Niraparib

Allarity Therapeutics Makes Strategic Pivot to Focus Solely on Accelerating Stenoparib Toward Regulatory Approval in Advanced Recurrent Ovarian Cancer

Retrieved on: 
Wednesday, March 27, 2024
Toxicity, Ovarian cancer, BRCA, Mirvetuximab soravtansine, Partnership, Patient, Neoplasm, Cancer, Merck, Doctor of Philosophy, Olaparib, WNT, Niraparib, Jiangsu Hengrui Medicine, PARP, Therapy, Safety, Platinum, Interim, Rucaparib, Pharmaceutical industry

This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023.

Key Points: 
  • This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023.
  • In addition, stenoparib is unique in its mechanism of action, inhibiting PARP as well as the novel cancer target, tankyrase.
  • Tankyrase inhibition would restrain the WNT pathway, which is commonly upregulated not only in ovarian cancers but in many other solid cancers.
  • Given the unique, dual mechanism of action for stenoparib—coupled with its favorable safety profile—stenoparib may represent the next-generation alternative in the evolving market for advanced ovarian cancer patients.

Zai Lab to Present Final Overall Survival (OS) Data from Phase 3 NORA Study of ZEJULA (niraparib) in Platinum-Sensitive Recurrent Ovarian Cancer (PSROC)

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, Other Health, Health, General Health, Women, Pharmaceutical, Oncology, Research, Consumer, Science, Clinical Trials, Progression-free survival, Fudan University, Shanghai Cancer Center, ISD, PARP, ESGO, BRCA, HKEX, Platelet, OS, Gynecologic Oncology (journal), Ovarian cancer, SGO, Patient, Congress, Development, Niraparib, Pharmaceutical industry

“Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.

Key Points: 
  • “Previous progression-free survival and interim OS data from the NORA study demonstrated the benefit of niraparib maintenance therapy with an individualized starting dose among Chinese patients with PSROC,” said Dr. Rafael Amado, President, Head of Global Oncology Research and Development, Zai Lab.
  • “We look forward to sharing the final OS findings from this study at both the 2024 ESGO and SGO conferences.
  • The final OS analysis was conducted after ≥ 50% of OS events occurred in the intent-to-treat population.
  • No new safety signals were identified during the long-term follow up period subsequent to the primary analysis.

Metastatic Castration-Resistant Prostate Cancer Market is Predicted to Exhibit Remarkable Growth at a CAGR of 7.5% During the Study Period (2019-2032), Estimates DelveInsight

Retrieved on: 
Wednesday, December 20, 2023
GT0918, Niraparib, Phase, Ipsen, CRPC, Prognosis, Daiichi Sankyo, PSMA, BRCA, FDA, Spacecraft, Gesellschaft mit beschränkter Haftung, DNA, EU4, Cancer, Novartis, ICIS, Abiraterone acetate, Ageing, Urination, PSA, Metastasis, CYP17, Survival rate, Pain, Prevalence, Bristol Myers Squibb, Prednisone, Janssen Pharmaceuticals, Testosterone, PARP, Rucaparib, Urine, Neoplasm, Urethra, Johnson & Johnson, AstraZeneca, Docetaxel, STEAP1, Bone pain, AMG, Blood, ADT, LAS, Patient, Prostate-specific antigen, Astellas Pharma, HRR, Amgen, Prostate cancer, Swelling, Eli Lilly and Company, Hypoesthesia, Science, Growth, Merck & Co., Pressure, Pharmaceutical industry

LAS VEGAS, Dec. 20, 2023 /PRNewswire/ -- DelveInsight's Metastatic Castration-Resistant Prostate Cancer Market Insights report includes a comprehensive understanding of current treatment practices, mCRPC emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • As per DelveInsight analysis, the total metastatic castration-resistant prostate cancer market size in the 7MM was estimated to be nearly USD 6.4 billion in 2022, which is expected to show positive growth by 2032.
  • As per DelveInsight estimates, in 2022, total diagnosed prevalent cases of mCRPC were around 127K in the 7MM.
  • However, mCRPC remains a lethal diagnosis and more effective therapeutic approaches against mCRPC are necessary to improve clinical outcomes further.
  • The estimated five-year survival rate for men with metastatic prostate cancer is approximately 30%, in stark contrast to the 100% survival rate for those with localized prostate cancer.

