Biotechs and the Advancements in Cancer Oriented Clinical Trials

Friday, September 30, 2016 Cancer News
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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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