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BEERSE, Belgium--(BUSINESS WIRE)--Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for DARZALEX®▼ (daratumumab).1 If approved by the European Commission, daratumumab can be used in combination with lenalidomide and dexamethasone; or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.1 Despite the incredible work of the oncology community over the past decade, MM remains an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.2 The Positive Opinion of the CHMP was based on a review of data from the Phase 3 MMY3003 (POLLUX) study, published in The New England Journal of Medicine in October 2016,3 and the Phase 3 MMY3004 (CASTOR) study, also published in The New England Journal of Medicine in August 2016.4 The safety profile of daratumumab in combination with standard-of-care regimens was consistent with monotherapy studies. In combination with lenalidomide, and dexamethasone (POLLUX) the most common adverse events of grade 3 or 4 during treatment were neutropenia (51.9%), thrombocytopenia (12.7%), and anaemia (12.4%).3 Daratumumab-associated infusion-related reactions occurred in 47.7% of the patients and were mostly of grade 1 or 2.3 In combination with bortezomib and dexamethasone (CASTOR) three of the most common grade 3 or 4 adverse events reported were thrombocytopenia (45.3%), anaemia (14.4%), and neutropenia (12.8%).4 Infusion-related reactions that were associated with daratumumab treatment were reported in 45.3% of the patients; these reactions were mostly grade 1 or 2 (grade 3 in 8.6% of patients), and in 98.2% of these patients, they occurred during the first infusion.4 “This Positive Opinion recognises progress in the treatment of multiple myeloma and has the potential to offer new treatment options to eligible patients.” said Torben Plesner, M.D., Vejle Hospital, Vejle, Denmark, a daratumumab clinical trial investigator. “Daratumumab has already demonstrated single-agent efficacy in highly refractory patients. Now, consistent with these data, the results when used in combination with standard-of-care regimens after one prior line of therapy are also encouraging.” Daratumumab first received conditional approval from the European Commission (EC) in May 2016, indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.5,6 Daratumumab was the first CD38-directed monoclonal antibody approved for use worldwide. “Almost all patients with multiple myeloma have to endure relapses which typically become more aggressive,” said Dr Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, the Middle East and Africa (EMEA). “I am heartened by this important and rapid recommendation which recognises the progress in multiple myeloma treatment.” The CHMP’s Positive Opinion will now be reviewed by the European Commission, which has the authority to grant approval of the new indication. This milestone follows last year’s decision by the U.S. Food and Drug Administration (FDA) on 21 November 2016, to approve the expanded use of daratumumab in combination with bortezomib/dexamethasone or lenalidomide/dexamethasone in patients with multiple myeloma who have received at least 1 prior therapy.7 Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.2 MM is the second most common form of blood cancer, with around 39,000 new cases worldwide in 2012.8 MM most commonly affects people over the age of 65 and is more common in men than in women.9 The most recent five-year survival data for 2000-2007 show that across Europe, up to half of newly diagnosed patients do not reach five-year survival.10 Almost 29% of patients with MM will die within one year of diagnosis.11 Although treatment may result in remission, unfortunately, patients will most likely relapse as there is currently no cure. While some patients with MM have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.9 Patients who relapse after treatment with standard therapies, including PIs and immunomodulatory agents, have poor prognoses and few treatment options available.12 Daratumumab is a first-in-class biologic targeting CD38, a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.13-15 Daratumumab induces rapid tumour cell death through apoptosis (programmed cell death)6,16 and multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).6,17,18 Daratumumab has also demonstrated immunomodulatory effects that contribute to tumour cell death via a decrease in immune suppressive cells including T-regs, B-regs and myeloid-derived suppressor cells.6,19 Daratumumab is being evaluated in a comprehensive clinical development programme that includes five Phase 3 studies across a range of treatment settings in multiple myeloma. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases in which CD38 is expressed. For more information, please see www.clinicaltrials.gov. For further information on daratumumab, please see the Summary of Product Characteristics at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004077/human_med_001979.jsp&mid=WC0b01ac058001d124. In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement, which granted Janssen an exclusive license to develop, manufacture and commercialise daratumumab. At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea. Follow us at www.twitter.com/janssenEMEA. This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding the potential benefits of, and expanded indication for, DARZALEX® (daratumumab). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the uncertainties inherent in product development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1. EMA. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000378.jsp. Last accessed February 2017. 2. American Society of Clinical Oncology. Multiple myeloma: overview. Available at: http://www.cancer.net/cancer-types/multiple-myeloma/overview Last accessed November 2016. 3. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide and dexamethasone for multiple myeloma. New Eng J Med. 2016;375:1319–1331. 4. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib and dexamethasone for relapsed and refractory multiple myeloma. New Eng J Med. 2016;375:754–766. 5. Janssen. Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM). Available at: http://www.janssen.com/janssen-s-single-agent-darzalex-daratumumab-approved-european-commission-treatment-multiple-myeloma. Last accessed November 2016. 6. European Medicines Agency. DARZALEX summary of product characteristics, May 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004077/WC500207296.pdf Last accessed August 2016. 7. DARZALEX® Prescribing Information November 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761036s004lbl.pdf. Last accessed January 2016. 8. GLOBOCAN 2012. Multiple myeloma. Available at: http://globocan.iarc.fr/old/burden.asp?selection_pop=62968&Textp=Europe&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=13&type=0&window=1&submit=%C2%A0Execute Last accessed November 2016. 9. American Cancer Society. Multiple myeloma: detailed guide. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf. Last accessed November 2016. 10. De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68. 12. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57. 13. Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm. 2013;2013:564687. 14. Lin P, Owens R, Tricot G, et al. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8. 15. Santoconito AM, Consoli U, Bagnato S et al. Flow cytometric detection of aneuploid CD38++ plasmacells and CD19+ B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in multiple myeloma patients. Leuk Res. 2004;28:469-77. 16. Overdijk MB, Jansen JH, Nederend M, et al. The Therapeutic CD38 Monoclonal Antibody Daratumumab Induces Programmed Cell Death via Fcy Receptor-Mediated Cross-Linking. J Immunol. 2016;197(3):807-13. 17. de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011;186:1840-8. 18. Overdijk MB, Verploegen S, Bögels M, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7:311-21. 19. Krejcik J, Casneuf T, Nijhof IS, et al. Daratumumab depletes CD38+ immune-regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016;128:384-94.


News Article | February 15, 2017
Site: globenewswire.com

Helsinn Provides Grant for ESMO's Preceptorship Course on Supportive and Palliative Care Lugano, Switzerland, February 15, 2017 - Helsinn, a Swiss pharmaceutical group focused on building quality cancer care, announces that the Group has provided a grant to the European Society for Medical Oncology ("ESMO") for a preceptorship event dedicated to supportive and palliative care for physicians. The preceptorship course will take place in Zurich on February 20-21, 2017 and will touch on a broad range of aspects related to cancer supportive and palliative care. The key learning objectives of the preceptorship are to: The Chair of the event will be Dr Florian Strasser MD, Associate Professor in the Clinic Oncology/Hematology at the Cantonal Hospital St. Gallen, Head of Oncological Palliative Medicine at Cantonal Hospital St Gallen, Switzerland, where he is responsible for the clinical and research activities in Palliative Oncology and in Geriatric Oncology. He is also substantially involved in Geriatric Oncology, Supportive Care and Cancer Rehabilitation for both in- and out-patients in the Comprehensive Cancer Center. The co-Chair is Dr Karin Jordan who, since 2010, has been Associate Professor of Medical Oncology and Supportive Care in the Department of Oncology/Haematology at the University Hospital, Halle, and who has just recently changed position and is now working at the University of Heidelberg. The event is expected to be attended by members of ESMO from around the world. The aim of these educational courses, which focus on teaching standard of care in specific areas, is to provide "state of the art" lectures in an interactive setting including formal presentations and interaction between experts and attendees presenting clinical cases. The full meeting program is available here. Sergio Cantoreggi, Helsinn Group Chief Scientific Officer, said: "At Helsinn we are delighted to be able to provide a grant to ESMO to work with physicians and further advance supportive and palliative care through this Preceptorship Course. This event will help foster relationships between senior, experienced physicians, and those at the start of their careers, meaning that patients will receive the best possible supportive care to help them live with cancer on a day to day basis." Dr Florian Strasser MD, Chair of the Preceptorship Course on Supportive and Palliative Care, commented: "I am delighted this event dedicated to both supportive and palliative care has been organized, and I thank those at Helsinn for their generous and fully unrestricted support in helping us establish this. Supportive and palliative care is an area of oncology that does not receive enough merit increasing attention in modern, personalized oncology and this event will help to address this problem." Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a broad development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Ireland and the US, a representative office in China as well as a product presence in about 90 countries globally. For more information, please visit www.helsinn.com. ESMO is the leading professional organisation for medical oncology. With 15,000 members representing oncology professionals from over 130 countries worldwide, ESMO is the society of reference for oncology education and information. We are committed to supporting our members to develop and advance in a fast-evolving professional environment.


