Phase

Ipsen provides update on CONTACT-02 Phase III trial in metastatic castration-resistant prostate cancer following final overall survival analysis

Retrieved on: 
Sunday, September 15, 2024
Patient, Clinical trial, NHT, Progression-free survival, IPN, Immunotherapy, PFS, Phase, ADR, OS, Pharmaceutical industry

The trial investigated the combination regimen versus a second novel hormonal therapy (NHT) in men previously treated with one NHT and measurable soft-tissue disease.

Key Points: 
  • The trial investigated the combination regimen versus a second novel hormonal therapy (NHT) in men previously treated with one NHT and measurable soft-tissue disease.
  • Based on the results of the final OS analysis and anticipated challenging regulatory environment in the countries in which Ipsen has commercialization rights (outside the US and Japan), Ipsen will not pursue regulatory submissions for this combination regimen in mCRPC.
  • We remain confident, in the proven profile of Cabometyx as a monotherapy and in combination with immunotherapy across approved indications, as well as its ongoing future potential.
  • Ipsen wishes to thank the patients, their families and healthcare teams for their participation in this clinical trial.

FDA Approves Ocrevus Zunovo™ as the First and Only Twice-a-Year 10-Minute Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis

Retrieved on: 
Friday, September 13, 2024
FDA, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, MRI, U.S. FDA, Blood, Patient, Safety, Disease, Multiple sclerosis, PPMS, ROG, Roche, Phase, HCP, RMS, Pharmaceutical industry

Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.

Key Points: 
  • Ocrevus Zunovo is the first and only twice-a-year, healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both these forms of multiple sclerosis, giving people living with MS more treatment options.
  • Injection reactions were more frequently reported with the first injection, with 49% of trial participants experiencing an injection reaction after the first injection.
  • Genentech has more than 30 ongoing multiple sclerosis clinical trials designed to help us better understand the disease and its progression.
  • With Ocrevus Zunovo and Roche and Genentech’s 14 subcutaneous therapies – available across various diseases – we offer additional administration options to meet the diverse preferences of patients.

Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis

Retrieved on: 
Friday, September 13, 2024
MRI, Food and Drug Administration, Blood, Patient, Safety, FDA, Food, Multiple sclerosis, Halozyme, PPMS, Roche, Phase, RMS, SAN, Pharmaceutical industry

SAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Roche received U.S. Food and Drug Administration (FDA) approval for OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) with Halozyme's ENHANZE® drug delivery technology for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) as a twice-a-year, approximately 10-minute subcutaneous (SC) injection to be administered by a healthcare practitioner.

Key Points: 
  • "We are pleased that the subcutaneous formulation of OCREVUS, OCREVUS ZUNOVO, which contains our ENHANZE drug delivery technology, is now approved in the U.S. for patients with these two forms of multiple sclerosis," said Dr. Helen Torley, president and chief executive officer of Halozyme.
  • "OCREVUS ZUNOVO offers greater treatment flexibility and optionality for patients with multiple sclerosis and their healthcare providers."
  • The most common adverse events with OCREVUS ZUNOVO were injection reactions, all of which were either mild or moderate, and none of which led to treatment withdrawal.
  • Out of the exploratory outcomes measured, OCREVUS ZUNOVO was consistent with IV, demonstrating suppression of relapse activity (97%) and MRI lesions (97%) through 48 weeks.

Cytovation to present full safety and efficacy data from the CICILIA Phase I/IIa trial evaluating CY-101 in solid tumors at ESMO 2024

Retrieved on: 
Friday, September 13, 2024
Pembrolizumab, Neoplasm, Patient, FDA, Adrenocortical carcinoma, Diagnosis, ESMO, ACC, Merck, Phase, WNT, Merk, Cancer, Merck & Co., Antigen, Pharmaceutical industry

Furthermore, these data demonstrate early signs of antitumor activity, especially in tumors with dysregulated Wnt/β-catenin signaling.

