Geron to Assume Sponsorship of Myelofibrosis IST and IND
Menlo Park, Calif., August 5, 2014 - Geron Corporation (Nasdaq: GERN) announced today that the company has entered into a transfer agreement with Mayo Clinic whereby the Investigational New Drug (IND) application for imetelstat under which the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST) has been conducted will be transferred from Mayo Clinic to Geron. In addition, Geron will assume sponsorship for the Myelofibrosis IST, and Dr. Ayalew Tefferi will remain the principal investigator for the study. The company and Mayo Clinic have agreed that the IND and sponsorship responsibility for the conduct of the Myelofibrosis IST will be transferred to Geron by September 30, 2014. In light of the full clinical hold placed on the company's IND, Geron has committed to the U.S. Food and Drug Administration (FDA) that the company will not initiate any new clinical studies under the transferred IND from Mayo Clinic until Geron has had further communication with the FDA regarding the company's IND and development plans for imetelstat.
The Myelofibrosis IST ceased enrolling patients in January 2014. Under Geron's sponsorship, the patients remaining in the study - which include patients with myelofibrosis (MF), blast phase MF, and refractory anemia with ringed sideroblasts, a subtype of the myelodysplastic syndromes (RARS-MDS) - will continue to receive treatment with imetelstat or continue in follow-up. Geron does not intend to enroll additional patients in this study. The company plans to use the transferred data and information from the Myelofibrosis IST to inform the design of Geron's planned Phase 2 clinical trial in MF.
These developments will be discussed during Geron's second quarter conference call to be held on Monday, August 11, 2014, at 4:30 p.m. Eastern Time. Information for participating in the conference call is available on the company's website at www.geron.com.
Geron is a clinical stage biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for statements of historical fact, this press release contains forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding: projected timelines for transfer of the IND for the Myelofibrosis IST to Geron and assumption of sponsorship of the Myelofibrosis IST by Geron; plans for imetelstat Phase 2 clinical trial initiation; the continued treatment or follow-up of remaining patients in the Myelofibrosis IST after the IND transfer; and other statements that are not historical fact. 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, risks and uncertainties regarding: the timing and process of transferring the IND for the Myelofibrosis IST to Geron; the timing and process of moving sponsorship of the Myelofibrosis IST to Geron; whether the data and information from the Myelofibrosis IST is sufficient to inform the design of Geron's Phase 2 clinical trial in MF; whether the FDA permits Geron to proceed with a Phase 2 clinical trial in MF; whether there are any significant safety issues arising from the Myelofibrosis IST; and those other risks and uncertainties inherent in the development of potential therapeutic products such as successful company-sponsored clinical trial results, technical, scientific and regulatory challenges, sufficient capital resources, limitations on Geron's freedom to operate arising from intellectual property of others, and challenges to or enforcement of Geron's intellectual property rights. Additional detailed information and factors that could cause actual results to differ materially from those in the forward-looking statements is contained in Geron's periodic reports filed with the Securities and Exchange Commission primarily under the heading "Risk Factors," including in Geron's quarterly report on Form 10-Q for the quarter ended March 31, 2014. Undue reliance should not be placed on Geron's forward-looking statements, and Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
Kevin Eng, Ph.D.
Anna Krassowska, Ph.D.
Investor and Media Relations