Die positive Beurteilung des CHMP basierte auf einer Prüfung der Daten aus der „Phase-3-Studie MMY3003“ (POLLUX), die im Oktober 2016 im The New England Journal of Medicine veröffentlicht wurde,3 sowie aus der Studie „Phase-3-Studie MMY3004“ (CASTOR), im August 2016 ebenfalls im The New England Journal of Medicine veröffentlicht.4 Das Sicherheitsprofil von Daratumumab in Kombination mit Standardbehandlungsmethoden stimmte mit Montotherapiestudien überein. Bei Verabreichung von Lenalidomid in Verbindung mit Dexamethason (POLLUX) traten bei der Behandlung als häufigste Nebenwirkungen von Grad 3 oder 4 Neutropenie (51,9 %), Thrombozytopenie (12,7 %) und Anämie (12,4 %) auf.3 Die Zugabe von Daratumumab führte bei 47,7 % der Patienten zu infusionsbedingten Reaktionen, meist von Grad 1 oder 2.3 In Kombination mit Bortezomib und Dexamethason (CASTOR) wurden als die drei häufigsten Nebenwirkungen von Grad 3 oder 4 Thrombozytopenie (45,3 %), Anämie (14,4 %) und Neutropenie (12,8 %) beobachtet.4 Bei 45,3 % der Patienten zeigten sich infusionsbedingte Reaktionen infolge der Behandlung mit Daratumumab. Diese Reaktionen waren überwiegend von Grad 1 oder 2 (Grad 3 bei 8,6 % der Patienten), und bei 98,2 % der Behandelten traten die Reaktionen während der ersten Infusion auf.4 „Nahezu alle Patienten mit multiplem Myelom erleiden Rückfälle, die in der Regel immer aggressiver werden“, erläuterte Dr. Catherine Taylor, Haematology Therapeutic Area Lead, Janssen Europe, the Middle East and Africa (EMEA). „Diese wichtige und schnelle Empfehlung ermutigt mich, denn sie würdigt die Fortschritte in der Behandlung des multiplen Myeloms.“ 1. EMA. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 February 2017. Verfügbar unter: http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000378.jsp. Zuletzt aufgerufen Februar 2017. 2. American Society of Clinical Oncology. Multiple myeloma: overview. Available at: http://www.cancer.net/cancer-types/multiple-myeloma/overview Zuletzt aufgerufen November 2016. 3. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide and dexamethasone for multiple myeloma. New Eng J Med. 2016;375:1319–1331. 4. Palumbo A, Chanan-Khan A, Weisel K, et al. Daratumumab, bortezomib and dexamethasone for relapsed and refractory multiple myeloma. New Eng J Med. 2016;375:754–766. 5. Janssen. Janssen’s Single-Agent DARZALEX® (daratumumab) Approved by European Commission for Treatment of Multiple Myeloma (MM). Verfügbar unter: http://www.janssen.com/janssen-s-single-agent-darzalex-daratumumab-approved-european-commission-treatment-multiple-myeloma. Zuletzt aufgerufen November 2016. 10. De Angelis R, Minicozzi P, Sant M, et al. Survival variations by country and age for lymphoid and myeloid malignancies in Europe 2000-2007: results of EUROCARE-5 population-based study. Eur J Cancer. 2015;51:2254-68. 12. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26:149-57. 13. Fedele G, di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNgamma cytokines and proliferation. Mediat Inflamm. 2013;2013:564687. 14. Lin P, Owens R, Tricot G, et al. Flow cytometric immunophenotypic analysis of 306 cases of multiple myeloma. Am J Clin Pathol. 2004;121:482-8. 15. Santoconito AM, Consoli U, Bagnato S et al. Flow cytometric detection of aneuploid CD38++ plasmacells and CD19+ B-lymphocytes in bone marrow, peripheral blood and PBSC harvest in multiple myeloma patients. Leuk Res. 2004;28:469-77. 16. Overdijk MB, Jansen JH, Nederend M, et al. The Therapeutic CD38 Monoclonal Antibody Daratumumab Induces Programmed Cell Death via Fcy Receptor-Mediated Cross-Linking. J Immunol. 2016;197(3):807-13. 17. de Weers M, Tai YT, van der Veer MS, et al. Daratumumab, a novel therapeutic human CD38 monoclonal antibody, induces killing of multiple myeloma and other hematological tumors. J Immunol. 2011;186:1840-8. 18. Overdijk MB, Verploegen S, Bögels M, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7:311-21. 19. Krejcik J, Casneuf T, Nijhof IS, et al. Daratumumab depletes CD38+ immune-regulatory cells, promotes T-cell expansion, and skews T-cell repertoire in multiple myeloma. Blood. 2016;128:384-94.


