TEL AVIV, Israel, Oct. 13, 2021 /PRNewswire/ --BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a pharmacoeconomic study evaluating the cost-effectiveness of using investigational drug Motixafortide as a primary stem cell mobilization (SCM) agent on top of granulocyte colony stimulating factor (G-CSF), versus G-CSF alone, in multiple myeloma patients undergoing autologous stem cell transplantation (ASCT). The study was performed by the Global Health Economics and Outcomes Research (HEOR) team of IQVIA, and was a pre-planned study conducted in parallel with the GENESIS Phase 3 trial. These results, together with the highly significant and clinically meaningful data from the GENESIS trial, strongly support the potential use of Motixafortide, on top of G-CSF, as the standard of care in SCM for ASCT.
The study concluded that the addition of Motixafortide to G-CSF (the current standard of care) is associated with a statistically significant decrease in health resource utilization (HRU) during the ASCT process, compared to G-CSF alone. Based on the significantly higher number of mobilized cells and the lower number of apheresis sessions, lifetime estimates show quality-adjusted-life-year (QALY) benefits and net cost savings of ~$17,000 (not including the cost of Motixafortide), versus G-CSF alone. The study findings, combined with model estimates, suggest that the use of Motixafortide, on top of G-CSF, as the standard of care in mobilization for ASCT, could be a cost-effective option in the US, based on accepted willingness-to-pay (WTP) values for healthcare payers.
"The compelling cost savings identified by this rigorously designed study strongly support the Company's view that Motixafortide, in combination with G-CSF, can become the new standard of care as an upfront, or primary, therapy for all multiple myeloma patients undergoing autologous stem cell transplantation," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Based on data from the GENESIS trial showing that nearly 90% of patients collected an optimal number of cells for transplantation following a single administration of Motixafortide and in only one apheresis session, versus less than 10% for G-CSF alone, the pharmacoeconomic study demonstrates that use of Motixafortide on top of G-CSF can save $17,000 per patient, not including the cost of Motixafortide. These cost savings should leave substantial room in the future to optimize our pricing strategy for Motixafortide at product launch and thereafter, if approved.
"It is also important to note that fewer administrations and apheresis sessions confer meaningful safety and time benefits to patients. In addition, the significantly higher median number of cells collected in one apheresis session ~11 million using Motixafortide on top of G-CSF versus ~2 million for G-CSF alone not only enables transplantation of an optimal number of cells, with the potential to significantly save on time to engraftment, it also permits the retention of enough cells for cryopreservation in the event that an additional transplantation is required in the future. Lastly, higher levels of certainty regarding the number of apheresis sessions required for mobilization could enable more efficient utilization of apheresis units at transplantation institutions, where there is often a shortage of available machines.
"We believe the data from the GENESIS study, together with the results from this pharmacoeconomic study, set Motixafortide apart from all other mobilization agents either currently available or in development. If approved, Motixafortide represents a significant advancement in SCM to the benefit of patients and payers alike, and, to that end, we remain on track to submit a New Drug Application (NDA) to the FDA in the first half of next year," Mr. Serlin concluded.
About the Pharmacoeconomic Study
The pharmacoeconomic study analyzed healthcare resource utilization (HRU) observed during the Phase 3 GENESIS trial, which randomized 122 patients into two arms: Motixafortide plus G-CSF (n=80) or placebo plus G-CSF (n=42). HRU data points collected include: (1) the number of Motixafortide and G-CSF doses, as well as the number of apheresis sessions performed, in primary mobilization; (2) the percentage of patients needing rescue mobilization due to poor primary mobilization, including the number of apheresis sessions needed and the number of G-CSF and plerixafor doses required; and (3) hospitalization costs related to conditioning and transplantation, including length of stay. Quality-adjusted life years gained (QALY) from published literature were also incorporated into the model. Motixafortide plus G-CSF was associated with a statistically significant HRU decrease during the autologous stem cell transplantation process compared to standard-of-care G-CSF alone. Given the higher number of mobilized cells and lower number of apheresis sessions, lifetime estimates show quality-adjusted-life-year (QALY) benefits and net cost savings of ~$17,000 (not including the cost of Motixafortide), versus the current standard of care.
