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)

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

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

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

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

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

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

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

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

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.