NEW YORK, Feb. 21, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of clinical data from a Phase 1/2 trial of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) previously exposed to rituximab. The data demonstrates single agent TG-1101 to be well tolerated with the most common adverse event observed being grade 1/2 infusion related reactions (IRR), with no grade 3/4 IRRs.  TG-1101 monotherapy was active, with a 45% overall response rate (ORR) observed among heavily pretreated patients with NHL and CLL, including those who were refractory to prior anti-CD20 based therapy.  These data are described further in the manuscript titled, “A phase 1/2 trial of ublituximab, a novel, glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab,” which was published online today in the British Journal of Haematology. The online version of the article can be accessed at http://onlinelibrary.wiley.com/doi/10.1111/bjh.14534/full. “We want to thank Dr. Owen O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their work on this Phase 1/2 trial of single agent TG-1101 and congratulate them on the publication of these data.  Since the inception of our Company, we have been focused on developing best-in-class agents with the goal of building novel combination therapies.  This single agent data illustrates that TG-1101 is a safe and highly-active anti-CD20 monoclonal antibody on top of which additional treatments can be layered.  The safety profile, speed of infusion, and response rates observed, with single agent TG-1101, especially in rituximab-refractory patients, serve as a foundation for our belief that TG-1101 is a best-in-class anti-CD20 monoclonal antibody,” stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics.  Mr. Weiss continued, “These Phase 1/2 data, as well as the combination data of TG-1101 plus ibrutinib published in the British Journal of Haematology late last year, further support our Phase 3 GENUINE trial of TG-1101 in combination with ibrutinib and we look forward to presenting top-line data from this study in the first half of this year.” “The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL.  Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and believe the drug’s safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients,” stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Some of the statements included in this press release, particularly those with respect to anticipating the timing of the completion of the GENUINE study, timing of top-line data for the GENUINE study, the usability of the results from GENUINE for accelerated approval, timing of initial data from the UNITY-DLBCL study, timing of the release of data and commencement of our MS pivotal program may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the GENUINE, the UNITY-CLL or the UNITY-DLBCL trials; the risk that the clinical results from the GENUINE, UNITY-CLL and/or UNITY-DLBCL studies will be not positive and/or will not support regulatory approval of TG-1101 or TGR-1202; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk that we will not file a BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk that despite early positive trends in enrollment in the UNITY-CLL study that enrollment will be delayed beyond our projections; the risk that the planned interim analysis will not allow early closure of the single agent arms in the UNITY-CLL study, necessitating enrollment beyond the projected 450 patients, which would extend enrollment beyond our projections; the risk that safety issues or trends will be observed in the GENUINE study, the UNITY-CLL and/or the UNITY-DLBCL study that prevent approval of either TG-1101 and/or TGR-1202 or require us to terminate either the GENUINE study or the UNITY-CLL or the UNITY-DLBCL study prior to completion; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that the GENUINE study, as amended or the UNITY-CLL or the UNITY-DLBCL studies, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory approval; the risk that trials will take longer to enroll than expected; the risk that the projected cost savings to be realized by amending the GENUINE trial will not be realized; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


NEW YORK, Feb. 21, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of clinical data from a Phase 1/2 trial of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) previously exposed to rituximab. The data demonstrates single agent TG-1101 to be well tolerated with the most common adverse event observed being grade 1/2 infusion related reactions (IRR), with no grade 3/4 IRRs.  TG-1101 monotherapy was active, with a 45% overall response rate (ORR) observed among heavily pretreated patients with NHL and CLL, including those who were refractory to prior anti-CD20 based therapy.  These data are described further in the manuscript titled, “A phase 1/2 trial of ublituximab, a novel, glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab,” which was published online today in the British Journal of Haematology. The online version of the article can be accessed at http://onlinelibrary.wiley.com/doi/10.1111/bjh.14534/full. “We want to thank Dr. Owen O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their work on this Phase 1/2 trial of single agent TG-1101 and congratulate them on the publication of these data.  Since the inception of our Company, we have been focused on developing best-in-class agents with the goal of building novel combination therapies.  This single agent data illustrates that TG-1101 is a safe and highly-active anti-CD20 monoclonal antibody on top of which additional treatments can be layered.  The safety profile, speed of infusion, and response rates observed, with single agent TG-1101, especially in rituximab-refractory patients, serve as a foundation for our belief that TG-1101 is a best-in-class anti-CD20 monoclonal antibody,” stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics.  