On September 27, 2018 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), reported that the European Patent Office ("EPO") has issued European Patent No. EP2940014B1 for CG-806, a first-in-class, highly potent oral small molecule being developed for acute myeloid leukemia (AML), B cell and other hematologic malignancies (Press release, Aptose Biosciences, SEP 27, 2018, View Source [SID1234529656]). The granted patent claims various compounds, including the CG-806 compound, pharmaceutical compositions comprising the CG-806 compound, and uses for the treatment of various diseases, such as cancer. This European patent will be nationalized in, and cover, approximately forty European countries including the United Kingdom, France, Germany, Italy, Netherlands and Spain. The patent is expected to provide protection until the end of 2033.

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"This is a meaningful decision by the EPO and adds to the previously issued patents in the US and Japan for CG-806," stated Dr. William G. Rice, Chairman, President and Chief Executive Officer of Aptose. "We will continue to strengthen the patent portfolio through additional findings and applications."

About CG-806

CG-806 is an oral, first-in-class pan-FLT3/pan-BTK multi-kinase inhibitor. This small molecule demonstrates potent inhibition of wild type and mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates acute myeloid leukemia (AML) tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with AML. Likewise, CG-806 demonstrates potent, non-covalent inhibition of the wild type and Cys481Ser mutant forms of the BTK enzyme, as well as other oncogenic kinase pathways operative in B cell malignancies, suggesting CG-806 may be developed for various B cell malignancy patients (including CLL, MCL, DLBCL and others) that are resistant/refractory/intolerant to covalent BTK inhibitors.

About CrystalGenomics

CrystalGenomics, Inc. is a commercial stage biopharmaceutical company focused in the structure-based drug discovery and development of novel therapeutics in unmet medical need areas of inflammation, oncology, and infectious disease. In addition to several drug programs in the R&D pipeline, the Company has an osteoarthritis drug on the market and, has recently added manufacturing and commercialization capabilities through multiple acquisitions. For more information, please visit: www.cgxinc.com or www.crystalgenomics.com. CrystalGenomics, Inc. is listed on KOSDAQ (083790).

On September 27, 2018 INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported that Saeed Motahari, president and chief executive officer, and Andy Long, chief financial officer, will present at the upcoming 2018 Cantor Global Healthcare Conference as follows (Press release, Insys Therapeutics, SEP 27, 2018, View Source [SID1234529647]):

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Date: Tuesday, Oct. 2, 2018
Time: 1:05 p.m. Eastern Time
Location: New York, N.Y.
The presentation will be webcast live at the aforementioned time, and archived for 90 days thereafter, via the Investors section of company’s website at View Source, under Presentations & Events. Accessible at the same webpage, the presentation slides will be available during and after the conference.

On September 27, 2018 CytoSen Therapeutics, a private biopharmaceutical company accelerating innovation in Natural Killer (NK) cell therapy, reported it has received a favorable response from the U.S. Food and Drug Administration ("FDA") to its pre-Investigational New Drug ("pre-IND") meeting package for the proposed Phase 2 trial of CytoSen’s adoptive NK cell therapy, CSTD002-NK, for the reduction of relapse in high risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in patients undergoing haploidentical hematopoietic stem cell transplantation (HSCT) (Press release, CytoSen Therapeutics, SEP 27, 2018, View Source [SID1234529634]). The FDA agreed that the Company’s pre-clinical studies, in combination with results from the clinical trial conducted at The University of Texas MD Anderson Cancer Center adequately support the Company’s proposed Phase 2 clinical trial. The FDA also deemed the proposed dose regimen, safety assessment and study endpoints as appropriate, and confirmed that interim results from the clinical study could be considered for a Regenerative Medicine Advanced Therapy (RMAT) designation.

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"We are pleased with the feedback and clarification we received from the FDA, which reinforces our clinical development strategy and serves as a critical next step to initiate our planned AML-transplant study," said Trent Carrier, Ph.D., CEO of CytoSen. "We look forward to commencing the trial in the first half of 2019."

CSTD002-NK is a high dose, adoptive haploidentical NK cell therapy expanded ex vivo using CytoSen’s patented nanoparticle platform. The proposed Phase 2 trial is CytoSen’s first clinical study utilizing the nanoparticle technology, which produces highly activated NK cells within a scalable manufacturing platform.

About CytoSen’s NK Cell Platform

Natural Killer cells play a significant role in the body’s innate immune response, circulating through the body to rapidly recognize and kill cancerous cells. CytoSen’s nanoparticle processing technology enables improved and sustained growth of high-dose NK cells that have potent anti-cancer cytotoxicity as well as increased expansion and activation capabilities. CytoSen’s lead clinical product, CSTD002-NK, is poised to initiate Phase 2 trial enrollment in the U.S. in the first half of 2019 as a best-in-class NK cell therapy for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) in HSCT patients.

CytoSen’s technology platform is based on the work of Dean Lee, M.D., Ph.D., Co-Founder of CytoSen and Chair of CytoSen’s Scientific Advisory Board and Director of the Cellular Therapy and Cancer Immunotherapy Program for Nationwide Children’s Hospital’s Division of Hematology/Oncology/BMT and Center for Childhood Cancer and Blood Diseases, and Stefan Ciurea, M.D., Associate Professor, Department of Stem Cell Transplantation, MD Anderson Cancer Center. Data from Phase I/II clinical trials at MD Anderson demonstrated compelling results in treating AML, providing validation for CytoSen’s strategic clinical development program.

On September 27, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported that Bonnie H. Anderson, chairman and chief executive officer, will present at the 2018 Cantor Fitzgerald Global Healthcare Conference on Tuesday, October 2, 2018, at 1:05 p.m. Eastern Time (ET) (Press release, Veracyte, SEP 27, 2018, View Source [SID1234529633]).

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A live audio webcast of the presentation will be available by visiting Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On September 27, 2018 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it has successfully completed a study to determine the best assay method for the accurate determination of the number of viable encapsulated cells at any given time inside PharmaCyte’s Cell-in-a Box capsules, which will be used for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, SEP 27, 2018, View Source [SID1234529632]).

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The decision on which viability assay to use is an important component required for the filing of PharmaCyte’s Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA), since the viable cell assay is needed to show how many living cells are in the capsules at any given moment. This is a parameter that influences the biological activity of PharmaCyte’s Cell-in-a-Box encapsulated cell product.

This particular study compared three different methods for determining the number of viable cells in the capsules as well as the growth rate of the cells within the capsules. Although the rate of growth has already been fixed as part of the production process (and is not affected by this study), the new data revealed that only one of the tested methods can accurately estimate the number of cells within a capsule, particularly when the capsules are populated at high cell densities as they will be for use in PharmaCyte’s clinical trial in patients with LAPC. Therefore, this study provides the justification for the use of the most accurate and sensitive assay chosen by this study, which will also be used for quality control of the product release for the upcoming planned clinical trial for LAPC.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained the significance of the study saying, "The cells that are encapsulated using the Cell-in-a-Box technology are the engine for the final product in that they activate the chemotherapeutic agent ifosfamide at the site of the tumor in the pancreatic cancer patient. This study is important since it shows we now have at our disposal the best method to determine the actual number of living cells in the capsules.

"The data from this study is another key piece of information required for PharmaCyte to comply with FDA guidelines and recommendations for our planned, upcoming clinical trial in patients with LAPC. This viability information must be reliable; therefore, it is also valuable for ensuring good quality control of our final product. In other words, using the chosen viability measuring method will help us ensure that the Cell-in-a-Box encapsulated product is reproducible from batch to batch. This is an essential requirement for any medicinal product."