On April 20, 2017 Atossa Genetics, Inc. (NASDAQ: ATOS), a clinical-stage pharmaceutical company, reported that it has received a positive interim review on its Phase 1 study of endoxifen, which is an active metabolite of the FDA approved drug tamoxifen, which is indicated for breast cancer and breast cancer prevention in high risk patients (Press release, Atossa Genetics, APR 20, 2017, View Source [SID1234518655]). The Independent Safety Committee reviewed the blinded data generated from the first cohort of the study (8 subjects) and concluded that the study may advance to the next dosing level. Schedule your 30 min Free 1stOncology Demo! "This positive safety determination is on the critical path for our Phase 1 study," stated Steven Quay, CEO and President. "It is the first assessment of our clinical safety and tolerability data and it indicates that proceeding to the next dosing level with our proprietary topical Endoxifen is warranted. We can now advance to the next level of the study which is to escalate the dosage in a new cohort of subjects as we continue to monitor safety and tolerability in the first cohort of the study."
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The objectives of this double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects is to assess the pharmacokinetics of proprietary formulations of both oral and topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted in two parts based on route of administration.
The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.
Month: April 2017
H3 Biomedicine Extends Collaboration with Foundation Medicine to Develop Precision Therapies for Cancer
On April 20, 2017 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of Eisai’s global Oncology Business Group, reported that is has extended its multi-year collaboration with Foundation Medicine, Inc. for the discovery and development of precision medicines in oncology, which was signed in February 2015 (http:/bit.ly/2plSOPS) (Press release, H3 Biomedicine, APR 20, 2017, View Source [SID1234518654]). Schedule your 30 min Free 1stOncology Demo! H3 and Foundation Medicine will continue to build upon the progress the two companies have made during the collaboration. The companies will collaborate to interrogate the FoundationCORETM dataset, with the goal of expanding the translation of ongoing H3 programs and identifying new, actionable cancer drivers.
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"Having access, through Foundation Medicine, to a high quality, large scale data set for identification of novel driver events and clinical translation helps create a competitive edge for H3 within the current oncology drug development market," said Markus Warmuth, M.D., President and Chief Executive Officer of H3 Biomedicine. "The collaboration with Foundation Medicine has broadened the scope of our clinical programs and has pointed us in new, unique directions and we look forward to continuing this successful collaboration."
"The genomics data in FoundationCORE is a better reflection of patients seeking treatment in current clinical practice compared with publically available data sets, and it will continue to evolve as new therapies are adopted," said Lihua Yu, Vice President of Data Science and IT at H3 Biomedicine. "Thorough computational analysis beyond variant calls allows us to connect genomic aberrations with disease context which can directly impact the trajectory of our pipeline."
ZIOPHARM Oncology to Present Updated Clinical Results of Gene Therapy Candidate Ad-RTS-hIL-12 + Veledimex in Recurrent Glioblastoma at the 2017 ASCO Annual Meeting
On April 20, 2017 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, reported that it will present updated results from its Phase 1, multicenter, dose-escalation study of Ad-RTS-hIL-12 + orally administered veledimex in patients with recurrent or progressive glioblastoma at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 2-6 in Chicago (Press release, Ziopharm, APR 20, 2017, View Source [SID1234518653]). Ad-RTS-hIL-12 + veledimex is a novel, viral gene therapy candidate for the controlled expression of interleukin-12 (IL-12), a pro-inflammatory cytokine critical for stimulating anti-cancer immune responses. Schedule your 30 min Free 1stOncology Demo! Details for the poster presentation at ASCO (Free ASCO Whitepaper) 2017:
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Title: Expanded phase I study of intratumoral Ad-RTS-hIL-12 plus oral veledimex: Tolerability and survival in recurrent glioblastoma
Abstract Number: 2044
Session: Central Nervous System Tumors
Date and Time: Monday, June 5, 2017, 1:15 — 4:45 p.m. CT
TG Therapeutics, Inc. Announces Clinical Data Presentations at the Upcoming 53rd Annual Meeting of the American Society of Clinical Oncology
On April 20, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that clinical abstracts featuring TG-1101 and TGR-1202 have been selected for presentation at the upcoming 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 2 – 6, 2017, at McCormick Place in Chicago, Illinois (Press release, TG Therapeutics, APR 20, 2017, View Source [SID1234518652]). Details of the data presentations are outlined below. Schedule your 30 min Free 1stOncology Demo! Oral Presentation:
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Title: Ublituximab and ibrutinib for previously treated genetically high-risk chronic lymphocytic leukemia: Results of the GENUINE Phase 3 study
Abstract Number: 7504
Presentation Date & Time: Saturday, June 3, 2017 3:00 PM – 6:00 PM CT
Session Title: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Jeffrey P. Sharman, MD
Poster Discussion Presentation:
Title: Tolerability and activity of chemo-free triplet combination of TGR-1202, ublituximab, and ibrutinib in patients with advanced CLL and NHL
Abstract Number: 7511
Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT (Poster Viewing); 1:15 PM-2:30 PM CT (Poster Discussion)
Session Title: Poster Discussion Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Loretta Nastoupil, MD
Trials in Progress Poster Presentation:
Title: KI intolerance study: A phase 2 study to assess the safety and efficacy of TGR-1202 in pts with chronic lymphocytic leukemia (CLL) who are intolerant to prior BTK or PI3K-delta inhibitor therapy
Abstract Number: TPS7569
Presentation Date & Time: Monday, June 5, 2017 8:00 AM-11:30 AM CT
Session Title: Poster Session, Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Presenter: Colleen Dorsey, BSN, RN
The above abstracts will be released publicly on May 17, 2017 through the ASCO (Free ASCO Whitepaper) meeting website at www.asco.org. Following each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com.
