Pentostatin

The US Centers for Medicare and Medicaid Services (CMS) has quietly updated the list of Part B prescription medicines subject to penalties because their prices rose faster than the rate of inflation. In an update late last week, the agency cut seven medicines from its original list of 27 that was unveiled on March 15.A provision in the Inflation Reduction Act (IRA), which came into force last year, penalises pharmaceutical companies for charging prices that go up faster than inflation for people with disabilities or those 65 and older who are on the government's Medicare health programme (for more, see ViewPoints: Inflation Reduction Act's myriad impacts to reverberate across pharma). The move is expected to lower out-of-pocket costs for some Medicare recipients by between $1 and $372 per average dose, as of April 1, depending on their individual coverage, according to an agency press release updated on March 30.Gilead cell therapies knocked off The seven drugs that have been cut from the original list include Gilead Sciences' CAR-T therapies Yescarta (axicabtagene ciloleucel) and Tecartus (brexucabtagene autoleucel); Stemline Therapeutics' Elzonris (tagraxofusp-erzs) used for blastic plasmacytoid dendritic cell neoplasm; Shionogi's Fetroja (cefiderocol), an antibiotic to treat complicated urinary tract infections; Arcotech Biopharma's Folotyn (pralatrexate) for relapsed or refractory peripheral T-cell lymphoma; Kamada's WinRho SDF (Rhₒ(D) immune globulin) to boost platelet counts in order to prevent excessive haemorrhage; and Bausch + Lomb's Xipere (triamcinolone acetonide), which is prescribed for macular oedema associated with uveitis.CMS did not give a reason for why the original list was scaled back. Other products that remain include all five Pfizer drugs that were on the original list, namely Atgam (antithymocyte globulin equine), Bicillin L-A (penicillin G benzathine), Bicillin C-R (penicillin G benzathine and penicillin G procaine), Fragmin (dalteparin) and Nipent (pentostatin), as well as Johnson & Johnson's Rybrevant (amivantamab). Companies whose products have been flagged will be required to pay Medicare the difference in the form of a rebate ranging from roughly 14% to 20%. Meanwhile, CMS has said that by September 1, it plans to publish the first 10 Medicare Part D drugs that will be subject to government price negotiations starting in 2026. 

CARLSBAD, Calif., Aug. 18, 2022 (GLOBE NEWSWIRE) -- Qualigen Therapeutics, Inc. (Nasdaq: QLGN), a diversified life sciences company focused on developing treatments for adult and pediatric cancers with potential for Orphan Drug Designation, while also commercializing diagnostics, today announces it has formed a Scientific Advisory Board (SAB) in support of the development of its lead therapeutic candidate QN-302 for the potential treatment of pancreatic cancer and other G4-prevalent solid tumors. “We have assembled a distinguished and diverse group of scientific oncology experts from leading research institutions and industry groups worldwide to guide Qualigen Therapeutics through a rigorous and expeditious path to develop QN-302 for pancreatic cancer, and possibly other important indications. The formation of this SAB demonstrates our strong belief in the potential of QN-302, and we are confident that the vast experience of its members will help advance the program,” commented Michael Poirier, Qualigen’s Chairman and CEO. Members of the QN-302 Scientific Advisory Board include: Patricia LoRusso, D.O., Professor of Medicine, Medical Oncology and Associate Cancer Center Director, Experimental Therapeutics, Yale School of Medicine Dr. LoRusso brings more than 25 years of expertise in medical oncology, drug development, and early phase clinical trials. Prior to her Yale appointment as Professor of Medicine (Medical Oncology), she served in numerous leadership roles at Wayne State University’s Barbara Karmanos Cancer Institute, most recently as director of the Phase I Clinical Trials Program and of the Eisenberg Center for Experimental Therapeutics. Dr. LoRusso is the recipient of numerous prestigious awards including most recently, the Joseph H. Burchenal Award for Outstanding Achievement in Clinical Cancer Research presented to her by the American Association for Cancer Research in April 2022. Dr. LoRusso has also been involved in many service disciplines at the National Cancer Institute. She has served on the Investigational Drug Steering Committee (IDSC) since inception (2005-present) and served as its chair from 2011-2013. She was a member of the steering committee that convened after the Blue-Ribbon Panel to execute on their recommendations. She served a 4-year term (2015-2019) on the Board of Scientific Council (BSC), reviewing the intramural programs for quality, content, productivity, and funding. Dr. LoRusso has served in leadership positions of several other organizations. She has served on the Board of Directors and numerous scientific and education committees of the American Association for Cancer Research (AACR), the education and scientific committees of the American Society of Clinical Oncology (ASCO), and the steering committee for the Food and Drug Administration (FDA) Accelerating Anticancer Agent Development and Validation Workshop, as examples. Lillian Siu, M.D., Senior Scientist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada, and Professor of Medicine,University of Toronto Dr. Lillian Siu is a senior medical oncologist at Princess Margaret Cancer Centre and a Professor of Medicine at the