with Merck, will see MD Anderson Cancer Center assess the combination in a Phase II investigator-sponsored trial. Release


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> Summit Therapeutics ($SMMT) posted Phase I data on a new formulation of its Duchenne muscular dystrophy (DMD) candidate ezutromid. With the formulation achieving higher plasma concentrations than the existing candidate, despite being given at lower doses, Summit has decided to work the new version into its development strategy. Up to one-quarter of patients in the ongoing Phase II study will receive the new formulation. If data from that study pass muster, Summit plans to start a pivotal trial in the back half of next year. Release

> Affimed ($AFMD) committed another €1.5 million in Series A funding to its West Coast collaborator Amphivena Therapeutics. The German biotech decided to make the money available after Johnson & Johnson ($JNJ) declined to take up its option to acquire Amphivena. With J&J backing away from the deal, Amphivena now faces the prospect of advancing its CD33-CD3 bispecific antibody through Phase I unpartnered. Release

> A Phase III trial of PharmaMar’s (BME:PHM) PM1183 gained clearance to continue following a futility analysis. An independent data monitoring committee backed the continuation of the study after taking a look at data generated by the first 210 patients to enroll in the trial. Having come through the futility analysis PharmaMar will continue to enroll patients with platinum-resistant ovarian cancer until 420 people are in the study. Release

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