Mr. Weiss continued, “These Phase 1/2 data, as well as the combination data of TG-1101 plus ibrutinib published in the British Journal of Haematology late last year, further support our Phase 3 GENUINE trial of TG-1101 in combination with ibrutinib and we look forward to presenting top-line data from this study in the first half of this year.” “The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL.  Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and believe the drug’s safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients,” stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Some of the statements included in this press release, particularly those with respect to anticipating the timing of the completion of the GENUINE study, timing of top-line data for the GENUINE study, the usability of the results from GENUINE for accelerated approval, timing of initial data from the UNITY-DLBCL study, timing of the release of data and commencement of our MS pivotal program may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the GENUINE, the UNITY-CLL or the UNITY-DLBCL trials; the risk that the clinical results from the GENUINE, UNITY-CLL and/or UNITY-DLBCL studies will be not positive and/or will not support regulatory approval of TG-1101 or TGR-1202; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk that we will not file a BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk that despite early positive trends in enrollment in the UNITY-CLL study that enrollment will be delayed beyond our projections; the risk that the planned interim analysis will not allow early closure of the single agent arms in the UNITY-CLL study, necessitating enrollment beyond the projected 450 patients, which would extend enrollment beyond our projections; the risk that safety issues or trends will be observed in the GENUINE study, the UNITY-CLL and/or the UNITY-DLBCL study that prevent approval of either TG-1101 and/or TGR-1202 or require us to terminate either the GENUINE study or the UNITY-CLL or the UNITY-DLBCL study prior to completion; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that the GENUINE study, as amended or the UNITY-CLL or the UNITY-DLBCL studies, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory approval; the risk that trials will take longer to enroll than expected; the risk that the projected cost savings to be realized by amending the GENUINE trial will not be realized; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


NEW YORK, Feb. 21, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of clinical data from a Phase 1/2 trial of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) previously exposed to rituximab. The data demonstrates single agent TG-1101 to be well tolerated with the most common adverse event observed being grade 1/2 infusion related reactions (IRR), with no grade 3/4 IRRs.  TG-1101 monotherapy was active, with a 45% overall response rate (ORR) observed among heavily pretreated patients with NHL and CLL, including those who were refractory to prior anti-CD20 based therapy.  These data are described further in the manuscript titled, “A phase 1/2 trial of ublituximab, a novel, glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab,” which was published online today in the British Journal of Haematology. The online version of the article can be accessed at http://onlinelibrary.wiley.com/doi/10.1111/bjh.14534/full. “We want to thank Dr. Owen O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their work on this Phase 1/2 trial of single agent TG-1101 and congratulate them on the publication of these data.  Since the inception of our Company, we have been focused on developing best-in-class agents with the goal of building novel combination therapies.  This single agent data illustrates that TG-1101 is a safe and highly-active anti-CD20 monoclonal antibody on top of which additional treatments can be layered.  The safety profile, speed of infusion, and response rates observed, with single agent TG-1101, especially in rituximab-refractory patients, serve as a foundation for our belief that TG-1101 is a best-in-class anti-CD20 monoclonal antibody,” stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics.  Mr. Weiss continued, “These Phase 1/2 data, as well as the combination data of TG-1101 plus ibrutinib published in the British Journal of Haematology late last year, further support our Phase 3 GENUINE trial of TG-1101 in combination with ibrutinib and we look forward to presenting top-line data from this study in the first half of this year.” “The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL.  Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and believe the drug’s safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients,” stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Some of the statements included in this press release, particularly those with respect to anticipating the timing of the completion of the GENUINE study, timing of top-line data for the GENUINE study, the usability of the results from GENUINE for accelerated approval, timing of initial data from the UNITY-DLBCL study, timing of the release of data and commencement of our MS pivotal program may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the GENUINE, the UNITY-CLL or the UNITY-DLBCL trials; the risk that the clinical results from the GENUINE, UNITY-CLL and/or UNITY-DLBCL studies will be not positive and/or will not support regulatory approval of TG-1101 or TGR-1202; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk that we will not file a BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk that despite early positive trends in enrollment in the UNITY-CLL study that enrollment will be delayed beyond our projections; the risk that the planned interim analysis will not allow early closure of the single agent arms in the UNITY-CLL study, necessitating enrollment beyond the projected 450 patients, which would extend enrollment beyond our projections; the risk that safety issues or trends will be observed in the GENUINE study, the UNITY-CLL and/or the UNITY-DLBCL study that prevent approval of either TG-1101 and/or TGR-1202 or require us to terminate either the GENUINE study or the UNITY-CLL or the UNITY-DLBCL study prior to completion; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that the GENUINE study, as amended or the UNITY-CLL or the UNITY-DLBCL studies, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory approval; the risk that trials will take longer to enroll than expected; the risk that the projected cost savings to be realized by amending the GENUINE trial will not be realized; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