About the GENESIS Phase 3 Trial
The GENESIS Phase 3 trial (NCT03246529) was initiated in December 2017. GENESIS was a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of Motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients. The primary objective of the study was to demonstrate that only one dose of Motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize 6 million CD34+ cells in up to two apheresis sessions. Additional objectives included time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters. The study successfully met all primary and secondary endpoints with an exceptionally high level of statistical significance (p<0.0001), including approximately 90% of patients who mobilized the target number of cells for transplantation with only one administration of Motixafortide and in only one apheresis session.
About Stem Cell Mobilization for Autologous Stem Cell Transplantation
Autologous stem cell transplantation (ASCT) is part of the standard treatment paradigm for a number of blood cancers, including multiple myeloma, non-Hodgkin's lymphoma and other lymphomas. In eligible patients, ASCT is performed after initial (induction) therapy, and, in most cases, requires consecutive-day clinic visits for the mobilization and apheresis (harvesting) phases, and full hospitalization for the conditioning chemotherapy and transplantation phases until engraftment. The associated burden is therefore significant patients experience clinically relevant deteriorations in their quality of life during ASCT, and healthcare resource use throughout the ASCT phases is particularly intense. Therefore, new interventions impacting the ASCT process have the potential for relieving some of the clinical burden for transplanted patients, the logistical burden for the apheresis units, and the financial burden for healthcare providers and payers.
Described simply, ASCT consists of: (1) mobilizing the patient's own stem cells from his/ her bone marrow to the peripheral blood for removing (harvesting) via an apheresis procedure; (2) freezing and storing the harvested cells until they are needed for transplantation; (3) providing a conditioning treatment, such as high-dose chemotherapy or radiation, to kill the remaining cancer cells the day before transplant; and (4) infusing the stored stem cells back to the patient intravenously via a catheter.
To mobilize the patient's stem cells from the bone marrow to the peripheral blood for harvesting, the current standard of care includes the administration of 5-8 daily doses of granulocyte colony stimulating factor (G-CSF), and the performance of 1-4 apheresis sessions. For patients unable to mobilize sufficient numbers of cells for harvesting during this primary mobilization phase, rescue therapy is carried out, consisting of 1-4 doses of plerixafor on top of G-CSF, and the performance of an additional number of apheresis sessions as necessary. In light of this, an agent with superior mobilization activity may significantly reduce the mobilization and harvesting burden and associated risks of the ASCT process and lead to significant clinical and resource benefits.
About BioLineRx
BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.
The Company's lead program, Motixafortide (BL-8040), is a cancer therapy platform that was successfully evaluated in a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation, as well as reporting positive results from a pre-planned pharmacoeconomic study, and is currently in preparations for an NDA submission. Motixafortide was also successfully evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a clinical trial collaboration agreement with MSD (BioLineRx owns all rights to Motixafortide), and is currently being studied in combination with LIBTAYO and chemotherapy as a first-line PDAC therapy.
BioLineRx is also developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.
For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events.
Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the COVID-19 pandemic; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on February 23, 2021. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.
Contact:Tim McCarthyLifeSci Advisors, LLC+1-212-915-2564[emailprotected]
or
Moran MeirLifeSci Advisors, LLC+972-54-476-4945[emailprotected]
SOURCE BioLineRx Ltd.
Here is the original post:
BioLineRx Announces Positive Results from Pharmacoeconomic Study Positioning Motixafortide as Potential Standard of Care in Stem Cell Mobilization -...
