Clinical trials

Infinity Pharmaceuticals Presents Updated Data from Phase 2 MARIO-275 Trial in Urothelial Cancer (UC) and Phase 2 MARIO-3 Trial in Triple Negative Breast Cancer (TNBC)

Oncology, Health, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Clinical medicine, Cancer treatments, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Monoclonal antibodies, Carcinoma, Transitional cell carcinoma, Nivolumab, PD-L1, Pembrolizumab
Tuesday, July 27, 2021 - 12:31pm

These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.

Key Points: 
  • These data provide preliminary, but compelling evidence of eganelisibs potential to improve outcomes for patients with these two types of cancer.
  • These results are consistent with the results from MARIO-275, which show the similar translation of disease control into a meaningful survival benefit for patients.
  • For patients with TNBC, the potential to extend progression free survival, regardless of PD-L1 status, would be a transformational breakthrough.
  • MARIO-275 is a global, randomized, controlled combination study of eganelisib combined with Opdivo in I/O nave urothelial cancer.

Antibe Therapeutics Provides July 2021 Corporate Update

Biotechnology, Pharmaceutical, Health, Clinical trials, Antibe Therapeutics, Forward-looking statement, Medicine, Screening, Articles, Health sciences
Tuesday, July 27, 2021 - 12:00pm

Antibe is taking a comprehensive approach to maximizing the likelihood of a successful Phase III program outcome.

Key Points: 
  • Antibe is taking a comprehensive approach to maximizing the likelihood of a successful Phase III program outcome.
  • The program also combines several state-of-the-art aspects, including the hiring of leading providers of bioanalytic, quality control and data management services.
  • The latter will enable us to track and manage screening and enrollment in real-time, ensuring that the subject population matches trial criteria.
  • Antibe Therapeutics assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.

Verastem Oncology Announces Updated Phase 1/2 FRAME Study Data in Low Grade Serous Ovarian Cancer Selected for a Mini Oral Presentation at the European Society of Medical Oncology Congress 2021

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer, Health, KRAS, Clinical medicine, Gastrointestinal cancer, Uveal melanoma, Melanoma, Verastem Oncology, Pancreatic cancer, MEK inhibitor
Tuesday, July 27, 2021 - 12:00pm

Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.

Key Points: 
  • Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches.
  • The company-sponsored, registration-directed Phase 2 RAMP 201 study is well underway, with top-line results from the selection phase expected during the first half of 2022.
  • The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC.
  • Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma.

FDA Gives Green Light for Multiple Sclerosis Stem Cell Trial

Research, FDA, Clinical trials, Philanthropy, Stem cells, Biotechnology, General Health, Health, Foundation, Science, Branches of biology, Biology, Life sciences, Stem cells, Biotechnology, Cell biology, Cloning, Developmental biology, Mesenchymal stem cell, Adult stem cell, Stem-cell therapy, Shimon Slavin
Tuesday, July 27, 2021 - 12:00pm

Non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a randomized, double-blind, single center, Phase II clinical trial to assess the efficacy of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells in improving symptoms and quality of life in patients with mild-to-moderate multiple sclerosis (MS).

Key Points: 
  • Non-profit research organization Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a randomized, double-blind, single center, Phase II clinical trial to assess the efficacy of multiple intravenous infusions of autologous adipose-derived mesenchymal stem cells in improving symptoms and quality of life in patients with mild-to-moderate multiple sclerosis (MS).
  • A single infusion in the treatment group consists of 200 million stem cells, or approximately 1.2 billion stem cells per patient over the course of study.
  • HBSCRF remains the only organization globally to administer pure, fresh mesenchymal stem cells, an adult stem cell harvested from fat, in such high quantities over repeat treatments.
  • Clinical trial authorizations encompass COVID-19 prevention and treatment , traumatic brain injury , Parkinsons disease , and multiple sclerosis.

David P. White, M.D. Appointed Senior Vice President of Medical Affairs at Apnimed

Biotechnology, General Health, Medical devices, Health, Clinical trials, Sleep disorders, Branches of biology, Sleep apnea, Obstructive sleep apnea, Apnea, Sleep, Sleep medicine, International Classification of Sleep Disorders
Tuesday, July 27, 2021 - 12:30pm

Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for obstructive sleep apnea and related disorders, today announced that David P. White, M.D., a world-renowned leader in sleep disorders has been appointed Senior Vice President of Medical Affairs.

