NEW YORK, September 30, 2016 /PRNewswire/ --
An important step in discovering new treatments for cancer and
any sort of disease, as well as new ways to identify, analyze, and
decrease the risk of disease, is by performing clinical trials.
This shows researchers the many approaches we are capable of and
while revealing the possible side effects of treatments.
Actinium Pharmaceuticals Inc. (NYSEMKT: ATNM),
Kite Pharma Inc. (NASDAQ: KITE), Ariad
Pharmaceuticals, Inc. (NASDAQ: ARIA), Puma
Biotechnology Inc. (NYSE: PBYI), Juno Therapeutics
Inc. (NASDAQ: JUNO).
Actinium Pharmaceuticals Inc. (NYSEMKT: ATNM) made
headlines after the recent announcement of commencing Phase II
clinical trials of the company's most advanced alpha particle
immunotherapy, Actimab-A, in patients above the age of 60 who were
newly diagnosed with Acute Myeloid Leukemia (AML). The Actimab-A
alpha particle immunotherapy program consists of the CD33 (a
protein on AML cells) targeting monoclonal antibody (HuM195) and
the actinium-225, a promising therapeutic radionuclide to
target alpha therapy of cancer and infectious diseases.
Actinium's Phase II clinical trial consists of 53 patients who
will be given Actimab-A in a low dose (2.0
µCi/kilogram/fractionated) of its Actimab-A through two injections
given on the first and seventh day of treatment. The objective of
Phase II is to determine if Lintuzumab-225 and cytarabine, a
standard chemotherapy drug, can regulate AML and also the safety of
this drug combination. Lintuzumab is a monoclonal antibody that
targets CD33 and Ac-225 is a radioactive substance. The Phase II
trial is designed to gauge complete response rates at up to day 42
after Actimab-A administration while determining the antileukemic
effects, including its ability to produce complete remissions, of
Lintuzumab-Ac225.
Actinium Pharmaceuticals Inc. (ATNM) has decided
to incorporate peripheral blast burden as an inclusion criteria and
in patients with high peripheral blast burden, the use of
Hydroxyurea will be directed with the aim of bringing peripheral
blast burden below a key threshold number that the Company has
performed from two previously finished Phase 1 clinical trials
consisting of 38 patients. Furthermore, will mandate the use of
granulocyte colony-stimulating factors. Low dose cytarabine has
been removed from the procedure and the Phase 2 clinical trial will
assess Actimab-A as a monotherapy. Overall survival will be its
secondary endpoint of Phase II clinical trials.
Actinium Pharmaceuticals Inc. (ATNM) Executive
Chairman, Sandesh Seth stated, "We
are excited to have initiated the Phase 2 trial of Actimab-A for
elderly patients who are newly diagnosed with AML and ineligible
for 7+3 treatment. These older patients face a poor prognosis and
have limited viable treatment options. We are encouraged by the
safety and efficacy signals we have seen thus far and look forward
to the execution of this trial with an eye toward interim and
top-line results which are both expected in 2017."
Clinical-stage biopharmaceutical company, Kite Pharma
Inc. (NASDAQ: KITE) recently announced their latest
results from a pre-planned interim analysis ZUMA-1 (Phase II
clinical trial) of the company's most advanced candidate, KTE-C19,
had met its primary endpoint objective. KTE-C19 revealed that 76
percent of patients that has Non-Hodgkin Lymphoma, a cancer that
starts in cells called lymphocytes that are part of the body's
immune system, responded firmly to the treatment, including 47
percent complete remissions.
Ariad Pharmaceuticals, Inc. (NASDAQ: ARIA) has
publicized its partnership with Otsuka Pharmaceutical, along with
regulatory approval for its prescription medication,
Iclusig®(ponatinib) from Japanese Pharmaceuticals and
Medical Devices Agency. Iclusig is used for the treatment of
chronic myeloid leukemia resistant or intolerant to preceding drug
treatment and relapsed or treatment resistant Philadelphia chromosome-positive acute
lymphoblastic leukemia.
U.S. Food and Drug Administration has approved Puma
Biotechnology Inc. (NYSE: PBYI) new drug application,
PB272 (Neratinib), for extended adjuvant treatment of HER2-positive
early stage breast cancer. Neratinib allows the company to treat
patients with overexpressed breast cancer who have also had prior
adjuvant breast cancer therapy with Herceptin (trastuzumab). Puma
Biotechnology is a biopharmaceutical company devoted to the
acquisition and development of novel therapeutics for the treatment
of cancer.
Researchers from the Fred Hutchinson Cancer Research center
shared data results from patients with advanced non-Hodgkin
Lymphoma who received Chimeric Antigen Receptor T-Cell treatment
and chemotherapy, JCAR014. This was a key study for Juno
Therapeutics Inc. (NASDAQ: JUNO) in order to further
develop its similar product candidate for the treatment of CD19
positive blood cancers, JCAR017. Patients received intermediate
doses of JCAR014 had an overall response rate of 82 percent (9/11),
thus showing promising early effectiveness of the treatment.
Complete response rate was 64 percent (7/11), Severe Cytokine
Release Syndrome was 9 percent, and Severe Neurotoxicity was 18
percent (2/11).
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