Metastatic Castration-Resistant Prostate Cancer Market is Predicted to Exhibit Remarkable Growth at a CAGR of 7.5% During the Study Period (2019-2032), Estimates DelveInsight

Retrieved on: 
Wednesday, December 20, 2023
GT0918, Niraparib, Phase, Ipsen, CRPC, Prognosis, Daiichi Sankyo, PSMA, BRCA, FDA, Spacecraft, Gesellschaft mit beschränkter Haftung, DNA, EU4, Cancer, Novartis, ICIS, Abiraterone acetate, Ageing, Urination, PSA, Metastasis, CYP17, Survival rate, Pain, Prevalence, Bristol Myers Squibb, Prednisone, Janssen Pharmaceuticals, Testosterone, PARP, Rucaparib, Urine, Neoplasm, Urethra, Johnson & Johnson, AstraZeneca, Docetaxel, STEAP1, Bone pain, AMG, Blood, ADT, LAS, Patient, Prostate-specific antigen, Astellas Pharma, HRR, Amgen, Prostate cancer, Swelling, Eli Lilly and Company, Hypoesthesia, Science, Growth, Merck & Co., Pressure, Pharmaceutical industry

LAS VEGAS, Dec. 20, 2023 /PRNewswire/ -- DelveInsight's Metastatic Castration-Resistant Prostate Cancer Market Insights report includes a comprehensive understanding of current treatment practices, mCRPC emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].

Key Points: 
  • As per DelveInsight analysis, the total metastatic castration-resistant prostate cancer market size in the 7MM was estimated to be nearly USD 6.4 billion in 2022, which is expected to show positive growth by 2032.
  • As per DelveInsight estimates, in 2022, total diagnosed prevalent cases of mCRPC were around 127K in the 7MM.
  • However, mCRPC remains a lethal diagnosis and more effective therapeutic approaches against mCRPC are necessary to improve clinical outcomes further.
  • The estimated five-year survival rate for men with metastatic prostate cancer is approximately 30%, in stark contrast to the 100% survival rate for those with localized prostate cancer.

Ivy Brain Tumor Center Announces Promising Data for Niraparib in Phase 0/2 Glioblastoma Clinical Trial

Retrieved on: 
Friday, November 17, 2023
Temozolomide, Glomus tumor, Barrow Neurological Institute, Brain, Safety, Annual general meeting, PST, Progression-free survival, Glioblastoma, Clinical trial, Patient, Thrombocytopenia, PFS, Radiation, Pakistan Society of Neuro-Oncology, GSK, PARP, Standard of care, MGMT, Niraparib, Survival, Society, SNO, HIV disease progression rates, Hedera, Pharmaceutical industry, Medical imaging, Oncology

Phoenix, AZ, Nov. 17, 2023 (GLOBE NEWSWIRE) -- The Ivy Brain Tumor Center at Barrow Neurological Institute announces promising results from a Phase 0/2 trial of niraparib in patients with newly diagnosed glioblastoma with unmethylated MGMT.

Key Points: 
  • Phoenix, AZ, Nov. 17, 2023 (GLOBE NEWSWIRE) -- The Ivy Brain Tumor Center at Barrow Neurological Institute announces promising results from a Phase 0/2 trial of niraparib in patients with newly diagnosed glioblastoma with unmethylated MGMT.
  • Glioblastoma is an incurable malignant brain tumor and MGMT-unmethylated glioblastoma is the most common and fastest-recurring variant, comprising more than 60 percent of all glioblastoma tumors.
  • In the Phase 0 component of the study, patients exposed to niraparib demonstrated high drug concentrations in brain tumor tissue.
  • These presentations represent a broader portfolio of pharmacodynamic and pharmacokinetic-driven clinical trials, utilizing industry-supported drug development to test new-in-class therapies for brain tumor patients.