- New Atlas of Rare Stem and Progenitor Cells Reveals New Cell Types - Inside Precision Medicine - March 28th, 2024
- Instructing iPS cell-derived mesenchymal stem cells to inhibit abnormal bone formation in FOP - Medical Xpress - March 28th, 2024
- GLP podcast: GE crops have lived up to the hype; Growing 'mini' organs from stem cells; How do we solve right-wing ... - Genetic Literacy Project - March 28th, 2024
- Exosomes and Stem Cells Are the Future of Anti-Aging - NewBeauty Magazine - March 28th, 2024
- Stem cells: past, present, and future - PMC - National Center for ... - March 19th, 2024
- Stem cells: a comprehensive review of origins and emerging clinical ... - March 19th, 2024
- Biology of stem cells: an overview - PMC - National Center for ... - March 19th, 2024
- What are Stem Cells? - Types, Applications and Sources - BYJU'S - March 19th, 2024
- Stem Cell - The Definitive Guide | Biology Dictionary - March 19th, 2024
- Colossal Creates Elephant Stem Cells for the First Time in Quest to Revive the Woolly Mammoth - Singularity Hub - March 19th, 2024
- Florida congresswoman sued the Pentagon over stem cells. One problem: her husband's stocks - Raw Story - January 23rd, 2024
- Can Stem Cells Improve Knee Pain or Are They A Waste of Money? - Bloomberg - January 23rd, 2024
- Stem cells used to successfully treat arthritis in gorilla at Budapest zoo - University of Sheffield News - January 23rd, 2024
- A computational model of stem cells' internal mechanism to recapitulate spatial patterning and maintain the self ... - Nature.com - January 23rd, 2024
- Advancing the generation of in-vivo chimeric lungs in mice using rat-derived stem cells - EurekAlert - January 6th, 2024
- 'I couldn't just give up on my dad' | Round Rock son donates stem cells to father battling leukemia - KVUE.com - January 6th, 2024
- Closing in on the ultimate quest to regenerate insulin in pancreatic stem cells - Medical Xpress - January 6th, 2024
- Ask the doctors: Research being conducted on using stem cells to treat diabetes - The Spokesman Review - January 6th, 2024
- Regenerative Medicine and COPD: Generating Functional Lungs from Pluripotent Stem Cells - Medriva - January 6th, 2024
- What is a stem cell? YourGenome - December 2nd, 2023
- Stem cell transplant - NHS - December 27th, 2022
- Stem cells: a brief history and outlook - Science in the News - December 27th, 2022
- RUDN Physician And Russian Scientists Investigate Long-term Effects Of Treating Diabetic Ulcers With Stem Cells - India Education Diary - December 27th, 2022
- Stem Cell Basics | STEM Cell Information - National Institutes of Health - December 2nd, 2022
- Neural stem cell - Wikipedia - November 24th, 2022
- Donate Stem Cells | Bone Marrow Donation - American Cancer Society - November 24th, 2022
- Stem Cells- Definition, Properties, Types, Uses, Challenges - November 6th, 2022
- Brothers from Karnataka, Prapul and Prajwal donated their stem cells, save two blood cancer patients - APN News - November 6th, 2022
- Getting These Stem Cells Treatments: Crippled Ronnie Coleman Gives a Positive Update on His Ability to Walk - EssentiallySports - October 21st, 2022
- Cornell Prof Explains Relevance of Creating Mouse Embryos from Stem Cells - Cornell University The Cornell Daily Sun - October 13th, 2022
- Human neuron clusters transplanted into rats offer new tool to study the brain : Shots - Health News - NPR - October 13th, 2022
- The neuroprotective effects of dental pulp stem cells and erythropoietin in mice hippocampus after ischemia-reperfusion - Newswise - October 13th, 2022
- A $7 million grant to grow stem cell research - Swinburne University of Technology - October 13th, 2022
- Stem Cell Manufacturing Global Market Report 2022: Widespread Product Utilization in Effective Disease Management, Personalized Medicine, and Genome... - October 13th, 2022
- Brennand named Elizabeth Mears and House Jameson Professor of Psychiatry - Yale News - October 13th, 2022
- American Academy of Stem Cell Physicians to Offer Licensed Physicians Board Examination in Regenerative Medicine - BioSpace - October 13th, 2022
- Stem Cells - alsa.org - October 4th, 2022
- Mouse embryo models built from stem cells take shape in a dish - Nature.com - October 4th, 2022
- Growth in Cell and Gene Therapy Market - Pharmaceutical Technology Magazine - October 4th, 2022
- Therapeutic Solutions International Identifies CD103 Expressing Dendritic Cells and Exosomes Thereof as Novel Mechanism for JadiCell Mesenchymal Stem... - October 4th, 2022
- Aileron Therapeutics Announces Oral Presentation of Non-Clinical Data Demonstrating ALRN-6924 Protected Human Hair Follicles and Their Stem Cells from... - October 4th, 2022
- Research Shows Promise for Directing Later Lines of Therapy for Hodgkin Lymphoma - Targeted Oncology - October 4th, 2022
