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CTI BioPharma Announces Presentations at the American Association of Cancer Research Annual Meeting

On April 13, 2016 CTI BioPharma Corp. (CTI) (NASDAQ and MTA:CTIC) reported that data highlighting pacritinib, pixantrone and tosedostat will be presented at the upcoming American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 16-20 in New Orleans, LA (Press release, CTI BioPharma, APR 12, 2016, View Source;p=RssLanding&cat=news&id=2156655 [SID:1234510734]). The abstracts are available on the AACR (Free AACR Whitepaper) website at www.aacr.org.

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Poster Presentations

Pacritinib

Combinatorial strategies for glioblastoma using brain tumor-initiating cells: targeting the JAK/STAT and EGFR pathways
First Author: Hema Luchman, Ph.D., Hotchkiss Brain Institute, University of Calgary, Calgary, AB
Date/Time: Sunday, April 17 at 1:00 p.m.-5:00 p.m. ET
Location: Section 15
Poster Session: Combinatorial Strategies
Abstract #279 / Poster Board #20

The nonclinical toxicology profile of pacritinib, a JAK2/FLT3 inhibitor with no dose-limiting clinical myelosuppression
First Author: Rebecca Watson, CTI BioPharma Corp., Seattle, WA
Date/Time: Monday, April 18 at 1:00 p.m.-5:00 p.m. ET
Location: Section 37
Poster Session: Targets, Markers, and Agents in Cancer Prevention
Abstract #2602 / Poster Board #2

Pacritinib reduces human myeloid leukemia stem cell maintenance in a defined niche
First Author: Larissa Balaian, Ph.D., Moores Cancer Center, University of California, San Diego, CA
Date/Time: Tuesday, April 19 at 8:00 a.m.-12:00 p.m. ET
Location: Section 32
Poster Session: Stemness Properties of Leukemias and Carcinomas
Abstract #3338 / Poster Board #6

Investigation of absorption, metabolism, excretion, and mass balance of [14C]-pacritinib in healthy subjects: a phase 1 study
First Author: Suliman Al-Fayoumi, CTI BioPharma Corp., Seattle, WA
Date/Time: Wednesday, April 20 at 8:00 a.m.-12:00 p.m. ET
Location: Section 13
Poster Session: Phase 1 Clinical Trials 2
Abstract #CT159 / Poster Board #20

Synergistic effect of pacritinib with erlotinib on JAK2-mediated resistance in epidermal growth factor receptor mutation-positive non-small cell lung cancer
First Author: Nobuaki Ochi, M.D., Ph.D., Kawasaki Medical School, Okayama, Japan
Date/Time: Wednesday, April 20 at 8:00 a.m.-12:00 p.m. ET
Location: Section 15
Poster Session: Combination Therapies and Approaches to Sensitizing Cancer Cells to Drugs
Abstract #4675 / Poster Board #16

Pixantrone

Combinations containing the aza-anthracenedione pixantrone show preclinical activity in diffuse large B-cell lymphoma (DLBCL)
First Author: Chiara Tarantelli, Ph.D., IOR Institute of Oncology Research, Bellinzona, Switzerland
Date/Time: Wednesday, April 20 at 8:00 a.m.-12:00 p.m. ET
Location: Section 19
Poster Session: Novel Chemotherapies
Abstract #4793 / Poster Board #18

Tosedostat

Enhancing the efficacy of tosedostat through carboxylesterase induction
First Author: Priscilla Wei Ling Hong, Ph.D., The University of Queensland Diamantina Institute, Brisbane, Australia
Date/Time: Wednesday, April 20 at 8:00 a.m.-12:00 p.m. ET
Location: Section 20
Poster Session: Targeted Therapy
Abstract #4806 / Poster Board #1

About Pacritinib

Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis including, but not limited to, patients with disease-related thrombocytopenia (low platelet counts); patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy; or patients who are intolerant of, or whose symptoms are not well controlled (sub-optimally managed) on other JAK2 therapy. Clinical studies for pacritinib are currently subject to a full clinical hold issued by the U.S. Food and Drug Administration in February 2016.