NEW YORK, Feb. 21, 2017 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of clinical data from a Phase 1/2 trial of TG-1101 (ublituximab), the Company's novel glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) previously exposed to rituximab. The data demonstrates single agent TG-1101 to be well tolerated with the most common adverse event observed being grade 1/2 infusion related reactions (IRR), with no grade 3/4 IRRs.  TG-1101 monotherapy was active, with a 45% overall response rate (ORR) observed among heavily pretreated patients with NHL and CLL, including those who were refractory to prior anti-CD20 based therapy.  These data are described further in the manuscript titled, “A phase 1/2 trial of ublituximab, a novel, glycoengineered anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab,” which was published online today in the British Journal of Haematology. The online version of the article can be accessed at http://onlinelibrary.wiley.com/doi/10.1111/bjh.14534/full. “We want to thank Dr. Owen O’Connor, and the team from Columbia Presbyterian Medical Center and the Center for Lymphoid Malignancies for their work on this Phase 1/2 trial of single agent TG-1101 and congratulate them on the publication of these data.  Since the inception of our Company, we have been focused on developing best-in-class agents with the goal of building novel combination therapies.  This single agent data illustrates that TG-1101 is a safe and highly-active anti-CD20 monoclonal antibody on top of which additional treatments can be layered.  The safety profile, speed of infusion, and response rates observed, with single agent TG-1101, especially in rituximab-refractory patients, serve as a foundation for our belief that TG-1101 is a best-in-class anti-CD20 monoclonal antibody,” stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics.  Mr. Weiss continued, “These Phase 1/2 data, as well as the combination data of TG-1101 plus ibrutinib published in the British Journal of Haematology late last year, further support our Phase 3 GENUINE trial of TG-1101 in combination with ibrutinib and we look forward to presenting top-line data from this study in the first half of this year.” “The addition of an anti-CD20 monoclonal antibody to other treatments, whether chemo-based or novel targeted therapies, has demonstrated to be an impactful way to enhance responses for patients with NHL and CLL.  Acquired resistance to rituximab is a significant clinical issue for which many patients need an alternative effective agent to overcome the resistance. We are highly encouraged by the results we have seen in the clinic with ublituximab and believe the drug’s safety profile, as well as shortened infusion times as compared to other anti-CD20s, can provide meaningful benefit to patients,” stated Dr. Owen A. O’Connor, Professor of Medicine and Experimental Therapeutics, Director Lymphoid Malignancies at Columbia Presbyterian Medical Center. TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies, with TG-1101 recently entering clinical development for autoimmune disorders. The Company also has pre-clinical programs to develop IRAK4 inhibitors, BET inhibitors, and anti-PD-L1 and anti-GITR antibodies. TG Therapeutics is headquartered in New York City. Some of the statements included in this press release, particularly those with respect to anticipating the timing of the completion of the GENUINE study, timing of top-line data for the GENUINE study, the usability of the results from GENUINE for accelerated approval, timing of initial data from the UNITY-DLBCL study, timing of the release of data and commencement of our MS pivotal program may be forward-looking statements that involve a number of risks and uncertainties.  For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.  Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete the GENUINE, the UNITY-CLL or the UNITY-DLBCL trials; the risk that the clinical results from the GENUINE, UNITY-CLL and/or UNITY-DLBCL studies will be not positive and/or will not support regulatory approval of TG-1101 or TGR-1202; the risk that the FDA will not grant us a pre-BLA meeting to discuss the results of the GENUINE study; the risk that we will not file a BLA for TG-1101 or an NDA for TGR-1202 based on either the GENUINE or the UNITY-CLL; the risk that despite early positive trends in enrollment in the UNITY-CLL study that enrollment will be delayed beyond our projections; the risk that the planned interim analysis will not allow early closure of the single agent arms in the UNITY-CLL study, necessitating enrollment beyond the projected 450 patients, which would extend enrollment beyond our projections; the risk that safety issues or trends will be observed in the GENUINE study, the UNITY-CLL and/or the UNITY-DLBCL study that prevent approval of either TG-1101 and/or TGR-1202 or require us to terminate either the GENUINE study or the UNITY-CLL or the UNITY-DLBCL study prior to completion; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that the GENUINE study, as amended or the UNITY-CLL or the UNITY-DLBCL studies, or any of our other registration-directed clinical trials as designed or amended may not be sufficient or acceptable to support regulatory approval; the risk that trials will take longer to enroll than expected; the risk that the projected cost savings to be realized by amending the GENUINE trial will not be realized; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.


