AGN To Face FDA In Q1-2016, DPRX Moves One Step Ahead, RPTP, VRX Open Wallets

(RTTNews) - Enrollment has commenced in a phase I/II clinical trial of Advaxis Inc.'s (ADXS) investigational Axalimogene filolisbac in combination with MedImmune's drug candidate Durvalumab for the treatment of patients with advanced, recurrent or refractory human papillomavirus-associated cervical cancer and HPV-associated head and neck cancer.

The study is designed to evaluate the safety and efficacy of Axalimogene filolisbac as a monotherapy and in combination with Durvalumab in approximately 66 patients. The primary efficacy endpoints include objective response rate and progression-free survival.

ADXS closed Thursday's trading at $14.21, down 4.57%.

Allergan plc's (AGN) resubmitted supplemental Biologics License Application for BOTOX for the treatment of lower limb spasticity in adults is scheduled to be reviewed by the FDA in the first quarter of 2016.

The FDA approved the expanded use of BOTOX for the treatment of adults with upper limb spasticity in April of this year.

Botox had sales of $2.23 billion last year, according to Bloomberg. In 2014, therapeutic sales accounted for approximately 55% of BOTOX sales while aesthetic sales accounted for approximately 45% of total BOTOX sales.

AGN closed Thursday's trading at $307.39, down 3.60%.

Dipexium Pharmaceuticals Inc.'s (DPRX) phase III trial of Locilex for the treatment of patients with mild infections of diabetic foot ulcers, dubbed OneStep-1, has passed the 50% enrollment milestone. An identical, phase III trial of Locilex, dubbed OneStep-2, is also underway.

OneStep-1 and OneStep-2 are designed to enroll 180 patients each. The company anticipates completing enrollment and filing a New Drug Application for Locilex in 2016.

DPRX closed Thursday's trading at $12.25, down 3.62%.

InVivo Therapeutics Holdings Corp.'s (NVIV) ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with acute thoracic spinal cord injury has enrolled the fourth patient.

This is the company's first clinical study of its investigational degradable polymer Neuro-Spinal Scaffold. The Investigational Device Exemption pilot study has been approved by the FDA and is intended to capture preliminary safety and effectiveness data of the Neuro-Spinal Scaffold in five subjects with acute thoracic spinal cord injury. Following the pilot trial, InVivo expects to conduct a pivotal study to obtain FDA approval to commence commercialization under a Humanitarian Device Exemption.

NVIV closed Thursday's trading at $10.90, up 0.18%.

Raptor Pharmaceutical Corp. (RPTP) has signed a definitive agreement with Tripex Pharmaceuticals to acquire Quinsair, the first inhaled fluoroquinolone therapy approved for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adults with cystic fibrosis, for about $453 million.

The deal, which expands the Raptor's portfolio of rare disease therapies, is expected to close in the third quarter of 2015.

Quinsair received marketing authorization by the European Commission and Health Canada in March 2015 and June 2015, respectively. Raptor plans to launch Quinsair in Europe and Canada in the first half of 2016, and to discuss the path to potential approval in the same indication in the U.S with the FDA in 2016.

RPTP closed Thursday's trading at $12.02, down 8.03%. In after hours, the stock was up 8.15% to $13.

Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO) has agreed to acquire privately-held Sprout Pharmaceuticals Inc. for approximately $1 billion in cash, plus a share of future profits based upon the achievement of certain milestone.

Sprout received FDA approval for its sexual desire disorder drug Addyi as recently as August 18, 2015. Valeant expects Addyi to be available in the United States in the fourth quarter of 2015.

The transaction is expected to close in the third quarter of 2015.

VRX closed Thursday's trading at $229.06, down 6.47%.

VBL Therapeutics (VBLT) announced that the first patient has been dosed in the company's pivotal phase III trial of VB-111, an intravenously-administered, gene-therapy biological agent, for the specific inhibition of tumor vascular growth, in recurrent glioblastoma.

The trial, dubbed GLOBE Study, is proceeding under a special protocol assessment granted by the FDA. Interim data from this trial is expected in the second half of 2016.

VBLT closed Thursday's trading at $5.03, down 3.82%.