OncoGenex’s custirsen Falls Short of Showing desired results in Phase 3 Study-OncoGenex $OGXI reported on Thursday that its Phase 3 study, ENSPIRIT, evaluating lead product candidate custirsen, in combination with the chemo agent docetaxel in patients with advanced non-small lung cancer (NSCLC) who had progressed after initial chemotherapy, failed to show a statistically valid increase in median overall survival (OS) compared to docotaxel taken alone (9.0 months vs. 7.9 months; p=0.178). The stock had plunged two month ago after it failed in another late-stage study in treatment-resistant prostate cancer. The company is currently looking at strategic options.
Bluebird’s refined LentiGlobin manufacturing process shows higher efficiency-Bluebird bio $BLUE announced that it new LentiGlobin manufacturing process (process 2), based on the addition of two transduction enhancers, produces an average three-fold increase in vector-positive cells and vector copy number (VCN) compared to its original process (process 1). The company said that the Process 2 has been successfully scaled up for clinical manufacturing; and, hereafter all LentiGlobin clinical trials will rely on the new process.
FDA’s Decision on Egalet’s NDA won’t be met on Friday-Egalet Corp $EGLT slumped in afterhours amid increased trading volume in response to its announcement that the FDA will not make its decision, the PDUFA date, regarding its New Drug Application (NDA) seeking approval of ARYMO ER (morphine sulfate) for the management of severe pain. The drug-maker said that FDA requires more time to review the filing, just as they did with other abuse-deterrent opioid NDAs. However, the authority has added no additional data or scientific information is needed for the application.
TG Therapeutics Files Request with FDA to alter protocol for Lead candidate TG-110-TG Therapeutics $TGTX slumped amid increased trading volume after it announced that it has filed a request with the FDA to amend the protocol in its Phase 3 clinical trial, GENUINE, evaluating lead product candidate TG-1101 in patients with high-risk relapsed/refractory chronic lymphocytic leukemia (CLL). The altered protocol, if approved, will drop progression-free survival (PFS) as an efficacy endpoint (Part II of the study) with overall response rate (ORR) serving as the sole primary endpoint (Part I). Enrollment in the revised trial should be finalized this quarter with top-line data likely in H1 2017.
Clinical Hold on Aptose Bio’s APTO-253 to Stay-Nano-cap stock, Aptose Biosciences $APTO plunged in response to its announcement that the FDA’s clinical hold on its Phase 1b clinical trial evaluating lead product candidate APTO-253 will continue until it submits additional data. The regulatory authority put the candidate on clinical hold in November 2015 after problems with an IV infusion pump surfaced at a clinical trial site.
Flex Pharma to initiate Mid-stage Trial of FLX-787 for nocturnal leg cramps in H1 2017-Flex Pharma $FLKS announced its clinical development plan for FLX-787 for the treatment of nocturnal leg cramps (NLCs). Once it receives a feedback from the FDA, it plans a parallel design Phase 2 study, which should start in H1 2017 after its Investigational New Drug (IND) application has been filed and accepted. Flex plans to market FLX-787 as a dietary supplement for reducing NLCs. According to the company, its treatment stimulates the primary sensory neurons in the mouth, stomach and esophagus by activating transient receptor potential (TRP) cation channel receptors. TRP activators are recognized as safe by the FDA when used in food products. FLX-787 is also being developed for the treatment of multiple sclerosis and amyotrophic lateral sclerosis.