University of Toronto. She directs the Phase I Program and is the clinical leader for the Tumor Immunotherapy Program at the Princess Margaret Cancer Centre. She holds the BMO (Bank of Montreal) hair in Precision Genomics (2016-2026). Dr. Siu is the Co-Contact Principal Investigator of the North American Star Consortium UM1 Phase I Grant as part of the U.S. National Cancer Institute Experimental Therapeutics Clinical Trials Network. Dr. Siu has served on the Board of Directors for both ASCO and AACR. Dr. Siu was the recipient of the U.S. National Cancer Institute Michaele C. Christian Award in Oncology Drug Development in 2010; and also the recipient of the 2022 ESMO Targeted Anticancer Therapies Honorary Award. Dr. Siu is the inaugural co-editor-in-chief of AACR’s new journal Cancer Research Communications. She is also on the Editorial Boards for Cell and Cancer Cell. Michael Gordon, M.D., Chief Medical Officer, HonorHealth Research Institute, Scottsdale, Ariz. and Clinical Professor of Medicine, University of Arizona College of Medicine. Dr. Gordon is a medical oncologist with a special interest in sarcoma and phase I investigational drug development. His career has focused on translational cancer therapy trials, and he has led efforts in cutaneous oncology both at Indiana University as well as at the HonorHealth Research Institute, which is currently focused on the Arizona Rare Cancer Initiative. The organization is investing significant effort in the strategy for developing treatments for uveal melanoma and rare sarcomas including translational studies as well as pre-clinical models. Dr. Gordon is the former President and CEO of Pinnacle Oncology Hematology in Scottsdale, AZ, and is currently Chief Medical Officer at the HonorHealth Research Institute in Scottsdale, AZ, Clinical Professor of Medicine at the University of Arizona College of Medicine in Phoenix and Clinical Professor at the Translational Genomics Research Institute in Phoenix. Dr Gordon was instrumental in the clinical development of antiangiogenic agents for the treatment of cancer and more recently, led the effort for the development of new immuno-oncology (I-O) therapies to treat cancer. Anthony Tolcher, M.D., Co-Founder, START and NEXT Oncology, San Antonio, Tex. Dr. Anthony Tolcher is a medical oncologist and co-founder of START and NEXT Oncology, both world-class clinical oncology sites dedicated to Phase 1 clinical trials in oncology. He is dedicated to the development of new anticancer agents — including clinical trials and therapies — for patients looking for their next option now that their current cancer therapy is no longer working to their benefit. Dr. Tolcher was a Fogarty Fellow at the National Institute of Health and received the Murray Muirhead Award for humanitarian and academic excellence and the Goel Prize in Medicine for excellence in the Clinical Disciplines. He is a Fellow of the Royal College of Physicians of Canada; a Diplomate of the American Board of Internal Medicine and Medical Oncology; and a member of the American College of Physicians, and the American Society of Clinical Oncologists. He also serves as a member of the American Society of Clinical Oncology Scientific Program Committee and the Cancer Education Committee. Christopher Slapak, M.D., Adjunct Clinical Associate Professor of Medicine, Indiana University School of Medicine and Pharmacology. Dr. Christopher Slapak has 25 years of broad pharmaceutical development experience. Dr. Slapak served as the Chief Medical Officer at Vor Biopharma from 2019 to 2022. He held executive positions for over 20 years at Eli Lilly and Company as Distinguished Lilly Scholar and also Vice President Early Phase Oncology Clinical Development. In that role, he oversaw the global clinical development of all early-stage oncology compounds for Lilly and Imclone. Dr. Slapak consults on scientific and medical aspects of hematology and oncology drug development. Areas of focus include pre-clinical data packages to support clinical development, implementation of first-in-human studies, and proof-of-concept designs in targeted patient populations. Prior consulting clients included Prelude Therapeutics (where Dr. Slapak served as their consultant CMO), Takeda Oncology, and Translational Drug Development (TD2). He is board certified in internal medicine, medical oncology and hematology and currently has a joint appointment as Clinical Associate Professor of Medicine and Pharmacology at the Indiana University School of Medicine. Stephen Neidle, Ph.D., Professor Emeritus, University College London School of Pharmacy Professor Neidle and his team at the UCL School of Pharmacy originated and developed Qualigen’s QN-302 program. He has extensive experience in the discovery and development of anti-cancer and anti-infective drugs and has a distinguished and long history in nucleic acid research and drug design with over 500 published papers and 14 patents. He was educated at Imperial College London and was one of the first Cancer Research Campaign Career Development Awardees and subsequently a Life Fellow and Professorial Fellow of Cancer Research UK. His awards include the Sosnovsky and Aventis Prizes for work on the medicinal chemistry of cancer, the Interdisciplinary and Medicinal Chemistry Awards of the Royal Society of Chemistry, the Paul Ehrlich, Kelland and Guggenheim Lectureships, and a visiting Professorship at the University of Rome. He has held senior posts at The Institute of Cancer Research UK (Professor of Biophysics and Dean) and at the School of