Shares of Geron Corporation (NASDAQ:GERN) ended Friday session in red amid volatile trading. The shares closed down -0.09 points or -4.57% at $1.88 with 4.20million shares getting traded. Post opening the session at $1.97, the shares hit an intraday low of $1.84 and an intraday high of $1.99 and the price vacillated in this range throughout the day. The company has a market cap of $285.51 million and the numbers of outstanding shares have been calculated to be 159.14 million shares.
Geron Corporation (GERN) on Sept. 12, 2016 provided updates on the clinical trials being conducted by Janssen Research & Development, LLC, of the telomerase inhibitor imetelstat. Planned internal reviews of initial data from both trials have been completed by Janssen, and both trials are continuing in order to evaluate additional and more mature data.
IMbarkTM (NCT02426086) was originally designed as a Phase 2 clinical trial to evaluate two dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered every three weeks) in approximately 200 patients (approximately 100 patients per dosing arm) with Intermediate-2 or High risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. The co-primary efficacy endpoints for the trial are spleen response rate and symptom response rate at 24 weeks. To date, over 90 patients have been enrolled in the trial across both dosing arms.
To inform an assessment of the appropriate dose and schedule for relapsed or refractory MF patients in IMbarkTM, Janssen conducted a planned internal interim review of safety, efficacy and pharmacokinetic data from 20 patients from each dosing arm who have been followed on the trial for at least 12 weeks. Based on this first internal review at the early 12-week time point, the following has been determined by Janssen:
- The safety profile was consistent with previous imetelstat clinical trials in hematologic myeloid malignancies. No new safety signals were identified.
- Activity in the 4.7 mg/kg dosing arm does not warrant further investigation of that dose and this arm will be closed to new patient enrollment. An amendment to the trial protocol is planned to allow eligible patients in this arm to increase their dose to 9.4 mg/kg per investigator discretion.
- In the 9.4 mg/kg dosing arm, even though at the week 12 data assessment an insufficient number of patients met the protocol defined interim criteria, this arm warrants further investigation because encouraging trends in the efficacy data were observed. Patients already enrolled in this arm may continue to receive imetelstat. New enrollment in this arm will be suspended while the trial continues in order to obtain additional and more mature data that includes a longer follow-up of patients at 24 weeks, consistent with the co-primary efficacy endpoints. The number of patients enrolled to date is expected to be sufficient to inform potential future development of this dose.
- Janssen plans to conduct an additional internal data review in the second quarter of 2017 to include a longer follow-up of patients at 24 weeks. Potential outcomes of the second internal review at the 24-week time point could include resuming enrollment in the 9.4 mg/kg dosing arm, with or without changes to the dosing regimen; adding a new dosing arm; or closing the trial.
- Any protocol amendments will be subject to review by health authorities around the world.
Shares of Vitae Pharmaceuticals Inc (NASDAQ:VTAE) ended Friday session in green amid volatile trading. The shares closed up +0.11 points or 0.53% at $20.95 with 4.13 million shares getting traded. Post opening the session at $20.85, the shares hit an intraday low of $20.84 and an intraday high of $20.95 and the price vacillated in this range throughout the day. The company has a market cap of $607.41 million and the numbers of outstanding shares have been calculated to be 28.84 million shares.
Vitae Pharmaceuticals Inc (VTAE) on Aug. 10, 2016 announced the appointment of Scott Applebaum as General Counsel and Corporate Secretary, effective immediately. Mr. Applebaum most recently served as Chief Legal Officer and Corporate Secretary at Medgenics, Inc., a genomics medicine company focused on rare pediatric diseases.
“Scott’s extensive experience in providing legal and corporate compliance guidance will be invaluable to Vitae as our pipeline of first-in-class therapies continues to grow and advance,” said Jeff Hatfield, President and Chief Executive Officer of Vitae. “We are delighted to welcome Scott to the team.”
Mr. Applebaum brings to Vitae nearly 20 years of legal and regulatory experience gleaned from global leadership roles at small and large pharmaceutical companies, including 10 years at Shire in multiple regulatory affairs, corporate compliance and legal positions, from heading its Specialty Pharma Legal department, to heading its Global Regulatory Affairs department, and finally overseeing its Neuroscience Business Unit. Throughout his tenure at Shire, Mr. Applebaum provided counsel to the company’s executive leadership team on key corporate and regulatory compliance matters, in addition to supporting the company’s various acquisitions. Before Shire, he served as Senior Counsel at Bristol-Myers Squibb, where he instituted a U.S. compliance program for the company’s sales and marketing initiatives, in addition to providing legal counsel for the company’s commercial operations.
Mr. Applebaum earned his J.D. from Stanford University Law School, where he was a member of the Stanford Law Review. He graduated summa cum laude from The Wharton School of the University of Pennsylvania with a B.S. in economics with a concentration in accounting and finance.
“I am pleased to join Vitae as the company continues making strides in advancing novel and potentially difference-making therapies that have been developed with its proprietary structure-based drug design platform,” said Mr. Applebaum.