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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