Pharmacy, University College London (Professor of Chemical Biology), where he is now an Emeritus Professor. Dr. Neidle was Founding Chair of the Royal Society of Chemistry Chemical Biology Forum and Chair of the Chemistry in Cancer Research Working Group, American Association for Cancer Research, 2011-12. He has been Editor-in-Chief of "Bioorganic and Medicinal Chemistry Letters” and is currently an editorial board member of it and the journals "Nucleic Acids Research," and "Methods". He chaired the “Annual Reports in Medicinal Chemistry" editorial board and was Chairman of the Editorial Boards of Tetrahedron Journals and the RSC Biomolecular Sciences book series. He has served on numerous grant panels nationally and internationally; including the Wellcome Trust and the Biotechnology and Biological Sciences Research Council (BBSRC) in the UK and was a member of the UK Blavatnik Awards Panel for Chemistry 2017-2019. Internationally he has chaired the Science Foundation of Ireland grants panels 2017, 2018, 2021, and chaired the Medical and Health Sciences Panel, Czech Academy of Sciences, 2020. Wayne Klohs, Ph.D., Chair of Scientific Advisory Board Dr. Klohs is an R&D executive and scientist with over thirty-five years of experience in the pharmaceutical industry. He is currently a consultant for over 10 biotechnology companies and serves on the Board of Directors and Scientific Advisory Boards for a number of biotechnology companies. During his distinguished career, Dr. Klohs served as acting head of Oncology Clinical Sciences at Takeda Global R&D, and Executive Director of Drug Development at Pfizer, Inc. At Takeda, he led both early and late-stage Development Teams in Oncology and was a member of Takeda’s Global Oncology Licensing Team. At Pfizer, he led development from mid-Discovery through proof of concept (POC) with additional experience in NDA filings including pentostatin/Nipent and suramin/Metaret. He led development teams to more than 14 successful IND filings and Phase 1 starts including a pan-erbB irreversible tyrosine kinase inhibitor, two MEK inhibitors for both oncology and inflammation, a cell cycle inhibitor, several P38 inhibitors, among others. Dr. Klohs served as a Senior Vice President and Global Therapeutic Area Head of Oncology for Astellas Pharmaceutical, Inc where he successfully filed NDAs and MAAs for Xtandi (enzalutamide) and Tarceva. He also led discovery efforts at Warner-Lambert/Parke Davis Pharmaceutical Research in oncology. AboutQualigenTherapeutics,Inc. Qualigen Therapeutics, Inc. is a diversified life sciences company focused on developing treatments for adult and pediatric cancer, as well as maintaining and expanding its core FDA-cleared FastPack® System, which has been used successfully in diagnostics for over 20 years. Our investigational QN-302 compound is a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells; such binding could, by stabilizing the G4s against “unwinding,” help inhibit cancer cell proliferation. Our investigational QN-247 compound inhibits nucleolin, a key multi-functional regulatory protein that is overexpressed in cancer cells; QN-247 may thereby be able to inhibit the cells’ proliferation. QN-247 has shown promise in preclinical studies for the treatment of acute myeloid leukemia (AML). The investigational compounds within Qualigen’s RAS-F family of RAS oncogene protein-protein interaction inhibitor small molecules are believed to inhibit or block the binding of mutated RAS genes’ proteins to their effector proteins, thereby leaving the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. In addition to its oncology drug pipeline, Qualigen has an established diagnostics business which manufactures and distributes proprietary and highly accurate rapid blood testing systems to physician offices and small hospitals for the management of prostate cancer and other diseases and health conditions. For more information about Qualigen Therapeutics, Inc., please visit . Forward-Looking Statements This news release contains forward-looking statements by Qualigen that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's prospects and strategy, including statements related to the development of QN-302 and the Company’s other therapeutic drug candidates. Actual events or results may differ from the Company's expectations. For example, here can be no assurance that the Company will be able to successfully develop any drugs (including QN-302, QN-247 and RAS-F); that preclinical development of the Company's drugs (including QN-302, QN-247 and RAS-F, and the deprioritized infectious-disease drug candidate QN-165) will be completed on any projected timeline or will be successful; that any clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline, or at all; that any future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs will receive required regulatory approvals (or Fast Track designation or Orphan Drug status) or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's currently owned and in-licensed patents would prevent competition; or that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products (including QN-302, QN-247 and RAS-F). The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business can be found in the Company's prior filings with the Securities and Exchange Commission, including its most recent Form 10-K, all of which are available at . The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Contact: Jules Abraham JQA Partners, Inc. 917-885-7378 jabraham@jqapartners.com Source: Qualigen Therapeutics, Inc.