ANIK Makes Regulatory Submissions, ADXS Joins Hands With INCY, IMDZ On Watch

(RTTNews) - Advaxis Inc. (ADXS) has entered into a clinical trial collaboration agreement with Incyte Corp. (INCY) to evaluate the investigational combination of two novel cancer immunotherapies for early stage cervical cancer.

Accordingly, a phase II multicenter, open-label, preoperative window-study will evaluate the safety and efficacy of Advaxis's ADXS-HPV as a monotherapy and in combination with Incyte's Epacadostat in approximately 20 patients with Stage I-IIa human papillomavirus (HPV)-associated cervical cancer.

ADXS closed Wednesday's trading at $7.46, up 6.27%.

Anika Therapeutics Inc. (ANIK) has filed regulatory submissions in the United States and Europe seeking approval of Cingal, the company's novel hyaluronic acid plus steroid single-injection treatment for osteoarthritis of the knee.

In addition to the United States and Europe, the company plans to commercialize Cingal in other key markets in the world.

ANIK closed Wednesday's trading at $40.61, up 1.63%.

Heron Therapeutics Inc. (HRTX) has initiated a phase I clinical trial of HTX-011, which is being developed for the treatment of post-operative pain. The company expects to report initial results from the trial before the end of the first quarter of 2015.

A series of phase 1b/2 studies of HTX-011 in several post-surgical pain settings are planned, and the company anticipates initiating the first of the studies in the second quarter, with data expected before the end of 2015.

HRTX closed Wednesday's trading at $9.14, down 2.04%.

Immune Design (IMDZ) has started a phase I clinical trial of G100 in combination with radiation therapy in patients with metastatic sarcoma.

The company's other drug candidates under phase I testing include, LV305, CMB305, and G305 for the treatment of solid tumor types, such as breast cancer, melanoma, non-small cell lung cancer, ovarian cancer, or sarcoma.

The company went public on July 24, 2014, pricing its shares at $12.00 each.

IMDZ closed Wednesday's trading at $23.17, down 2.28%.

Mast Therapeutics Inc.'s (MSTX) lead product candidate in heart failure Vepoloxamer has demonstrated superiority both alone and in combination with tissue plasminogen activator (tPA) compared to tPA alone and saline controls in a model of embolic stroke with delayed administration of tPA.

Importantly, treatment with Vepoloxamer alone and in combination with tPA did not increase the incidence of haemorrhage, added the company.

The company is currently enrolling patients in a phase 2 study of Vepoloxamer in combination with recombinant tPA in patients with acute limb ischemia to assess whether Vepoloxamer can accelerate *time-to-reperfusion. (*The time to reperfusion determines the extent of reversible and irreversible myocardial injury). The results of this trial are expected next year.

MSTX closed Wednesday's trading at $0.46, up 4.12%. In after-hours, the stock gained 5.49% to $0.48.

Novogen Limited (NVGN) has lodged final specifications of a patent that covers the company's first family of super-benzopyran compounds that includes leading drug candidates TRXE-002, TRXE-009 and TRXE-0025, which have the ability to kill cancer stem cells.

The company is also working to get the above drug candidates successfully come through their large-scale manufacturing process ahead of a number of clinical trials over the next 12 months. There have been no manufacturing hurdles, confirming the simpler manufacturing process that is a key part of the patent, noted the company.

NVGN closed Wednesday's trading 3.97% higher at $2.62. In after-hours, the stock was up 6.49% at $2.79.

Oncolytics Biotech Inc.'s (ONCY) lead product candidate, REOLYSIN, for the treatment of ovarian cancer has been granted Orphan Drug Designation by the FDA.

A phase II trial of weekly paclitaxel versus weekly paclitaxel with REOLYSIN in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer is ongoing.

ONCY closed Wednesday's trading at $0.47, up 1.00%.