Key Points: 
  • Furthermore, these data demonstrate early signs of antitumor activity, especially in tumors with dysregulated Wnt/β-catenin signaling.
  • Interim results from CICILIA were reported in 2023 (link to press release here ) confirming that all trial endpoints were met, with CY-101 demonstrating a consistent safety profile across tumor types and strong early signals of efficacy.
  • Data from the ESMO poster show that no dose-limiting toxicities were observed in the dose- escalation part of the study with the RP2D defined at 20 mg.
  • Separately, the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to CY-101 monotherapy for the treatment of ACC.

FDA Approves Genentech’s Tecentriq Hybreza, the First and Only Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

Retrieved on: 
Friday, September 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Medicine, Blood, Patient, Safety, Physician, Skin, Lung, RN, Food, Liver, ROG, Phase, Roche, Pharmaceutical industry

Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab).

Key Points: 
  • Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab).
  • It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin and soft tissue cancer.
  • “By enabling subcutaneous administration for a cancer immunotherapy, Tecentriq Hybreza now offers patients with multiple cancer types and their physicians greater flexibility and choice of treatment administration,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.
  • With Tecentriq Hybreza and Roche/Genentech’s 13 other subcutaneous therapies – available across various diseases – we offer additional administration options to meet the diverse preferences of patients.

OmRx Oncology Launches to Advance Investigational Oral Checkpoint Inhibitor Designed to Increase Access to Cancer Immunotherapy Worldwide

Retrieved on: 
Thursday, September 12, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Neoplasm, Entrepreneurship, Antibody, Patient, Safety, Gilead Sciences, Cancer, PD-1, PD-L1, Immunotherapy, Phase, Scripps Research, Scripps, Executive, Lung cancer, Global health, NSCLC, Pharmaceutical industry

The clinical-stage asset, OX-4224, discovered and initially developed by Gilead Sciences, is an investigational oral immune checkpoint inhibitor that targets the PD-1/PD-L1 pathway and will be evaluated by OmRx for the treatment of patients with non-small cell lung cancer (NSCLC).

Key Points: 
  • The clinical-stage asset, OX-4224, discovered and initially developed by Gilead Sciences, is an investigational oral immune checkpoint inhibitor that targets the PD-1/PD-L1 pathway and will be evaluated by OmRx for the treatment of patients with non-small cell lung cancer (NSCLC).
  • OmRx is wholly focused on advancing this clinical-stage program, first as a monotherapy in low and middle-income countries, and eventually, globally for potential all-oral combination therapies.
  • The company is led by a high-caliber team with expertise in cancer R&D, clinical development, entrepreneurship, and corporate development.
  • “Immune checkpoint inhibitor monoclonal antibodies represent one of the most important treatment advances in cancer in the past two decades, but they are essentially unavailable to cancer patients outside of the major commercial markets.

UNESCO-Huawei Open School Initiative Set to Transform Education in Egypt, Brazil and Thailand

Retrieved on: 
Wednesday, September 11, 2024
School, Education, Digital, Educational technology, Teacher, UNESCO, Forum, Phase, Partnership, Distance, Student, ICT, Vocational education, Tutoring

Running from 2024 to 2027, Phase II of the UNESCO-Huawei initiative will support the digital transformation of education in each of the three nations through digital open school models.

Key Points: 
  • Running from 2024 to 2027, Phase II of the UNESCO-Huawei initiative will support the digital transformation of education in each of the three nations through digital open school models.
  • The announcement was made at the Technology-enabled Open Schools for All Forum hosted by UNESCO and Huawei during Digital Learning Week.
  • Dr. Yaw Osei Adutwum, Minister of Education for Ghana; delegates from the ministries of education from Ethiopia, Brazil, and Thailand; and representatives from UNESCO and Huawei.
  • The Open School projects in Brazil and Thailand will serve as benchmarks for the Latin America and ASEAN regions, respectively.