News Article | February 23, 2017
Site: www.eurekalert.org

During its 43rd Annual Meeting in Marseille, France, from 26th-29th March, the EBMT will hold a series of activities for its 5,000 delegates to celebrate 60 years of medical innovations saving patients' lives. The EBMT celebrates 60 years of medical innovations saving the lives of patients with blood cancers and other deadly diseases During its 43rd Annual Meeting in Marseille, France, from 26th-29th March, the EBMT will hold a series of activities for its 5,000 delegates to celebrate 60 years of medical innovations saving patients' lives. The EBMT will acknowledge the work that stems from the pioneering observations made by E. Donnall Thomas, also known as the father of bone marrow transplantation and who received the Nobel Prize in Medicine in 1990. For over 60 years Thomas' colleagues and fellows, not only in the United States but also in Europe and worldwide, have worked relentlessly in preclinical and clinical research to develop innovative treatments that improve the outcome and quality of life for cancer patients. This year marks the 60th anniversary of one of the seminal publications that triggered the introduction of haematopoietic stem cell transplantation (HSCT) in medical practices worldwide. This landmark paper by Thomas et al. entitled, "Intravenous infusion of bone marrow in patients receiving radiation and chemotherapy" was published in the New England Journal on the 12th September 1957. The same year, this group also published other landmark papers in Blood. From the mid-1950s, Thomas developed methods for providing people with new bone marrow cells through transplants. Using radiation, chemotherapy, and nowadays immunosuppressive drugs, the body's own bone marrow cells are killed and the immune system's rejection mechanism is subdued. Bone marrow cells from a donor are then provided through a blood transfusion. In 1958, a year after Thomas' paper, Georges Mathé performed the first ever successful allogeneic bone marrow transplant on unrelated human beings. Since then, major developments in the field of HSCT have occurred thanks to the contributions of researchers worldwide. In fact, Nobel Prizes in physiology or medicine have been awarded for research in stem cells and transplantation: Jean Dausset, Baruj Benacerraf and Georges D. Snell in 1980 for the HLA histocompatibility system discovery; Joseph E. Murray and E. Donnall Thomas in 1990 for their discoveries concerning organ and cell transplantation for the treatment of human disease. The "EBMT's mission is very important and very ambitious," states Mohamad Mohty, President of the EBMT, and Head of the Haematology department at the Saint-Antoine Hospital in Paris. "Our goal is to conquer and cure blood diseases. In 1974, the visionary founders of the EBMT created one of the most successful medical societies in the world, and established a transplant registry that 43 years later includes 500,000 registered patients. The EBMT is in the privileged position of being always in the lead to disseminate knowledge, and advance the field of stem cell transplantation and cellular therapy" concludes Professor Mohty. While research is evolving, all eyes are turned towards novel cellular therapies for potential applications. Christian Chabannon, President of the 43rd EBMT Annual Meeting and Secretary of the Cellular Therapy and Immunobiology Working Party explains: "This denotes significant changes in the field, where medical practices evolve from the relatively monotypic approach of haematopoietic cell transplant to the more versatile use of different categories of cellular therapies." The EBMT's objective is to understand and exploit the biological, including immunological, events occurring upon HSCT at large, and to implement modern cellular therapies based on cell and gene engineering approaches to improve transplantation outcomes. At the Opening Session of the 43rd EBMT Annual Meeting, Rainer Storb from the faculty of both, the Fred Hutchinson Cancer Research Center and the University of Washington School of Medicine, will give a keynote lecture entitled, "60 years of HSCT: progress from bone marrow transplantation to the first cellular and gene therapies." The EBMT is a not-for-profit medical and scientific organisation established in 1974. It is dedicated to fighting life-threatening blood cancers and diseases and improving patients' lives. The EBMT Members--more than 4,000 physicians, nurses, scientists and other healthcare professionals--participate in a unique collaborative network of peers involved in HSCT and cellular therapy research. The membership encompasses more than 600 centres, from over 60 countries, that perform or are involved in HSCT. The EBMT holds a central role in performing co-operative studies and disseminating state-of-the-art knowledge aimed at increasing survival rates and enhancing the quality of life of patients with life-threatening blood cancers and diseases. For further information about the EBMT, please visit the website: http://www. and follow us on Twitter: @TheEBMT


