Innovative Clinical Trial Implementation and Manufacturing Capacity Production Fueling Biotech Sector Growth
PALM BEACH, Florida, November 28, 2016 /PRNewswire/ --
Confidence within the biotech sector remains high post elections as companies strive to develop solutions to improve cancer clinical trials in the pursuit of advanced treatments and innovative therapies. Biotech stocks in focus this week include: Cellectar Biosciences, Inc. (NASDAQ: CLRB), Pfizer Inc. (NYSE: PFE), Heat Biologics, Inc. (NASDAQ: HTBX), AstraZeneca PLC (NYSE: AZN) and Gilead Sciences, Inc. (NASDAQ: GILD).
Cellectar Biosciences, Inc. (NASDAQ: CLRB), an oncology-focused, clinical stage biotechnology company, today announced it has selected Hamilton, Ontario-based Centre for Probe Development and Commercialization (CPDC), a well-respected GMP manufacturing organization specializing in radiopharmaceuticals, as a supplier of the company's lead phospholipid drug conjugate (PDC), CLR 131. Read this full Press Release and more news for CLRB at: http://marketnewsupdates.com/news/clrb.html
The company believes that CPDC will provide a cost-effective and long-term manufacturing solution. The partnership establishes manufacturing capacity at a level sufficient for both a pivotal trial and future large-scale commercial production. CPDC's development of further production capability for CLR 131 will significantly enhance the company's ability to support the anticipated clinical trial activity as it progresses through 2017 while also preparing for a pivotal study and, ultimately, commercialization.
"This partnership with CPDC signals an important milestone in the development of CLR 131; it reflects our confidence in the potential clinical utility of our lead compound and establishes an additional supply source as well as pivotal trial and commercial scale production," said Jim Caruso, president and CEO of Cellectar Biosciences. "As we prepare to initiate our NCI-supported Phase II trial of CLR 131 in multiple myeloma and other hematologic malignancies, it is imperative that we continue to identify optimal pathways to accelerate and further support its development."
In other Biotech and Big Pharma developments of note in the markets:
Pfizer Inc. (NYSE: PFE) earlier this month announced that detailed results from the Phase 3 PALOMA-2 trial were published in The New England Journal of Medicine. These data, presented at the 52nd American Society of Clinical Oncology (ASCO) Annual Meeting in June, further demonstrate the clinical benefit of IBRANCE® (palbociclib) as initial therapy for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. The PALOMA-2 study showed the combination of IBRANCE and letrozole extended progression-free survival (PFS), or the amount of time before tumor growth, by more than 10 months compared with letrozole plus placebo.
Heat Biologics, Inc. (NASDAQ: HTBX) shares jumped on Friday's shortened trading session closing at $2.49 on over 20 Million shares traded by the close. Heat Biologics, a leader in the development of gp96-based immunotherapies that are designed to activate a patient's immune system to fight cancer, also announced earlier this month that it will be reporting topline results from the Phase Ib study evaluating HS-110, in combination with Bristol-Myers Squibb's anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo®), for the treatment of non-small cell lung cancer (NSCLC), in a Mini Oral Session, at the International Society for the Study of Lung Cancer Annual Meeting, in Vienna, Austria, on December 6th. The presenter will be study principal investigator, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine.
AstraZeneca PLC (NYSE: AZN) recently announced Study Results Show SYMBICORT Improves Lung Function in Pediatric Asthma PatientsResults from the international, multicenter ChildHood Asthma Safety and Efficacy (CHASE) 3 Phase III study showed that SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol 80/4.5 micrograms significantly improved lung function in pediatric patients between 6 to <12 years of age with asthma versus budesonide 80 micrograms, demonstrating its appropriateness as step-up therapy in this patient population.
Gilead Sciences, Inc. (NASDAQ: GILD) recently announced top-line results from two Phase 3 clinical trials (SIMPLIFY 1 and 2) evaluating momelotinib, an investigational inhibitor of Janus kinase (JAK) compared to ruxolitinib or best alternative therapy (BAT) in patients with myelofibrosis. The SIMPLIFY-1 study achieved its pre-specified primary endpoint of non-inferiority to ruxolitinib for splenic response rate at Week 24 (SRR24), defined as the percentage of patients experiencing a ? 35 percent reduction in spleen volume (momelotinib: 26.5%; ruxolitinib: 29.0%; 95 percent CI: -11.2% to +5.6%; p=0.011)
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