RedHill Biopharma Announces Peer-Reviewed Publication of the Positive YELIVA® Phase I Study Results in Advanced Solid Tumors
On April 20, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported the publication of an article describing the positive results from the Phase I clinical study with YELIVA (ABC294640)1 in advanced solid tumors (Press release, RedHill Biopharma, APR 20, 2017, View Source [SID1234518651]). Schedule your 30 min Free 1stOncology Demo! The article2, entitled "A Phase I Study of ABC294640, a First-in-Class Sphingosine Kinase-2 Inhibitor, in Patients with Advanced Solid Tumors", was authored by scientists from the Medical University of South Carolina (MUSC) Hollings Cancer Center and Apogee Biotechnology and was published in Clinical Cancer Research. The article is available online on the journal’s website3.
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YELIVA is a Phase II-stage, proprietary, first-in-class, orally-administered sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities, targeting multiple oncology, inflammatory and gastrointestinal indications. By inhibiting the SK2 enzyme, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid signaling molecule that promotes cancer growth and pathological inflammation.
The open-label, dose-escalation, pharmacokinetic (PK) and pharmacodynamic (PD) first-in-human Phase I study with YELIVA treated 21 patients with advanced solid tumors, most of whom were gastrointestinal cancer patients, including pancreatic, colorectal and cholangiocarcinoma cancers. The Phase I study was conducted at the MUSC Hollings Cancer Center and led by Principal Investigators Melanie Thomas, MD, and Carolyn Britten, MD.
The primary objectives of the study were to identify the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) and to evaluate the safety of YELIVA. The secondary objectives of the study were to determine the pharmacokinetic (PK) and pharmacodynamic (PD) properties of YELIVA and to assess its antitumor activity.
Final results from the Phase I study with YELIVA in patients with advanced solid tumors confirmed that the study successfully met its primary and secondary endpoints, demonstrating that the drug is well-tolerated and can be safely administered to cancer patients. There was one partial response in a patient with cholangiocarcinoma and six patients had stable disease as their best response.
The study included the first-ever longitudinal analyses of plasma S1P levels as a potential PD biomarker for activity of a sphingolipid-targeted drug. The administration of YELIVA resulted in a rapid and pronounced decrease in S1P levels over the first 12 hours, with return to baseline at 24 hours, which is consistent with clearance of the drug.
A Phase II study with YELIVA for the treatment of advanced hepatocellular carcinoma (HCC) is ongoing at MUSC Hollings Cancer Center. The study is supported by a grant from the NCI, awarded to MUSC, which is intended to fund a broad range of studies on the feasibility of targeting sphingolipid metabolism for the treatment of a variety of solid tumor cancers, with additional support from RedHill.
A Phase Ib/II study with YELIVA for the treatment of refractory or relapsed multiple myeloma is ongoing at Duke University Medical Center. The study is supported by a $2 million grant from the NCI Small Business Innovation Research Program (SBIR) awarded to Apogee, in conjunction with Duke University, with additional support from RedHill.
A Phase I/II clinical study evaluating YELIVA in patients with refractory/relapsed diffuse large B-cell lymphoma and Kaposi sarcoma patients is ongoing at the Louisiana State University Health Sciences Center. The study is supported by a grant from the NCI awarded to Apogee, with additional support from RedHill.
A Phase Ib study to evaluate YELIVA as a radioprotectant for prevention of mucositis in head and neck cancer patients undergoing therapeutic radiotherapy is planned to be initiated in the third quarter of 2017.
YELIVA recently received FDA Orphan Drug designation for the treatment of cholangiocarcinoma. RedHill plans to initiate a Phase IIa clinical study with YELIVA in patients with advanced, unresectable, intrahepatic and extrahepatic cholangiocarcinoma in the third quarter of 2017.
A Phase II study to evaluate the efficacy of YELIVA in patients with moderate to severe ulcerative colitis is planned to be initiated in the second half of 2017.
About YELIVA (ABC294640):
YELIVA (ABC294640) is a Phase II-stage, proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor with anticancer and anti-inflammatory activities. RedHill is pursuing with YELIVA multiple clinical programs in oncology, inflammatory and gastrointestinal indications. By inhibiting SK2, YELIVA blocks the synthesis of sphingosine 1-phosphate (S1P), a lipid-signaling molecule that promotes cancer growth and pathological inflammation. SK2 is an innovative molecular target for anticancer therapy because of its critical role in catalyzing the formation of S1P, which is known to regulate cell proliferation and activation of inflammatory pathways. YELIVA was originally developed by U.S.-based Apogee Biotechnology Corp. and completed multiple successful pre-clinical studies in oncology, inflammation, GI and radioprotection models, as well as the ABC-101 Phase I clinical study in cancer patients with advanced solid tumors. The Phase I study included the first-ever longitudinal analysis of plasma S1P levels as a potential pharmacodynamic (PD) biomarker for activity of a sphingolipid-targeted drug. The administration of YELIVA resulted in a rapid and pronounced decrease in S1P levels, with several patients having prolonged stabilization of disease. YELIVA received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma. The development of YELIVA was funded to date primarily by grants and contracts from U.S. federal and state government agencies awarded to Apogee Biotechnology Corp., including the U.S. National Cancer Institute, the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Defense and the FDA Office of Orphan Products Development.