MDS

Geron Announces IMerge Phase 3 Presentations at ASH Highlighting Significant Durability of Transfusion Independence and Breadth of Effect Across MDS Subgroups with Imetelstat in Lower Risk MDS

Retrieved on: 
Monday, December 11, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Yale Cancer Center, Associate, International Prognostic Scoring System, Quality, IPSS, VAF, ASH, Acute myeloid leukemia, Cytopenia, Risk, Pros, Corporation, Yale school, Fatigue, Patient, Thrombocytopenia, Research, Periodic breathing, Imetelstat, Quality of life, Internal medicine, MDS, Neutropenia, MBBS, Yale School of Medicine, Bleeding, Survival, Pain, AML, Geron Corporation, Society, Iron overload, Mutation, RBC, Pharmaceutical industry, Dietary supplement, Lancet, Geron, SF3B1, Blood, Medicine, Hematology

The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.

Key Points: 
  • The results showed that imetelstat consistently had higher RBC-TI response rates than placebo across these different risk subgroups.
  • Overall, durable 24-week and 1-year RBC-TI responses were observed with imetelstat in all lower- and higher-risk subgroups.
  • This analysis suggests clinical benefit of imetelstat across different molecularly defined subgroups and independent of the underlying molecular mutation pattern.
  • This analysis indicates that achievement of RBC-TI was associated with improved survival, suggesting that transfusion dependence is a modifiable predictor of clinical outcomes in lower risk MDS.

Orca Bio Presents Positive Data Demonstrating the Potential for Orca-T and Orca-Q to Expand Treatment to Additional Patient Groups at the 65th ASH Annual Meeting

Retrieved on: 
Saturday, December 9, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, MAC, Thiotepa, NRM, Safety, Toxicity, CTCAE, Incidence, ASH, Acute myeloid leukemia, Acute leukemia, Syndrome, Risk, University, Mortality, Patient, Busulfan, Infection, BFT, RFS, MDS, Graft-versus-host disease, HSCT, Cancer, Trial of the century, CML, Toxic epidermal necrolysis, Bone marrow, AML, RIC, MD Anderson Cancer Center, Physician, OS, Quality of life, Society, ALL, Face, Pharmaceutical industry, Vaccine, Dentistry, Medical imaging

The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.

Key Points: 
  • The results presented at the 65th American Society of Hematology (ASH) Annual Meeting showed promising data with the use of Orca Bio’s cell therapies across several patient groups where there is significant unmet medical need.
  • Results highlighted in an oral presentation showed Orca-T’s ability to deliver similar outcomes in older patients undergoing myeloablative conditioning (MAC) as younger patients.
  • In this subgroup from the ongoing multi-center Phase 1b clinical trial, Orca-T demonstrated promising results in this patient population (n=16).
  • The estimated incidence of CTCAE grade 2 and greater than grade 3 infections at one year were 9% and 15%, respectively.

Bristol Myers Squibb Presents Primary Efficacy and Safety Analysis of the Phase 3 COMMANDS Trial of Reblozyl for Treatment of Anemia in Erythropoiesis Stimulating Agent-Naïve Patients with Lower-Risk Myelodysplastic Syndromes at ASH 2023

Retrieved on: 
Saturday, December 9, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Bristol Myers Squibb, NYSE, European Commission, University, ASH, HB, Civil service commission, Patient, ASCO, BMY, Merck, ESA, MDS, Myelodysplastic syndrome, Anemia, MD Anderson Cancer Center, Society, RBC, ITT, Epoetin alfa, Pharmaceutical industry, Dietary supplement

These data are being presented in an oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting, from December 9-12.

Key Points: 
  • These data are being presented in an oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting, from December 9-12.
  • Reblozyl is being developed and commercialized through a global collaboration with Merck as of November 2021.
  • At the time of the primary analysis (March 31, 2023), 363 patients were randomized 1:1 to Reblozyl and epoetin alfa.
  • Erythroid response (HI-E) increase of at least 8 weeks was achieved by 74.2% (n=135) of Reblozyl patients vs. 53% (n=96) of epoetin alfa patients (p

Geron Announces Publication in The Lancet of Results from the IMerge Phase 3 Clinical Trial Evaluating Imetelstat in Lower Risk MDS

Retrieved on: 
Monday, December 4, 2023
Biotechnology, Pharmaceutical, Health, Clinical Trials, Lancet, Imetelstat, Safety, Food, European Medicines Agency, Risk, Corporation, EMA, Serum, Patient, Thrombocytopenia, FDA, EPO, MDS, Neutropenia, Anemia, Geron Corporation, Manuscript, Infection, Therapy, Pharmaceutical industry

Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced publication in The Lancet of results from the IMerge Phase 3 trial investigating imetelstat versus placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).

