Innovation Pharmaceuticals Inc (IPIX)

[DaubersUP]

IV sucks
60 minutes each time radiation is given. Ouch........


Galera Therapeutics, a private company, rattled the OM space at the end of February by becoming the first company to receive a Breakthrough Therapy designation from the FDA for an OM drug candidate. Like Fast Track, the designation is designed to expedite development of therapies targeting areas in serious need. Breakthrough Therapy comes with all the benefits of a Fast Track in addition to intensive guidance from the FDA on an efficient drug development program, including help from senior FDA managers.

Since the program’s inception in 2012, the FDA has only awarded about 210 Breakthrough designations. Galera’s designation for OM speaks volumes about the FDA’s sense of urgency to develop new drugs for the indication.

Galera received the designation based upon its successful Phase 2b trial of its lead drug candidate, the intravenous drug GC4419, a highly selective and potent small molecule dismutase mimetic for SOM. The 223-patient trial met its primary endpoint with HNC patients receiving chemotherapy (cisplatin) and radiation in the GC4419 group demonstrating a significant reduction in the duration of SOM.

In the “intent-to-treat” population, patients administered the higher dose of GC4419 (90 mg) experienced a SOM duration of 1.5 days, versus 19 days for patients in the placebo group, a 92% reduction. Why placebo patients in the Galera trial had 19 days of SOM versus only 5.5 days for the IPIX trial is unexplainable without a much deeper look under the hood.

Galera’s trial also met its secondary endpoints in reducing the incidence of SOM by 34% (36% in patients receiving up to 60 Gy of radiation) and reducing the incidence of Grade 4 SOM by 47%.

Like IPIX, the data looks good and a Phase 3 study is necessary, but Galera could face a significant hurdle with the 60-minute IV administration every time radiation therapy is given. While it can lower the chances of SOM, it’s not the optimal delivery method for patients and carries a sizeable price tag to complete versus oral administration. Regardless, these are still two front runners in the business








http://www.galeratx.com/data-223-patient-phase-2b-clinical-trial-galera-therapeutics-gc4419-presented-2018-american-society-clinical-oncology-asco-annual-meeting