The amount of clinical news in 2022 continues to lag last year, partly due to a decline in COVID-19-related data. Through the last week of September, there have been a total of 2,495 phase I, II and III clinical entries, compared with 3,027 during the first three quarters of 2021. This represents a drop in activity of 17.6%.
Polaris Pharmaceuticals Inc.’s pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of significant improvement in progression-free survival in patients enrolled in the pivotal phase II/III Atomic study in malignant pleural mesothelioma.
Boston Scientific Corp. and Abbott Laboratories continue to parry over clinical trials comparing the latter’s Amplatzer Amulet with Boston Scientific’s Watchman in sealing the heart’s left atrial appendage (LAA) to prevent ischemic stroke in patients with atrial fibrillation (Afib). In one of five presentations at the 34th Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston in mid-September, Abbott said device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Abbott’s Amplatzer Amulet device.
In recent years, ethicists have executed a 180-degree shift on including children in clinical trials testing drugs, biologics and medical devices, moving from the idea that it was unethical to include youngsters in trials to an understanding that such inclusion may be the best way of protecting them.
Valneva SE is approaching a crucial point with its troubled efforts to develop a COVID-19 vaccine, having announced Sept. 26 it’s in talks with a potential partner for its next-generation jab. The company cautioned the negotiations could take several months and may not succeed. The company’s problems with its COVID-19 vaccine, which is based on an inactivated whole virus, have weighed on its shares (Paris:VLA), which collapsed from a 52-week high of more than €29 (US$28.29) in December 2021 to €5.74 at the close of trading Sept. 26.
Alkermes plc’s recent update on sales of the schizophrenia drug Lybalvi (also indicated for bipolar I disorder) along with positive phase III data from Karuna Therapeutics Inc. from tests of Karxt (xanomeline plus trospium) shone more light on the troublesome indication, where Cerevel Therapeutics Holdings Inc. is advancing emraclidine in what could be a registrational phase II study.
Volta Medical SAS reported validation for its VX1 software mapping system, an artificial intelligence (AI) algorithm compatible with most commonly available multi-pole catheters and technology used in operating rooms and cath labs for treating cardiac arrhythmia. Results from the proof-of-concept-study were published in the Journal of Cardiovascular Electrophysiology.
Aggressive prostate cancer disproportionately affects—and kills—African American men, but identifying which men are at highest-risk has proved challenging, particularly in younger patients. Veracyte Inc.’s Decipher prostate genomic classifier could help identify these men with early, localized prostate cancer at the greatest risk of aggressive disease, a new study published in the Journal of the National Cancer Institute found.
DBV Technologies SA blindsided investors by disclosing that the U.S. FDA had placed a partial clinical hold on its phase III Vitesse trial of its Viaskin Peanut patch immunotherapy for peanut allergy, calling for several changes to the study protocol. Its demands came just two weeks after the company claimed to have finalized the protocol in consultation with the agency.
Polaris Pharmaceuticals Inc.’s pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of significant improvement in progression-free survival in patients enrolled in the pivotal phase II/III Atomic study in malignant pleural mesothelioma.
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