Successful completion of a pharma industry-sponsored study to measure the electrophysiologic effects of ketamine on healthy brain function. The study (EBS-B) included 24 healthy subjects who made three visits to the CenExel Hassman Research Institute (HRI) study site where they were administered a sub-anesthetic dose of ketamine on two of the three visits and placebo on the other visit. The sequence of ketamine or placebo dosing was randomized across the three subject visits. All subjects were counseled by a site clinician with expertise in ketamine experiences / side effects (e.g., dissociati ..read more

ATOMIC (Academic Thoracic Oncology Medical Investigators Consortium), met at the IASLC 2023 Targeted Therapies of Lung Cancer symposium in February in Santa Monica. ATOMIC is an innovative research model that has brought together an expert team of institutions and investigators to design and rapidly complete clinical trials in thoracic and lung cancer with the ultimate goal of identifying new drugs to treat this disease.  Leading the group is D. Ross Camidge, MD, PhD. Dr. Camidge is Professor of Medicine/Oncology and holds the Joyce Zeff Chair in Lung Cancer Research at the University of ..read more

Positive one-year results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study. About PADN series trials Multipolar Synchronous Pulmonary Artery Radiofrequency Ablation Instrument Based on the importance of sympathetic hyperactivation in the progression of pulmonary hypertension (PH). PADN, a minimally invasive procedure was proposed that involves radiofrequency ablation through the femoral vein into the pulmonary artery to effectively damage the sympathetic nerves around the pulmonary artery and improve the pressure response of pulmonary artery traction receptors.  PADN is an ..read more

AGICC (Academic GI Cancer Consortium) met in person for an Investigator’s Meeting during the recent GI-ASCO 2023 Symposium in San Francisco. This coming year the AGICC group will continue to explore GI oncology trials in partnership with pharmaceutical companies.  Leading the group is Wells A. Messersmith, M.D. University of Colorado Cancer Center, Aurora, CO. Dr. Messersmith trained in internal medicine at Massachusetts General Hospital / Harvard Medical School and did his Medical Oncology / Drug Development Fellowship at Johns Hopkins, where he was on faculty as Assistant Professor in t ..read more

AURIC (Academic Urology Research Investigators Consortium) met for an initial Investigator’s Meeting during the recent GU-ASCO 2023 in San Francisco to explore new studies for the coming year. The group’s primary focus is to partner with pharmaceutical companies looking to explore novel genitourinary oncology trials.  Leading the group is Thomas Flaig, M.D., University of Colorado, Denver. Dr. Flaig was appointed vice chancellor for research for the CU Denver and CU Anschutz Medical Campus in March of 2020. In 2016, he became the inaugural chief clinical research officer of UCHealth and a ..read more

Superior quality Precision Plasmids™ expedite clinical trial timelines with no wait time to start manufacturing custom plasmids Biostat CultiBag STR The Center for Breakthrough Medicines (CBM), a contract development, and manufacturing organization (CDMO), has launched its plasmid manufacturing offering, Precision Plasmids™ to provide phase-appropriate plasmid on-demand for any company seeking to accelerate their path to clinic for cell and gene therapies. CBM offers NO WAIT TIMES for Precision Plasmids™ R&D grade for pre- and early clinical phases, and Precision Plasmids™ Pro grade for to ..read more

The FDA approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. The new drug’s starting dose is given as oral tablets and subcutaneous injections, followed by maintenance injections every six months. It is given in combination with other antiretroviral(s). Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1 ..read more

AURIC Director Thomas Flaig, MD, of the University of Colorado Anschutz Medical Campus in Aurora, Colorado, provides an overview of the management of toxicities with novel systemic therapies in patients with urothelial carcinoma (UC), highlighting the use of antibody-drug conjugates in advanced disease. This interview took place at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium 2022 in San Francisco, CA. https://www.criteriuminc.com/wp-content/uploads/2022/12/Thomas-Flaig-MD-Mgmt-of-toxicities-w-novel-systemic-therapies-in-UC-02MAR2022.mp4   About Thomas ..read more

Eating a Mediterranean diet, rich in fiber, mono-unsaturated fatty acids and polyphenols, has been associated with improved immunotherapy response rates and progression-free survival in advanced melanoma patients. Experts anticipate that the diet will play an important role in the success of immunotherapy and trials are being expanded to investigate outcomes for different tumour types, including digestive cancers. A Mediterranean diet, containing mono-and polyunsaturated fats from olive oil, nuts and fish, polyphenols and fiber from vegetables, fruit, and wholegrains, was significantly associa ..read more

Novel Oral Suspension Formulation of Abiraterone Acetate Designed to Address Needs of Metastatic Prostate Cancer Patients Who Have Difficulty Swallowing (Dysphagia), an Issue for 20 to 30 Percent of Prostate Cancer Patients Completion of patient enrollment in pivotal Phase 3 study for TAVT-45 (abiraterone acetate) Granules for Oral Suspension (“TAVT-45”). TAVT45CO2 is a global Phase 3 clinical trial evaluating TAVT-45 in patients with metastatic castrate-sensitive prostate cancer (mCSPC) and metastatic castrate-resistant prostate cancer (mCRPC). The primary objective of the study is to establi ..read more