Zai Lab Announces the First Listing of VYVGART® (efgartigimod alfa injection) and Other Updates in China’s National Reimbursement Drug List

Retrieved on: 
Wednesday, December 13, 2023
Neurology, Biotechnology, Pharmaceutical, Managed Care, Oncology, Health, Infectious Diseases, Health Insurance, Acetylcholine receptor, HKEX, GMG, Patient, Zai, Ovarian cancer, Niraparib, NRDL, Pharmaceutical industry

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications:

Key Points: 
  • Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the 2023 National Reimbursement Drug List (NRDL) released by China’s National Healthcare Security Administration (NHSA) has been updated to include the following medicines and indications:
    VYVGART® (efgartigimod alfa injection) is included for the first time in the NRDL for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive;
    ZEJULA® (niraparib) is renewed for the maintenance treatment of adult patients with platinum-sensitive, first-line and recurrent ovarian cancer.
  • “The initial NRDL inclusion for VYVGART is an especially important milestone for gMG patients and underscores the clinical value Zai Lab is delivering to the medical community and to patients in China,” said William Liang, Chief Commercial Officer of Zai Lab.
  • “We are pleased that we now have four products included in the NRDL, and we will continue our efforts to expand patient access to our innovative treatments, including through NRDL coverage of different indications and formulations for our commercial products.
  • We are grateful for this action by the NHSA, and we look forward to continuing to work with the NHSA to improve patient access and costs for high-quality treatments in China.”

CanariaBio Announces Enrollment Completion of Phase 2 Study of Oregovomab in Combination with Niraparib in the Treatment of Recurrent Ovarian Cancer

Retrieved on: 
Tuesday, August 8, 2023
GSK, Ovarian cancer, KOSDAQ, Niraparib, Immunization, Recurrence, PARP, Patient, PFS, ADP, Pharmaceutical industry, Oregovomab

SEOUL, S.KOREA, Aug 8, 2023 - (ACN Newswire) - CanariaBio, a KOSDAQ-listed and a leading late-stage biotechnology company, announces the successful enrollment completion of a Phase 2 study of Oregovomab in combination with niraparib, GSK's poly (ADP-ribose) polymerase (PARP) inhibitor, for treatment of patients with platinum-sensitive recurrent ovarian cancer.

Key Points: 
  • SEOUL, S.KOREA, Aug 8, 2023 - (ACN Newswire) - CanariaBio, a KOSDAQ-listed and a leading late-stage biotechnology company, announces the successful enrollment completion of a Phase 2 study of Oregovomab in combination with niraparib, GSK's poly (ADP-ribose) polymerase (PARP) inhibitor, for treatment of patients with platinum-sensitive recurrent ovarian cancer.
  • This trial, known as FLORA-4 (NCT05335993), is being conducted by CanariaBio, with GSK providing clinical trial supply of niraparib.
  • The study will assess the immunological and clinical activity, early humoral response, and disease control rate of concomitant Oregovomab and daily oral niraparib.
  • This will be a preliminary investigation of the interaction of indirect immunization with Oregovomab and concomitant niraparib therapy and the immune modulatory effects associated with PARP inhibition.

Ivy Brain Tumor Center Announces Interim Results of Two Clinical Trials Targeting High-Grade Glioma

Retrieved on: 
Friday, June 2, 2023
Glioma, Abstract (summary), Glioblastoma, Methylation, Drug development, MGMT, Survival, American Society of Clinical Oncology, Niraparib, Brain, ASCO, Barrow Neurological Institute, Radiation therapy, MD, Neuro, PARP, Society, Hedera, Medical imaging, Pharmaceutical industry, Patient

A Phase 0/1b clinical trial was selected for presentation and withdrawn pending resolution of outstanding patent details.

