Cerulean Pharma Doses First Patient in 2a Portion of Phase 1/2a Study of CRLX301- Cerulean Pharma (CERU) announced that the first patient has been dosed in the 2a portion of its Phase 1/2a study evaluating nanoparticle-drug conjugate (NDC) CRLX301 in patients with advanced solid tumors. The 2a portion of the trial consists of 2 stages. The first will enroll will enroll up to eight subjects in each dosing schedule and is designed to further establish the safety and tolerability of the dosing schedules and to provide additional data on pharmacokinetics, pharmacodynamics and antitumor activity. The second stage will enroll up to 36 additional subjects with specific tumor types using the optimal dosing schedule. The company plans to advance into a pivotal study once the preferred dosing regimen and indication have been identified.
Teva and AstraZeneca Settle Patent Dispute- AstraZeneca (AZN) and Teva Pharmaceuticals USA (TEVA) have settled a patent infringement litigation. The settlement allows Teva to market a generic version of diabetes med BYETTA (exenatide) injection beginning October 15, 2017 or earlier under certain circumstances.
Innocoll Completes Enrollment in COACT-1 and COACT-2- Innocoll Holdings Plc (INNL) announced that it has completed patient enrollment in two Phase 3 clinical trials, COACT-1 (U.S.) and COACT-2 (Europe, Australia, U.S.), assessing QIDP-tagged COGENZIA (gentamicin-collagen topical matrix) for the treatment of diabetic foot infections. COACT-1 enrolled ~610 patients and COACT-2 ~525. Top-line data should be available in late Q3 or early Q4. If all goes well, the company will submit marketing applications in the U.S. and Europe. The primary endpoint of each study is the clinical cure rate 10 days after treatment.
Reata Reports Encouraging Data from Mid-Stage Extension Study for Lead Product Candidate- Reata Pharmaceuticals (RETA) announced that interim data from an extension Phase 2 trial, LARIAT, evaluating its lead product candidate bardoxolone methyl (bard) in pulmonary arterial hypertension (PAH), showed a sustained treatment effect. Specifically, the increase in six-minute walk distance (6MWD) demonstrated by bard-treated patients at week 16 was "not significantly different" through 32 weeks. In addition, bard-treated patients with connective tissue disease-associated PAH showed similar sustained results through week 32. The company plans to submit the data for presentation at a future medical conference. A Phase 3 study, CATALYST, is set to commence shortly.
Regulus Announces Debt Financing- Regulus Therapeutics (RGLS) announced that it has signed a loan and security agreement with Oxford Finance LLC for up to $30M in a series of term loans. The company borrowed $20 million at 8.51% + 30-day U.S. Dollar LIBOR on Thursday itself. The remaining $10M may be borrowed following the achievement of the milestone of positive interim safety and efficacy data from a Phase 2 clinical trial evaluating RG-101 and GlaxoSmithKline’s (GSK) oral GSK 175 for the treatment of hepatitis C virus infection no later than March 31, 2017.