QURE Cuts A Deal, CYTX Gets China FDA Nod, OCUL Blacked Out, VTR Opens Wallet

(RTTNews) - Advaxis Inc. (ADXS) is entering into a clinical trial collaboration agreement with Radiation Therapy Oncology Group Foundation to evaluate the safety and efficacy of its lead cancer immunotherapy, ADXS-HPV, in a pivotal phase 2/3 anal cancer trial.

Under the proposed collaboration, RTOG Foundation will conduct an adequate and well-controlled phase 2/3 clinical trial of concurrent chemotherapy of mitomycin C/5FU and radiation therapy, or CCRT, compared to CCRT combined with Advaxis' ADXS-HPV in the adjuvant treatment of high-risk locally advanced anal cancer.

ADXS touched a new high of $16.44 on Monday before closing the day's trading at $16.11.

Cytori Therapeutics Inc. (CYTX) rose more than 13% on Monday following regulatory clearance for its Celution System in China. The regulatory clearance in China triggers a substantial 2015 product purchase order for Cytori from its exclusive licensee, Lorem Vascular.

Celution is a medical device which enables stem cells to be derived from a patient's own adipose tissue for therapeutic uses. Lorem Vascular will begin product launch of Celution in key hospitals in China immediately.

The Celution System is being used in clinical research and under limited approvals in Europe and Japan, where it is registered as a medical device.

CYTX closed Monday's trading 13.79% higher at $1.32.

Shares of Ocular Therapeutix Inc. (OCUL) tumbled more than 33% in extended trading on Monday after the company announced that its second of two phase III clinical trials evaluating its lead product candidate OTX-DP for the treatment of post-surgical ocular inflammation and pain did not meet the primary efficacy endpoint for inflammatory cells. The trial did meet the primary efficacy endpoint for pain.

However, for the trial to be considered successful, the two primary efficacy endpoints namely statistically significant differences between the treatment group and the placebo group for the absence of pain on day 8 and absence of inflammatory cells on day 14 need to have been met.

In the first phase III clinical trial of OTX-DP, the results of which were announced last month, both primary efficacy endpoints, achievied a statistically significant improvement in the reduction of inflammatory cells on day 14 and pain on day 8.

The company plans to meet with the FDA to discuss the phase III OTX-DP clinical trial results and chart the appropriate path forward.

A phase IIb clinical trial of OTX-TP (Sustained Release Travoprost), for the treatment of glaucoma and ocular hypertension, is underway, and top-line efficacy data are expected in the fourth quarter of 2015.

OCUL closed Monday's trading at $38.30, down 6.33%. In after-hours, the stock plunged 33.29% to $25.55.

uniQure N.V. (QURE) skyrocketed 47% on Monday following a strategic collaboaration with Bristol-Myers Squibb (BMY) to develop gene therapies for cardiovascular diseases.

Under the terms of the agreement, Bristol-Myers Squibb will make an upfront payment of $50 million, an initial equity investment of $32 million for a 4.9% stake in uniQure and a $15 million payment for selection of three collaboration targets. The agreement also entitles Bristol-Myers-Squibb to acquire an additional 5.0% ownership in uniQure before the end of this year.

QURE touched a new high of $35.50 on Monday before closing the day's trading at $33.61, up 47.03%. We had alerted this stock to our premium subscribers on December 3, 2014, when it was trading around $13.

Ventas Inc. (VTR) has agreed to acquire privately-owned Ardent Medical Services Inc., a nationwide provider of hospital and health care services, for $1.75 billion in cash.

The transaction, which is scheduled to close mid-year 2015, is expected to be immediately accretive to Ventas's normalized FFO per share by $0.08 to $0.10 (cash) in the first full year after close.

VTR closed Monday's trading at $76.90, up 5.01%.