Key Points: 
  • Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced publication in The Lancet of results from the IMerge Phase 3 trial investigating imetelstat versus placebo in patients with lower risk myelodysplastic syndromes (MDS) relapsed/refractory or ineligible for erythropoiesis stimulating agents (ESAs).
  • “With regards to the safety results, neutropenia and thrombocytopenia were predictable and manageable, with little to no significant clinical consequences.
  • Significant and clinically meaningful efficacy results were achieved across key MDS subgroups irrespective of ring sideroblast (RS) status, baseline transfusion burden and IPSS risk category.
  • Consistent with prior imetelstat clinical experience, the most common adverse events were thrombocytopenia and neutropenia that were manageable and of short duration.

XetaWave Offers Compatible Solutions for Obsolete X710 & SD Series and TransNET™ Radios and a Migration Path & Replacement for FGR2, FGR2-IO & MM2 Radios

Retrieved on: 
Thursday, December 14, 2023
SD2, Compatibility, Wireless, Radio, SD4, KBPS, INS, Hertz, ISM, SD9, Transnet, MDS, MAS, Data-rate units, GE MDS

LOUISVILLE, Colo., Dec. 14, 2023 /PRNewswire/ -- XetaWave, a Colorado-based leader in wireless technology, announced that it now offers Compatible Solutions that enable XetaWave radios to be installed and interoperate in non-XetaWave networks including GE MDS X710, SD Series, and TransNET networks. This enables customers to extend the life of their existing networks by replacing inoperable and unsupported radios as needed and then transition to the newer technology and more advanced features of XetaWave networks as time and budget permit. Jonathan Sawyer, XetaWave Founder and CEO, commented, "Unlike other companies, XetaWave products are and always will be 100% backward compatible and we are steadfast in our commitment to providing cost effective, compatible solutions and replacement products for legacy networks that eliminate the need and significant cost associated with replacing an entire network."

Key Points: 
  • LOUISVILLE, Colo., Dec. 14, 2023 /PRNewswire/ -- XetaWave, a Colorado-based leader in wireless technology, announced that it now offers Compatible Solutions that enable XetaWave radios to be installed and interoperate in non-XetaWave networks including GE MDS X710, SD Series, and TransNET networks.
  • XetaWave unlicensed (ISM) Xeta9, Xeta9x, and Xeta9s 900 MHz radios are compatible with and can interoperate with MDS TransNET radios.
  • XetaWave offers a cost-effective migration path from legacy FreeWave networks with its XetaINS, an Intelligent Network Synchronizer (INS).
  • Compatible Solutions are included within XetaWave radios and existing fielded XetaWave radios can support Compatible Solutions through a firmware update.

Notable Labs Donates $60,000 to MDS Foundation to Accelerate Progress for Patients with Myelodysplastic Syndromes

Retrieved on: 
Wednesday, December 13, 2023
Education, Notability, ASH, Patient, Research, Move, Caregiver, MDS, MD, Cancer, LHC Accelerator Research Program, Society, Nursing, Boston

SAN DIEGO, Dec. 13, 2023 /PRNewswire/ -- Notable Labs, Ltd. ("Notable") (Nasdaq: NTBL), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced that it has donated $60,000 to the Myelodysplastic Syndromes Foundation, Inc. This donation was formally announced during the MDS Foundation 2023 Satellite Symposium at the 65th American Society of Hematology (ASH) Annual Meeting in San Diego, which was also supported by Notable.

Key Points: 
  • "This funding reflects our deep commitment to developing better treatments for patients with MDS who deserve the fastest possible progress in fighting this severe, life-threatening disease," said Thomas Bock, MD, CEO, Notable Labs.
  • "I am truly excited about partnering with the MDS Foundation in fighting this severe and life-threatening condition.
  • "We are extremely grateful to Notable Labs for their generous sponsorship of our 2023 Move for MDS Community Walks," said Tracey Iraca, Executive Director, MDS Foundation.
  • "The funds raised by the MDS Foundation are used to educate patients and caregivers, as well as to raise awareness of MDS in the community.

Notable Labs Funds Myelodysplastic Syndromes Foundation with $60,000 Grant

Retrieved on: 
Monday, December 11, 2023
Education, Notability, ASH, Disease, Patient, Research, Caregiver, MDS, MD, Cancer, LHC Accelerator Research Program, Society, Pharmaceutical industry, Boston

SAN DIEGO, Dec. 11, 2023 /PRNewswire/ -- Notable Labs, ("Notable") (Nasdaq: NTBL), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced that it has donated $60,000 to the Myelodysplastic Syndrome Foundation, Inc. This donation was formally announced during the MDS Foundation 2023 Satellite Symposium at the 65th American Society of Hematology (ASH) Annual Meeting which Notable Labs also supported here in San Diego, Ca.

