Bristol-Myers Squibb Co. (BMY) has entered into a clinical collaboration agreement with Eli Lilly and Co. (LLY) to explore combination regimens from its immuno-oncology portfolio with other mechanisms of action that may accelerate the development of new treatment options for patients.
As per the agreement terms, a phase 1/2 trial will evaluate Bristol-Myers Squibb's approved immunotherapy Opdivo in combination with Lilly's investigational Galunisertib as a potential treatment option for patients with advanced (metastatic and/or unresectable) glioblastoma, hepatocellular carcinoma and non-small cell lung cancer.
Opdivo is approved by FDA for intravenous use for the treatment of patients with unresectable or metastatic melanoma while Galunisertib is currently under investigation as an oral treatment for advanced/metastatic malignancies, including phase 2 evaluation in hepatocellular carcinoma, myelodysplastic syndromes (MDS), glioblastoma, and pancreatic cancer.
In other related news, Lilly has also entered into a collaboration agreement with Merck & Co. Inc. (MRK) to evaluate the safety, tolerability and efficacy of Merck's KEYTRUDA in combination with Lilly compounds in multiple clinical trials.
Merck's KEYTRUDA was granted accelerated approval by FDA last September for unresectable or metastatic melanoma with disease progression following Ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
BMY closed Tuesday's trading at $63.12, up 1.51%.
Celsus Therapeutics plc (CLTX) has completed enrollment in its phase II study evaluating the safety and efficacy of MRX-6 cream 2% in a pediatric population with mild to moderate atopic dermatitis.
The topline data from the trial are expected by end-February, 2015.
CLTX closed Tuesday's trading 10.39% higher at $5.95.
Cellular Dynamics International (ICEL) has entered into a research collaboration with privately-held Cord Blood Registry to reprogram newborn stem cells into induced pluripotent stem cells.
Cord Blood Registry, the world's largest cord blood bank, will provide multiple de-identified, research-donated and cryopreserved umbilical cord blood units as well as multiple de-identified units of mesenchymal stem cells (MSCs) isolated from previously cryopreserved cord tissue to Cellular Dynamics.
Cellular Dynamics will apply its proprietary episomal reprogramming technique to create induced pluripotent stem cells (iPSCs) from cells stored in Cord Blood Registry's bank.
Given the rate of clinical advancements in iPSCs and their capacity to differentiate into different tissues, the ability to create a pluripotent stem cell from newborn stem cells has the potential to become a very valuable resource to treat disease, noted Bob Palay, Chairman and CEO of Cellular Dynamics.
ICEL closed Tuesday's trading at $5.97, up 8.15%.
Privately-held Immuno Technologies Inc., which has been working in collaboration with OPKO Diagnostics LLC, a division of OPKO Health Inc. (OPK) and Columbia University in the City of New York, has been awarded a $3 million grant by the National Institutes of Health to develop a rapid diagnostic test for Lyme disease.
The rapid Lyme disease test will be based upon novel antigens that increase the specificity and sensitivity of the current laboratory assays and improve discrimination between early and late stage disease using OPKO's Claros1 analyzer.
OPK closed Tuesday's trading at $10.19, down 0.78%.
HeartWare International Inc. (HTWR) has begun the first clinical trial of a full-support ventricular assist device in which HeartWare Ventricular Assist System, featuring the HVAD Pump, is implanted through a less-invasive thoracotomy procedure in patients with end-stage heart failure who are awaiting a heart transplant.
Currently, commercially available ventricular assist systems are only approved by the FDA for use with implantation via median sternotomy, a common surgical approach in cardiac surgery which utilizes a vertical incision through the center of the patient's chest. With the less-invasive thoracotomy approach, the HVAD Pump, which is smaller than other contemporary devices, is implanted using a small lateral thoracotomy incision between the patient's ribs on the left side of the chest.
The study, dubbed HVAD LATERAL Study, is designed to enroll up to 120 patients at 30 U.S. hospitals.
HTWR closed Tuesday's trading at $80, up 1.36%.
InspireMD Inc. (NSPR) will be presenting more detailed data from its CGuard CARENET trial at the upcoming LINC (Leipzig InterveNtional Course) meeting in Leipzig, Germany on Tuesday, January 27, 2015.
The CARENET clinical study is a multi-specialty trial that is designed to provide data and evidence of the CGuard carotid embolic protection system to better understand the complexities and challenges of patients that experience carotid artery disease. The objective of the CARENET study is to evaluate the safety and efficacy of the CGuard system in the treatment of carotid lesions in consecutive patients suitable for carotid artery stenting.
NSPR closed Tuesday's trading at $0.84, down 2.19%.
ZELTIQ Aesthetics Inc.(ZLTQ) expects fourth quarter revenue to be roughly 44 per cent higher compared to the year-ago quarter, thanks to the company's ability to expand and grow the large, underpenetrated market for non-invasive body sculpting.
The total revenue for the fourth quarter 2014 is expected to be in the range of $51 million to $52 million, up from $35.8 million in the fourth quarter 2013. The total revenue for the full year 2014 is anticipated to be approximately $175 million to $176 million, compared to total net revenue for the full year 2013 of $111.6 million.
The company is currently projecting full year 2015 revenue of approximately $230 million which would represent over 30% growth compared to full year 2014.
ZLTQ closed Tuesday's trading at $27.90, down 3.36%. In after-hours, the stock was up 6.34% at $29.67.
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