dera Pharmaceuticals, Inc. (Nasdaq: IDRA) announced on Friday, of all days, that it will delay initiating its planned Phase 2 clinical trial of IMO-2125 plus ribavirin in treatment-naive, genotype 1 hepatitis C virus (HCV) patients, based on preliminary data from a 26-week nonclinical toxicology study of IMO-2125 in rodents. Preliminary analysis of the histology data from the rodent study showed instances of atypical lymphocytic proliferation. They expect data from the study and additional histology data from the rodent study during the second half of 2011 and will make a decision regarding the Phase 2 trial once the rodent data is evaluated.
A.P. Pharma, Inc. (OTCQB: APPA), recently delisted from NASDAQ, said today they expect to resubmit their APF530 NDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first half of 2012.
XenoPort, Inc. (Nasdaq: XNPT) announced today that it had reached agreement with the FDA on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of arbaclofen placarbil (AP), previously known as XP19986, as a potential treatment of spasticity in multiple sclerosis patients. XenoPort plans to initiate the pivotal Phase 3 clinical trial that is the subject of the SPA later this quarter. The entire treatment period will be 13 weeks.
As mentioned in the April tab in the FDA Calendar, Keryx Biopharmaceuticals (Nasdaq: KERX) will present the final dataset from the Phase 3 short-term clinical trial of Zerenex (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis at the National Kidney Foundation (NKF) Spring Clinical Meetings on April 28 (Thur). Top-line data was presented in November last year. The long-term trial is ongoing.