In a talk focused on novel therapeutic strategies to prevent relapse, the most important cause of treatment failure after hematopoietic stem cell transplant (HSCT) in patients with hematologic malignancies, Sergio Giralt, MD, Chief of the Adult Bone Marrow Transplantation at Sloan Kettering, highlighted Actinium Pharmaceuticals' Iomab-B. The renowned physician was optimistic about the potential of adding targeted agents to the pretransplant conditioning regimen to increase the antitumor effect. Of these options, Dr. Giralt focused extensively on Actinium's lead product candidate, Iomab-B, a radiolabeled antibody-drug conjugate targeted against CD45; and rituximab, an antibody directed against CD20. Actinium's Iomab-B is a therapy designed to help prepare patients for a hematopoietic stem cell transplant. Actinium is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML), age 55 and older. Internationally recognized, Dr. Giralt is board certified in internal medicine with subspecialties in medical oncology and hematology. He is an active member of the American Medical Association, American College of Physicians, American Society of Hematology, American Society of Clinical Oncology, North American Society of Blood and Bone Marrow Transplantation (ASBMT), International Society of Hematotherapy and Graft Engineering, International Society of Haematology, and the Gerontological Society of America. Actinium, a company founded on technology developed by MSK, continues to work closely with the world-renowned cancer center, a relationship that has only been enhanced since the company in-licensed Iomab-B. Sergio Giralt, MD, along with other leading physicians at Sloan Kettering, currently serves on the Advisory Board of Actinium Pharmaceuticals. For more information on Iomab-B and the other therapeutic candidates in Actinium's robust product pipeline visit: http://www.actiniumpharma.com/ Online Media Group, Inc. is not registered with any financial or securities regulatory authority and does not provide, nor claims to provide, investment advice or recommendations to readers of this release to buy, sell or hold any securities. Investing intrinsically involves substantial risk and readers are reminded to consult an investment professional and complete their own due diligence, including SEC filings, when researching any companies mentioned in this release. This release is based upon publicly available information and, while vetted, is not considered to be all-inclusive or guaranteed to be free from errors. With respect to Section 17(B) of the Securities Act of 1933 and in the interest of full disclosure, we call the reader's attention to the fact that Online Media Group, Inc. may have received compensation from the companies mentioned in this release.


The strong collaboration between Actinium Pharmaceuticals and the prestigious Memorial Sloan Kettering Cancer Center (MSK) was on full display during a recent presentation at a satellite symposium to the 2017 BMT Tandem Meetings (http://www.onclive.com/conference-coverage/bmt-tandem-2017/novel-pretransplant-conditioning-regimens-seek-to-reduce-relapse-in-blood-cancers). In a talk focused on novel therapeutic strategies to prevent relapse, the most important cause of treatment failure after hematopoietic stem cell transplant (HSCT) in patients with hematologic malignancies, Sergio Giralt, MD, Chief of the Adult Bone Marrow Transplantation at Sloan Kettering, highlighted Actinium Pharmaceuticals' Iomab-B. The renowned physician was optimistic about the potential of adding targeted agents to the pretransplant conditioning regimen to increase the antitumor effect. Of these options, Dr. Giralt focused extensively on Actinium's lead product candidate, Iomab-B, a radiolabeled antibody-drug conjugate targeted against CD45; and rituximab, an antibody directed against CD20. Actinium's Iomab-B is a therapy designed to help prepare patients for a hematopoietic stem cell transplant. Actinium is currently conducting a single pivotal 150-patient, multicenter Phase 3 clinical study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML), age 55 and older. Internationally recognized, Dr. Giralt is board certified in internal medicine with subspecialties in medical oncology and hematology. He is an active member of the American Medical Association, American College of Physicians, American Society of Hematology, American Society of Clinical Oncology, North American Society of Blood and Bone Marrow Transplantation (ASBMT), International Society of Hematotherapy and Graft Engineering, International Society of Haematology, and the Gerontological Society of America. Actinium, a company founded on technology developed by MSK, continues to work closely with the world-renowned cancer center, a relationship that has only been enhanced since the company in-licensed Iomab-B. Sergio Giralt, MD, along with other leading physicians at Sloan Kettering, currently serves on the Advisory Board of Actinium Pharmaceuticals. For more information on Iomab-B and the other therapeutic candidates in Actinium's robust product pipeline visit: http://www.actiniumpharma.com/ Online Media Group, Inc. is not registered with any financial or securities regulatory authority and does not provide, nor claims to provide, investment advice or recommendations to readers of this release to buy, sell or hold any securities. Investing intrinsically involves substantial risk and readers are reminded to consult an investment professional and complete their own due diligence, including SEC filings, when researching any companies mentioned in this release. This release is based upon publicly available information and, while vetted, is not considered to be all-inclusive or guaranteed to be free from errors. With respect to Section 17(B) of the Securities Act of 1933 and in the interest of full disclosure, we call the reader's attention to the fact that Online Media Group, Inc. may have received compensation from the companies mentioned in this release.

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