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Geron Corporation Announces Appointment of Faye Feller, M.D. to Chief Medical Officer and Transition of Aleksandra Rizo, M.D., Ph.D. to Senior Advisor Role
Rhea-AI Impact
(Low)
Rhea-AI Sentiment
(Very Positive)
Tags
management
Rhea-AI Summary
Geron Corporation (NASDAQ: GERN) has appointed Faye Feller, M.D., as Executive Vice President and Chief Medical Officer effective July 9, 2022. She succeeds Dr. Aleksandra Rizo, who will move to a consulting role after leading imetelstat's development. Dr. Feller has significant experience with imetelstat, having been involved in its development at Geron and previously at Janssen. The company anticipates top-line results from the IMerge Phase 3 trial in early January 2023, which could lead to a New Drug Application submission for imetelstat in lower risk myelodysplastic syndromes.
Positive
Faye Feller's appointment as Chief Medical Officer expected to strengthen leadership.
Continuity in leadership provided by Dr. Rizo remaining as a consultant.
Anticipated top-line readout from IMerge Phase 3 trial could lead to FDA submission.
Negative
Risks of delays in trial results due to potential COVID impacts.
Uncertainty whether top-line results will justify an NDA submission.
Possibility of a clinical hold on IMerge Phase 3 which could delay results.
FOSTER CITY, Calif.--(BUSINESS WIRE)--
Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced the appointment of Faye Feller, M.D., to Executive Vice President and Chief Medical Officer, effective July 9, 2022. Dr. Feller will succeed Dr. Aleksandra Rizo, Geronʻs current Chief Medical Officer, who will transition to a consultant role to the Company, as Senior Medical and Regulatory Advisor. Outside of Geron, Dr. Rizo has accepted a leadership position with a privately held discovery and preclinical-stage platform biotechnology company.
Dr. Feller has been instrumental in the design, execution and management of the imetelstat development program for the past seven years, starting when she served as a medical leader in Janssen’s hematology program. She has continued her work on imetelstat since 2019, as Geronʻs Vice President of Clinical Development reporting to Dr. Rizo.
“Faye has been a cornerstone in the history of imetelstat’s clinical development. Since coming to Geron, she has played a strategic role in designing and driving execution of our Phase 3 clinical trials. In addition, she serves as the primary medical point of contact between Geron and our clinical investigators, leads the preparation of data for assessment by the data monitoring committees, and is preparing for the top-line readout of our IMerge Phase 3 trial in lower risk myelodysplastic syndromes, which is expected in early January 2023,” said John A. Scarlett, M.D., Chairman and Chief Executive Officer. “With her background as clinical lead for multiple clinical trials while at Janssen, and as an attending hematologist at Memorial Sloan Kettering Cancer Center, Faye is highly qualified to assume her new role as our Chief Medical Officer.”
When Dr. Feller becomes Chief Medical Officer, Dr. Rizo will transition to the consultant role, where she will continue to be involved in key imetelstat development and regulatory activities. These include assessment of data for top-line results from the ongoing IMerge Phase 3 trial in lower risk myelodysplastic syndromes (MDS) and, assuming supportive top-line results, through the planned FDA New Drug Application submission and acceptance process for imetelstat in lower risk MDS.
“Aleksandra has made tremendous contributions to the development of imetelstat,” Dr. Scarlett continued. “Her leadership in building and mentoring a deep and experienced development organization is evident with the internal promotion of Faye as Chief Medical Officer. We appreciate the continuity in involvement Aleksandra will provide as Faye assumes her new responsibilities.”
“It has been a privilege to work with Chip and the Geron team to advance this innovative first-in-class telomerase inhibitor, imetelstat, into the late stages of clinical development. I remain confident in the potential of imetelstat to be a transformative treatment for patients with hematologic malignancies, and as such, I am fully committed to continuing to contribute to the imetelstat journey through the potential New Drug Application submission and acceptance process. In particular, I am eager to see the Phase 3 top-line results from the lower risk MDS trial expected in early January 2023,” Dr. Rizo said. “I am also completely confident that imetelstat will be in excellent hands with Faye and the rest our team at Geron, many of whom I have worked with side-by-side on imetelstat over the past seven years, and for whom I have the greatest respect.”
Prior to joining Geron, Dr. Feller was Senior Director at Janssen Research and Development, LLC (Janssen) and both a Compound Lead and Study Responsible Physician for multiple clinical trials of early and late-stage development assets at Janssen, including the IMbark Phase 2 clinical trial of imetelstat. Prior to Janssen, Dr. Feller was an attending physician in the leukemia department of Memorial Sloan Kettering Cancer Center in New York. She received a B.A. from New York University and an M.D. from Mount Sinai School of Medicine. She completed her residency in internal medicine at Mount Sinai Hospital and her fellowship in medical oncology at Memorial Sloan Kettering Cancer Center.
About Geron
Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic malignancies. The Company currently is conducting two Phase 3 clinical trials: IMerge in lower risk myelodysplastic syndromes and IMpactMF in refractory myelofibrosis.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that top-line results from the IMerge Phase 3 trial in lower risk MDS are expected in early January 2023; (ii) that supportive top-line results from the IMerge Phase 3 trial will result in a planned New Drug Application (NDA) submission and acceptance by the FDA for imetelstat in lower risk MDS; (iii) that imetelstat has the potential to be a transformative treatment for patients with hematologic malignancies; and (iv) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, those related to: (a) the timeline in (i) may not be met due to the Company’s inability to manage the procedures necessary for obtaining the top-line results in IMerge Phase 3 or the continuing COVID pandemic; (b) whether the top-line results are positive and result in an NDA being submitted to the FDA and accepted by the FDA; (c) even if approved for commercialization, whether imetelstat demonstrates that it is a transformative treatment; and (d) whether the FDA imposes a clinical hold on IMerge Phase 3 that causes a delay in reporting top-line results or a cessation of the clinical trial. Detailed information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” included in Geron’s quarterly report on Form 10-Q for the quarter ended March 31, 2022. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