Key Points: 
  • Apnimed, a clinical-stage company focused on advancing pharmacologic treatments for obstructive sleep apnea and related disorders, today announced that David P. White, M.D., a world-renowned leader in sleep disorders has been appointed Senior Vice President of Medical Affairs.
  • Clinicians understand that obstructive sleep apnea is a prevalent and debilitating medical condition affecting the health and well-being of patients.
  • There is a tremendous unmet need for a safe, effective, and easy-to-use treatment option that addresses the underlying cause of the disease.
  • In addition to his new position at Apnimed, Dr. White is a Professor of Medicine, part-time, at Harvard Medical School in Boston, Mass.

Oragenics Enters into Licensing Agreement with the National Research Council of Canada, to Pursue the Rapid Development of Next-Generation SARS-CoV-2 Vaccines

Biotechnology, Infectious diseases, Health, Pharmaceutical, Clinical trials, Coronaviridae, Articles, Sarbecovirus, Health, Zoonoses, Animal virology, Coronavirus, Severe acute respiratory syndrome coronavirus 2, Severe acute respiratory syndrome, Pandemic, Vaccine, COVID-19
Tuesday, July 27, 2021 - 12:00pm

Oragenics, Inc. (NYSE American: OGEN) today announced it has entered into a licensing agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue the rapid development of next-generation vaccines against the SARS-CoV-2 virus and its variants.

Key Points: 
  • Oragenics, Inc. (NYSE American: OGEN) today announced it has entered into a licensing agreement with the National Research Council of Canada (NRC) that will enable Oragenics to pursue the rapid development of next-generation vaccines against the SARS-CoV-2 virus and its variants.
  • The NRC technologies, developed with support from the NRCs Pandemic Response Challenge Program, will expedite the evaluation of SARS-CoV-2 antigen candidates in preclinical and clinical studies.
  • Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases including coronaviruses and multidrug-resistant organisms.
  • Its lantibiotics program features a novel class of antibiotics against infectious diseases that have developed resistance to commercial antibiotics.

Biodesix to Report Second Quarter 2021 Financial Results on August 10, 2021

Biotechnology, Health, Clinical trials, Other Health, Medical specialties, Branches of biology, Clinical medicine, Immunology, Antibodies, Chemical pathology, Communication, Forward-looking statement, Anti-SSA/Ro autoantibodies, Vaccine
Tuesday, July 27, 2021 - 11:00am

Biodesix is the first company to offer seven non-invasive tests for patients with diseases of the lung, including three proteomic tests.

Key Points: 
  • Biodesix is the first company to offer seven non-invasive tests for patients with diseases of the lung, including three proteomic tests.
  • The antibody tests can detect antibodies that are generated both from infection by the virus and from the vaccines.
  • Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors.
  • Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law.

FDA Approves KEYTRUDA® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery

Oncology, Health, FDA, Infectious diseases, Clinical trials, Pharmaceutical, Biotechnology, Clinical medicine, Cancer, Drugs, Orphan drugs, Breakthrough therapy, Pyridines, Antineoplastic drugs, Cancer immunotherapy, Pembrolizumab, Merkel-cell carcinoma, Sorafenib, Axitinib
Tuesday, July 27, 2021 - 11:30am

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points: 
  • KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma.
  • KEYTRUDA is indicated for the treatment of patients with high-risk early-stage TNBC in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

XyloCor Therapeutics Commences Phase 2 Component of Phase 1/2 EXACT Clinical Study of XC001 Gene Therapy for Refractory Angina

Cardiology, Biotechnology, Pharmaceutical, Surgery, Health, FDA, Genetics, Clinical trials, Medical specialties, Circulatory system, Cardiac surgery, Clinical medicine, Coronary artery bypass surgery, Angina, Coronary arteries, Heart diseases, Cardiogenesis Corporation, Coronary artery disease
Tuesday, July 27, 2021 - 12:00pm

XyloCor also confirms that it plans to submit an additional Phase 2 clinical study to the U.S. Food and Drug Administration (FDA) for XC001 as adjunctive therapy to coronary artery bypass grafting (CABG) in 2H21.

Key Points: 
  • XyloCor also confirms that it plans to submit an additional Phase 2 clinical study to the U.S. Food and Drug Administration (FDA) for XC001 as adjunctive therapy to coronary artery bypass grafting (CABG) in 2H21.
  • It is very exciting to now move forward with exploring XC001s potential in the Phase 2 portion of EXACT as a one-time therapy for patients with refractory angina.
  • XyloCor commenced the EXACT Trial, a Phase 1/2 study of XC001 in chronic refractory angina, in 2020.
  • The Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (EXACT) clinical trial is a Phase 1/2 multicenter, open-label, single-arm, dose-escalation trial.