UNESCO-Huawei Open School Initiative Set to Transform Education in Egypt, Brazil and Thailand

Retrieved on: 
Wednesday, September 11, 2024
School, Education, Digital, Educational technology, Teacher, UNESCO, Forum, Phase, Partnership, Distance, Student, ICT, Vocational education, Tutoring

Running from 2024 to 2027, Phase II of the UNESCO-Huawei initiative will support the digital transformation of education in each of the three nations through digital open school models.

Key Points: 
  • Running from 2024 to 2027, Phase II of the UNESCO-Huawei initiative will support the digital transformation of education in each of the three nations through digital open school models.
  • The announcement was made at the Technology-enabled Open Schools for All Forum hosted by UNESCO and Huawei during Digital Learning Week.
  • Dr. Yaw Osei Adutwum, Minister of Education for Ghana; delegates from the ministries of education from Ethiopia, Brazil, and Thailand; and representatives from UNESCO and Huawei.
  • The Open School projects in Brazil and Thailand will serve as benchmarks for the Latin America and ASEAN regions, respectively.

Canter Resources Intersects Third Aquifer Zone at Columbus Lithium-Boron Project

Retrieved on: 
Tuesday, September 10, 2024
Lithium, News, Columbus Basin, Collection, Crystallization, Canter and gallop, Environment, Mineral, OTC Markets Group, Phase, Salt, National instrument, Technical advisor, Boron, QP, Borate, Sodium chloride, CRC

Vancouver, British Columbia--(Newsfile Corp. - September 10, 2024) - Canter Resources Corp. (CSE: CRC) (OTC Pink: CNRCF) (FSE: 6O1) ("Canter" or the "Company") is pleased to report that it has completed Phase II Geoprobe drilling at its Columbus Lithium-Boron Project ("Columbus" or the "Project"), located near Tonopah, Nevada.

Key Points: 
  • Vancouver, British Columbia--(Newsfile Corp. - September 10, 2024) - Canter Resources Corp. (CSE: CRC) (OTC Pink: CNRCF) (FSE: 6O1) ("Canter" or the "Company") is pleased to report that it has completed Phase II Geoprobe drilling at its Columbus Lithium-Boron Project ("Columbus" or the "Project"), located near Tonopah, Nevada.
  • Geoprobe Phase II Program Highlights:
    Deepest Hole to Date: Hole CB24-010G reached the greatest depth of the two programs at 124 feet (37.8 metres), identifying three distinct aquifer zones.
  • Halite Bed Continuity: Multiple holes encountered the halite marker bed, indicating continuity across a notable strike length.
  • For more information about boron and lithium, please visit the Company's Boron 101 and Lithium 101 pages on the website.

Delta-Fly Pharma Inc.: Phase I/II Combo-study of DFP-10917 with Venetoclax in Patients with AML Initiates Enrollment of Patients

Retrieved on: 
Tuesday, September 10, 2024
Oncology, Health, FDA, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Acute myeloid leukemia, DNA, University, Drug discovery, Patient, Safety, IRB, Progression-free survival, Cancer, Food, Hospital, PFS, Phase, NDA, VEN, New Drug Application, AML, Pharmaceutical industry

The University of Virginia Hospital is the clinical site that enrolled the most patients to the Phase III study of DFP-10917 monotherapy in patients with failed/relapsed AML.

Key Points: 
  • The University of Virginia Hospital is the clinical site that enrolled the most patients to the Phase III study of DFP-10917 monotherapy in patients with failed/relapsed AML.
  • Some pharmaceutical companies have already expressed interest in the Phase III study of DFP-10917 monotherapy.
  • Accordingly, we are going to supply much more welcome combo-therapy of VEN and DFP-10917 (G2/M arrest) comparing to current standard AML therapy.
  • After successful completion of this Phase I/II study, Delta-Fly Pharma, Inc. will cooperate with a mega pharmaceutical company objective NDA (New Drug Application).