Wednesday, September 20, 2017 1:01:10 PM
Currently, Geron, with its partner Janssen (JNJ), has two trials ongoing for imetelstat - IMbark, a Phase 2 trial in myelofibrosis (MF) and IMerge, a Phase 2/3 trial in myelodysplastic syndromes (MDS). Geron is awaiting Janssen’s decision to continue with part 2 of the IMerge trial based on “Feedback from ongoing FDA interactions, data from the expanded Part 1, and other imetelstat program information, including the protocol-specified primary analysis for IMbark, are expected to inform Janssen’s decision of whether to move forward to Part 2 of IMerge.” A subset of 13 patients of the 32 total enrolled patients who had not received prior treatment with either a hypomethylating agent (HMA) or lenalidomide and did not have a del(5q) chromosomal abnormality showed an increased durability and rate of transfusion independence compared to the overall trial population (≥8-week RBC-TI: 53.8% vs 34.4%). An additional 20 patients who are non-del5q and naïve to HMA and lenalidomide treatment are being enrolled to verify this data. The press release quoted does not discuss data from the other 19 patients.
The other trial, IMbark, is a Phase 2 trial in patients with Intermediate-2 or High Risk MF who have relapsed after or are refractory to prior treatment with a JAK inhibitor. This trial continues as planned, and to date, median overall survival has not yet been reached in either the 4.7 mg/kg or 9.4 mg/kg dosing arm. Janssen will provide details of whether it continues or not upon the earlier of either a pre-specified number of deaths occurring in the trial or the end of the third quarter of 2018. Basically, both trials currently hang in the balance, but the IMbark trial looks more likely to continue with Janssen - that is our opinion. If Janssen continues, the opt-in/out considerations will set in for Geron, and we have two scenarios here.
Recent GERN News
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 09/19/2024 08:30:00 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 09/09/2024 08:35:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/09/2024 08:35:03 PM
- Geron Corporation Announces Appointment of Jim Ziegler as Chief Commercial Officer • Business Wire • 09/09/2024 08:15:00 PM
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 08/22/2024 08:30:00 PM
- Geron Corporation Reports Second Quarter 2024 Financial Results and Business Highlights • Business Wire • 08/08/2024 11:00:00 AM
- Geron Announces Updated NCCN Guidelines® Recommending RYTELO™ (imetelstat) for the Treatment of Symptomatic Anemia in Patients with Lower-Risk MDS • Business Wire • 07/26/2024 11:30:00 AM
- Geron Corporation Announces Chief Commercial Officer to Depart at End of August 2024 • Business Wire • 07/23/2024 08:15:00 PM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/10/2024 08:05:04 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 07/08/2024 07:44:18 PM
- Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 06/20/2024 08:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/12/2024 08:05:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/12/2024 08:05:04 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/10/2024 09:53:19 PM
- Form 144 - Report of proposed sale of securities • Edgar (US Regulatory) • 06/10/2024 04:30:13 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:08 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:06 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:03 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/07/2024 08:10:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/07/2024 08:03:44 PM
- Geron Announces FDA Approval of RYTELO™ (imetelstat), a First-in-Class Telomerase Inhibitor, for the Treatment of Adult Patients with Lower-Risk MDS with Transfusion-Dependent Anemia • Business Wire • 06/07/2024 01:58:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/05/2024 08:05:20 PM
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