Key Points: 
  • A Phase 0/1b clinical trial was selected for presentation and withdrawn pending resolution of outstanding patent details.
  • Abstracts from the clinical trials of infigratinib and niraparib are now online in the ASCO Meeting Library and will be presented by Ivy Center investigators on June 3, 2023 at the ASCO Central Nervous System Tumors poster session.
  • These new results do not support the continued clinical development of infigratinib in adult glioma patients.
  • “The use of Phase 0 clinical trials in neuro-oncology has never been more critical,” says Nader Sanai, MD, director of the Ivy Brain Tumor Center and director of neurosurgical oncology at Barrow Neurological Institute.

Panavance Therapeutics Announces Positive Preclinical Data Demonstrating GP-2250 Single-Agent and Combination Activity for the Treatment of Ovarian Cancer

Retrieved on: 
Monday, April 17, 2023
Orange County Convention Center, Panaveli, Bevacizumab, AACR, GAPDH, ATP, Quality of life, American Association for Cancer Research, Paclitaxel, Gynecologic Oncology (journal), Niraparib, Monroe Dunaway Anderson, Assistant, MD Anderson Cancer Center, HRMS, Olaparib, Patient, AKT, Translational research, University, Cancer, Ultra, MTT, HK2, Poster, Rucaparib, RNA interference, Reproductive medicine, Ovarian cancer, PARP, Therapy, Hand, Pharmaceutical industry

BERWYN, Pa., April 17, 2023 (GLOBE NEWSWIRE) -- Panavance Therapeutics Inc. (“Panavance” or the “Company”), a clinical-stage pharmaceutical company advancing the development of a novel oncology therapeutic intended to improve the outcomes and quality of life for the patients that receive them, today announced that positive data from the Company’s tumor cell selective and broadly active small molecule with a unique mechanism of action, GP-2250 (misetionamide), was presented at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL.

Key Points: 
  • “The data generated by GP-2250 to date has continued to demonstrate promising treatment potential for cancers.
  • These findings are encouraging and provide valuable insight as we advance the development of GP-2250 for the treatment of ovarian cancer.
  • With this growing body of data, we look forward to further evaluating GP-2250’s potential in the treatment of ovarian cancer,” commented Greg Bosch, Chairman and CEO of Panavance Therapeutics.
  • Dr. Sood commented, “There remains a significant unmet need in treatment options for ovarian cancer.

IRBM Selected for Participation in National Chemical Biology Consortium

Retrieved on: 
Tuesday, April 4, 2023
Vaccine, Drug development, FNLCR, Therapy, Frederick National Laboratory for Cancer Research, Cancer, Research, Experiment, IRBM, Vivo, Bangladesh Technical Education Board, Organization, National Cancer Institute, American Society for Pharmacology and Experimental Therapeutics, CBC, Patient, NeXT, Leidos, Drug discovery, Knowledge, Niraparib, NCI, Pharmaceutical industry

IRBM’s CEO Matteo Liguori said: “We are privileged to have been selected to participate in the CBC with the vital mission of progressing oncology programs globally, delivering transformational treatments for patients worldwide.

Key Points: 
  • IRBM’s CEO Matteo Liguori said: “We are privileged to have been selected to participate in the CBC with the vital mission of progressing oncology programs globally, delivering transformational treatments for patients worldwide.
  • Members contribute their expertise in high throughput screening, structural biology, medicinal chemistry, compound profiling, cancer cell biology, and in vivo & in vitro models for oncology.
  • IRBM is the only member based outside the USA to be part of the CBC network.
  • IRBM is an innovative research organization working across all aspects of drug discovery and early development.