Key Points: 
  • Funds will help advance MDS Education, Advocacy and Research
    SAN DIEGO, Dec. 11, 2023 /PRNewswire/ -- Notable Labs, ("Notable") (Nasdaq: NTBL), a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, today announced that it has donated $60,000 to the Myelodysplastic Syndrome Foundation, Inc.
  • This donation was formally announced during the MDS Foundation 2023 Satellite Symposium at the 65th American Society of Hematology (ASH) Annual Meeting which Notable Labs also supported here in San Diego, Ca.
  • Notable Labs served as a National Gold Sponsor of the 2023 "Move for MDS Community Walks to Drive Awareness & Accelerate Research.
  • "We are extremely grateful to Notable Labs for their generous sponsorship of our 2023 Move for MDS walks," said Tracey Iraca, Executive Director, MDS Foundation.

Taiho Oncology Announces Presentation of Data From a U.S. Real-Word Study of Oral Decitabine and Cedazuridine

Retrieved on: 
Sunday, December 10, 2023
Yale Cancer Center, Bone marrow, Associate, Safety, Senior, Travel, ASH, MHS, Syndrome, HMA, Patient, Abstract, DEC, Medical Affairs Bureau, Index, Caregiver burden, MDS, MBBS, Yale School of Medicine, MHA, MD, Society, Majesty of the Seas, Pharmaceutical industry, Hematology

Data from the study were shared during an oral presentation ( Abstract #548 ) at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition.

Key Points: 
  • Data from the study were shared during an oral presentation ( Abstract #548 ) at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition.
  • Based on these results and the potential for reduced treatment burden, oral decitabine and cedazuridine may be a viable alternative to intravenous or subcutaneous HMAs."
  • In this study of 1,569 patients, 160 received oral DEC-C and 1,409 received intravenous/subcutaneous (IV/SC) HMAs.
  • As a leader in the development of orally administered anti-cancer agents, Taiho Oncology is pleased to see how outcomes of this real-world study show some of the potential benefits of an oral therapy in myelodysplastic syndromes."

Servier Showcases Leadership in Mutant Isocitrate Dehydrogenase (IDH) Inhibition Through New Data Spotlighting Real-World Treatment Patterns and Clinical Outcomes of Tibsovo® Use at ASH 2023

Retrieved on: 
Saturday, December 9, 2023
Human, Research, PST, FN, Toxicity, Incidence, ASH, Commercial, Acute myeloid leukemia, Syndrome, Hematology, HMA, Febrile neutropenia, Patient, MRD, Science, Exposition, MDS, IDH, IDH1, Diagnosis, Chondrosarcoma, CCA, AML, Doctor of Philosophy, Cancer, Society, Mutation, ALL, Health, Pharmaceutical industry, Ivosidenib, Medicine

BOSTON, Dec. 9, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, will be presenting new data in acute myeloid leukemia (AML) at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. These data provide a compelling and in-depth look into the treatment patterns and clinical outcomes observed in real-world settings, offering valuable insights for informed decision-making in patient care.

Key Points: 
  • These data provide a compelling and in-depth look into the treatment patterns and clinical outcomes observed in real-world settings, offering valuable insights for informed decision-making in patient care.
  • In the analysis of 238 patients, Tibsovo+HMA elicited a higher complete response (CR) rate versus venetoclax+HMA at 42.9% vs. 26.7% (p=0.007).
  • Median time from diagnosis to start of treatment was 14 versus 20 days for Tibsovo+HMA vs venetoclax+HMA.
  • "At Servier, we bring the patient voice into everything we do, and our commitment to patients extends far beyond approval," emphasized Becky Martin, PhD, Chief of Medical, Servier Pharmaceuticals.

Rigel Pharmaceuticals and MD Anderson Announce Strategic Alliance to Advance REZLIDHIA® (Olutasidenib) in AML and Other Cancers

Retrieved on: 
Friday, December 8, 2023
Rigel, SAN, Food, Acute myeloid leukemia, Patient, Myelocyte, FDA, MPN, Monroe Dunaway Anderson, MDS, IDH1, Pancreatic serous cystadenoma, University, AML, MD Anderson Cancer Center, Cancer, Mutation, Pharmaceutical industry, Leukemia

Under the strategic collaboration, Rigel and MD Anderson will evaluate the potential of olutasidenib to treat newly diagnosed and relapsed or refractory (R/R) patients with AML, higher-risk myelodysplastic syndromes (MDS), and advanced myeloproliferative neoplasms (MPN), in combination with other agents.

Key Points: 
  • Under the strategic collaboration, Rigel and MD Anderson will evaluate the potential of olutasidenib to treat newly diagnosed and relapsed or refractory (R/R) patients with AML, higher-risk myelodysplastic syndromes (MDS), and advanced myeloproliferative neoplasms (MPN), in combination with other agents.
  • "We are excited to enter into this strategic alliance with the exceptional team at MD Anderson to evaluate REZLIDHIA as a potential therapy for a broad range of IDH1-mutant cancers," said Raul Rodriguez, Rigel's president and CEO.
  • We look forward to a close collaboration with MD Anderson to advance this as a new therapeutic option for more patients."
  • Rigel and MD Anderson will jointly lead all clinical development efforts, which will be overseen by a joint steering committee.