Interim

medicine

Stan Gerson to continue as CWRU School of Medicine’s interim dean through summer 2022

Stan Gerson, interim dean for the Case Western Reserve University School of Medicine, will continue in his term through June 30, 2022, according to a news release.

CWRU’s interim president, Scott Cowen, and provost Ben Vinson III announced the one-year extension on Tuesday, Oct. 20.

“We knew Stan’s deep familiarity with the medical school and its hospital partners would give him distinct advantages as he started in this role,” Cowen said in a provided statement. “But his ability to apply them in such an engaging and inclusive way has far exceeded even our heightened expectations. We are delighted he will helm the school throughout the 2021-2022 academic year.”

Gerson is a Distinguished University Professor and longtime director of the Case Comprehensive Cancer Center (CCCC), a consortium including CWRU, Cleveland Clinic and University Hospitals.

Gerson accepted the interim role after now-president emerita Barbara R. Snyder announced she would step down to lead the Association of American Universities starting Oct. 1. Gerson had been serving as co-chair for the university’s search for a new medical school dean, but Snyder and Vinson decided her successor should get to choose the next permanent dean, given that the medical school is responsible for about 80% of the university’s research and 43% of its revenues, according to the release. Pamela B. Davis, who previously held the dean title, announced in 2018 her plans to step back from that role and rejoin the faculty.

“Once we decided to appoint an interim dean, Stan quickly emerged as a top choice,” Vinson said in a provided statement. “Not only is he a renowned researcher in his own right, but he also has helped elevate our cancer center to distinguished prominence, making it among the nation’s most highly regarded programs.”

While serving as interim dean and with support from his leadership team, Gerson is continuing to lead the CCCC, which in 2018 received a $31.9 million grant and the highest possible rating from the National Cancer Institute. It has 400 investigators across the three institutions and supports roughly 15,000 people newly diagnosed with cancer each year, according to the release.

“I am honored by the confidence that the interim president and provost have shown in me by awarding this extension and look forward to continuing to work with our faculty, staff, students and hospital partners to advance education, research and our community’s well-being during the next 20 months,” Gerson said in a provided statement.

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CytoDyn Receives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial

DSMC recommends CytoDyn continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint

DSMC also requests another data review when enrollment reaches 293 patients (75%) to analyze all data, including survival rate at 42 days

VANCOUVER, Washington, Oct. 20, 2020 (GLOBE NEWSWIRE) — CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today recommendations from the Data Safety Monitoring Committee (DSMC) following its review of the interim analysis of the Company’s Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The interim analysis was performed on data from the first 195 (50%) of 390 planned patients.

The DSMC had three recommendations to consider following its review of the interim analysis:

  1. Stop the trial due to safety concerns;

  2. Continue the trial with modification (i.e., increase the sample size to maintain the power to achieve the primary endpoint); or

  3. Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.

The DSMC recommends the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level (or 293 patients) to review patient mortality and other clinical outcome data between the two study arms (leronlimab vs. placebo). Trial enrollment is currently at 230 patients. The Company is working diligently to accelerate patient enrollment in the U.S. and U.K. to achieve the enrollment goal of 293 patients as quickly as possible (potentially in 4-6 weeks), with the goal of full enrollment (390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days.

CytoDyn’s Phase 2b/3 trial to evaluate the efficacy and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered via subcutaneous injection. The study has three phases: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured in this study is: all-cause mortality at Day 28. Secondary outcomes measured are: (1) all-cause mortality at Day 14, (2) change in clinical status of subject at Day 14, (3) change in clinical status of subject at Day 28, and (4) change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14.

CytoDyn’s President and Chief Executive Officer, Nader Pourhassan, Ph.D., stated, “We are grateful to the DSMC members for their diligence, guidance and support. We are very pleased by the DSMC’s recommendation and this encouraging interim analysis adding to the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients. Concurrently, we are seeking ongoing guidance from the U.S. Food and Drug Administration and regulatory agencies in other countries for a swift regulatory approval pathway for leronlimab to treat COVID-19.

During today’s

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