- Hereditary E200K mutation within the prion protein gene alters human iPSC derived cardiomyocyte function | Scientific Reports - Nature.com - September 25th, 2022
- How To Eat Your Way to Better Health According to a Doctor - Eat This, Not That - September 25th, 2022
- Phio Pharmaceuticals Announces Preclinical Data Demonstrating PH-762 Enhances Persistence of T cells for Tumor Cell Killing as Presented by Helmholtz... - September 25th, 2022
- Types of blood cancer: Leukemia, lymphoma, and more - Medical News Today - September 25th, 2022
- September: er-blood | News and features - University of Bristol - September 25th, 2022
- Here Is Why You Heal Slower As You Age - Health Digest - September 25th, 2022
- Global Single Cell Analysis Market is Projected to Grow at a CAGR of 15.1% By 2032: Visiongain Reports Ltd - Yahoo Finance UK - September 25th, 2022
- Findings explain exceptional auditory abilities in Williams-Beuren Syndrome - EurekAlert - September 25th, 2022
- Finding the potency in planarians | Communications Biology - Nature.com - September 16th, 2022
- Life-Saving Innovations in Cancer-Fighting Stem Cell Transplants and Pioneering Research in HIV, Autism and Cerebral Palsy to be Featured at World... - September 16th, 2022
- Treating Cancer with Oncolytic Viruses - BioPharm International - September 16th, 2022
- Israel's Profuse Technology Raises $2.5M for Technology That Lowers Cost of Cultured Meat - The Spoon - September 16th, 2022
- Stem Cells Used to Grow Mouse Embryo - BioTechniques - September 8th, 2022
- Largest Gift in UCSD History to Fund Stem Cell Research on Space Station - Times of San Diego - September 8th, 2022
- Global Induced Pluripotent Stem Cells Market (2022 to 2027) - Growth, Trends, Covid-19 Impact and Forecasts - ResearchAndMarkets.com - Business Wire - September 8th, 2022
- Health on the Frontlines: The Healing Power of Stem Cells - Dans Papers - September 8th, 2022
- Top 3 grants in regenerative medicine: July 2022 - RegMedNet - September 8th, 2022
- Childhood leukemia treatment 2022: Where we are now and what it takes - EurekAlert - September 8th, 2022
- Treatment Choices for AML Were Increasingly Influenced by Immunological Responses - Physician's Weekly - September 8th, 2022
- BioRestorative Therapies to Present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14 - StreetInsider.com - September 8th, 2022
- Global Recombinant Cell Culture Supplements Market Report 2022: Increasing Need for Immunotherapies and Stem Cell and Regenerative Medicines Presents... - September 8th, 2022
- CAR-T Beyond CGTs In Development In 2022 - BioProcess Online - September 8th, 2022
- ADOCIA Announces First Cell Therapy Preclinical Proof of Concept of AdoShell Islets for the Treatment of Type 1 Diabetes - Business Wire - September 8th, 2022
- Synthetic Mouse Embryo with Brain and Beating Heart Grown from Stem Cells - Genetic Engineering & Biotechnology News - August 30th, 2022
- Utilization of Modified Induced Pluripotent Stem Cells as the Advance | OPTH - Dove Medical Press - August 30th, 2022
- Rise In Number Of CROS In Various Regions Such As Europe Is Expected To Fuel The Growth Of Induced Pluripotent Stem Cell Market At An Impressive CAGR... - August 30th, 2022
- Brush Up: Hematopoietic Stem Cells and Their Role in Development and Disease Therapy - The Scientist - August 30th, 2022
- Regenerative Properties of the Newborn Heart Offers Hope for Those With Congenital Heart Disease - The Epoch Times - August 30th, 2022
- Kanpur hospital is Indias first to perform fat-derived stem cell transplant for diabetic patients - India Today - August 30th, 2022
- Scientists Just Genetically Edited a Million Years of Evolution Into Mouse DNA - ScienceAlert - August 30th, 2022
- Canadian Blood Services Stem Cells for Life - August 22nd, 2022
- Scientists say they have created 'embryos' without sperm or eggs - Medical News Today - August 22nd, 2022
- Many stem cell lines used for research and therapies carry large number of mutations, Cambridge researchers find - Cambridge Independent - August 22nd, 2022
- Scientists hope to revive extinct mammal through stem cells and gene-editing in a first - The Mirror - August 22nd, 2022
- Stem cell therapy in capsule form - Malaya - August 22nd, 2022
- Cell Culture Technician Pluripotent Stem Cell Biology and Genome Editing job with UNIVERSITY OF SOUTHAMPTON | 305107 - Times Higher Education - August 22nd, 2022
- Long COVID-19 and other chronic respiratory conditions after viral infections may stem from an overactive immune response in the lungs - The... - August 5th, 2022
- Self-organized anteroposterior regionalization of early midbrain and hindbrain using micropatterned human embryonic stem cells - Newswise - July 27th, 2022