CTI BioPharma and Baxalta Incorporated are parties to a worldwide license agreement to develop and commercialize pacritinib. CTI BioPharma and Baxalta will jointly commercialize pacritinib in the U.S. while Baxalta has exclusive commercialization rights for all indications outside the U.S.

About PIXUVRI (pixantrone)

PIXUVRI is a novel aza-anthracenedione with unique structural and physiochemical properties. PIXUVRI was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite — both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity.

In May 2012, the European Commission granted conditional marketing authorization for PIXUVRI as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of PIXUVRI treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy. The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.pixuvri.eu. PIXUVRI does not have marketing approval in the United States.

About Tosedostat

Tosedostat is an investigational oral aminopeptidase inhibitor that has demonstrated anti-tumor responses in blood-related cancers and solid tumors in Phase 1-2 clinical trials. Tosedostat is currently being evaluated in multiple Phase 2 clinical trials for the treatment of patients with AML or high-risk MDS. Tosedostat is not approved or commercially available.

The assessment of HER2 status in breast cancer: the past, the present, and the future.

Humanized monoclonal anti-human growth factor receptor 2 (HER2) antibody trastuzumab was approved for HER2 positive breast cancer patient treatment 11 years after the demonstration of HER2 gene amplification associated with the HER2 protein overexpression in breast cancer in 1987. HER2 positive status of breast cancer patients is assessed by HER2 gene amplification with in situ hybridization (ISH) and/or HER2 protein overexpression with immunohistochemistry (IHC). Because the discordance between quantitative HER2 ISH and subjective, semi-quantitative HER2 IHC assay results is a well-recognized issue of HER2 testing, we developed an assay combining HER2 ISH and HER2 IHC assays (HER2 gene-protein assay; HER2 GPA) as one test on the same tissue section. HER2 GPA allows pathologists to score the HER2 gene and HER2 protein status simultaneously at the individual cell level. The possibility that HER2 GPA may become the next generation of HER2 testing is discussed, particularly for cases in which it is difficult to assess the HER2 status of breast cancer patients due to the HER2 heterogeneity.
© 2016 The Authors. Pathology International published by Japanese Society of Pathology and John Wiley &amp; Sons Australia, Ltd.

Complications of Cytoreductive Surgery and HIPEC in the Treatment of Peritoneal Metastases.

The combined treatment concept of cytoreductive surgery (CRS) and Hyperthermic intraperitoneal chemotherapy (HIPEC) has shown to be an efficient therapeutic option for selected patients with primary and secondary peritoneal carcinomatosis (PC). This strategy represents the standard of care for diseases like pseudomyxoma peritonei and peritoneal mesothelioma, and offers the best long-term results for PC from colorectal cancer. Despite these results, skepticism exists regarding this therapeutic approach partly because of its perceived high toxicity. In this article, we review the current evidence on complications that can occur after CRS and HIPEC and the risk factors associated with increased incidence of morbidity and mortality.

Cytoreductive Surgery and Peritonectomy Procedures.

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) has become widely accepted as an effective method of treating peritoneal metastases (PM) from various cancers. CRS performed with the goal of removing all the macroscopic disease and comprises of peritonectomy procedures and visceral resections. CRS is a technically challenging surgery that requires a considerable amount of skill and appropriate patient selection. This article is a review of the techniques and current recommendations for performing CRS.

Peritoneal Metastases: Prevention and Treatment.

Colorectal cancer is a surgicaly curable disease. It requires multimodality of treatment in Localy advanced and metastatic disease. Molecular markers like RAS mutation has brought in change in the mangement of metastatic disease. Nearly 15 to 20 % presents with peritonieal surface metastasis. The debate continues with systomic vs Cyutoreductive surgery with are without HIPEC. This article highlights management of peritoneal metastasis with special reference to prevention and treatment.