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Enrolls First Patients Articles & Analysis
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“This designation allows us to broaden our reach and provide innovative solutions to more healthcare professionals treating patients diagnosed with PE – on an increasingly global scale.” An estimated 435,000 PE events occur each year in the six largest European Union (EU) countries.1 Compared to the United States, the prevalence of PE is higher for those ...
“We thank The PERT Consortium™, including our enrolling partners, for its commitment to generating robust clinical evidence to help address the needs of this patient population.” APEX-AV is a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE ...
Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, headquartered in New York and focused on bringing transformational oncology treatments for cancer patients, will commercialize ORSERDU in the U.S. “The FDA approval of ORSERDU marks the first ever therapy for ER+, HER2- advanced or metastatic breast cancer ...
” At data cutoff (July 16, 2022), 51 of 52 patients enrolled in the Phase 2 expansion phase of the trial had received at least one dose of tulmimetostat in the following cohorts: metastatic castration-resistant prostate cancer, lymphoma, BAP1-mutated mesothelioma, ARID1A-mutated ovarian clear cell carcinoma, ARID1A-mutated endometrial carcinoma and ...
Iterative Scopes, a pioneer in precision-medicine technologies for gastroenterology, announced today that it has partnered with One GI®, a gastroenterology management services organization (MSO), to bring its AI Recruitment (AIR) technology to One GI’s clinical research. Initially, One GI® will use AIR at Gastro One, one of One GI’s clinical research sites in Memphis, ...
ATG-037 is Antengene’s oral small molecule CD73 inhibitor; KEYTRUDA® (pembrolizumab) is MSD’s anti-PD-1 therapy The clinical trial collaboration will focus on evaluating ATG-037 as a monotherapy and in combination with KEYTRUDA® for the treatment of locally advanced or metastatic solid tumors The study of ATG-037 monotherapy started enrolling ...
This agreement covers the execution of a Phase 2 clinical trial to evaluate the novel combination of Carrick’s samuraciclib (CT7001), an oral and first-in-class inhibitor of CDK7, and Menarini‘s oral selective estrogen receptor degrader (SERD), elacestrant, in patients with CDK4/6i resistant HR+, HER2- metastatic breast cancer. ...
The dose levels that are evaluated in the Phase 1 part of the study are 50x106 (DL1), 110x106 (DL2) and 250x106 (DL3). As of 8 November 2022, 9 patients were enrolled; baseline and safety data for 8 patients were available (n=4 at DL1; n=4 at DL2). 7 patients reached the follow-up period of 28-days and were eligible for efficacy ...
Elacestrant demonstrated longer progression-free survival (PFS) vs SOC endocrine therapy with medians up to 8.6 months, positively associated with the duration of prior treatment with CDK4/6 inhibitors Elacestrant side effects were manageable and consistent with previously reported results Results demonstrate that elacestrant may have the potential to become a new standard of care as a ...
“The Zephyr Valve is a breakthrough technology because it is the first bronchoscopic procedure option that can provide significant improvements to patients with no improvement in their symptoms despite optimal medical therapy,” stated Prof. ...
“We anticipate top-line data from SERENITY III as well as our TRANQUILITY II trial for Alzheimer’s-related agitation in the first half of 2023. These two near-term pivotal data readouts further reinforce the potential of BXCL501 to address the unmet medical needs of millions of ...
The Phase 3 clinical trial will be a multi-center, double-blind, randomized, placebo-controlled trial in the United States. BRIM plans to enroll more than 700 patients with moderate to severe DED. The clinical trial is expected to be completed in the fourth quarter of 2023, depending on the status of patient enrollment. ...
Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced plans for a Phase 1/2a trial of narazaciclib combined with letrozole in recurrent metastatic low-grade endometrioid endometrial cancer (LGEEC). In addition, the Company reported its third ...
INB-100 continued to demonstrate durable morphologic complete responses in the Phase 1 clinical trial in patients with leukemia; on track to announce additional data at upcoming ASH annual meeting. ...
Walid Abi-Saab, Chief Medical officer, at Galapagos said, “We are excited to present data at ACR which highlights our continued commitment to patients and the healthcare provider community, in particular initial data from our first international, real-world arthritis study. We believe that it’s not only important to control disease activity to prevent ...
The Peter MacCallum Cancer Centre (“Peter Mac”) and Cartherics Pty Ltd (“Cartherics”) announced today they have entered into a Collaborative Development Program Agreement (CDPA) to develop Cartherics’ proprietary autologous CAR-T cell therapy (CTH-001) for the treatment of cutaneous T-cell lymphoma (CTCL). “Patients with advanced stages of cutaneous T-cell ...
Data support the potential of INB-100 to induce long-term durable responses in patients with high-risk or relapsed acute myeloid leukemia (AML). Clinical activity observed includes continuing robust durability of relapse-free survival; all three patients in Cohort 1 remain alive and progression-free; ongoing durations of response exceed 12 months and extend ...
“Every day, we see advanced cancer patients with limited treatment options. We intend to initiate the study in the U.S. soon, and hope that ATG-017 will eventually offer a safe and effective new treatment option to those patients in ...
Patients’ directly reported outcomes in certain rare and chronic diseases are considered reliable for understanding the disease’s natural history, palliative treatments that focus primarily on symptom control, and quality of life. Electronic Patient-Reported Outcome Measures (ePROMs) are now allowing these patients to self-report health conditions and treatment effectiveness ...
(NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous and other diseases, announced positive in-hospital and 30-day outcomes from the fully-enrolled 500-patient CLOUT registry. The company also reported positive results from a ...