Geron Appoints Vice President, Pharmacovigilance and Drug Safety
January 17 2019 - 8:00AM
Geron Corporation (Nasdaq: GERN) today announced the hiring of the
first of several key leadership positions as it rebuilds the
in-house development team to support its plans to initiate a Phase
3 clinical trial of imetelstat in lower risk myelodysplastic
syndromes by mid-year 2019.
Israel Gutierrez, M.D., has joined the Company as Vice
President, Pharmacovigilance and Drug Safety, as of January 16,
2019. Dr. Gutierrez will lead and direct the oversight of clinical
drug safety risk management and compliance at Geron and will be
responsible for product safety-related recommendations and
decisions. Additionally, he will be responsible for ensuring
compliance for all current and planned imetelstat clinical trials
in accordance with domestic and international requirements for drug
safety oversight and reporting from late-stage development through
commercialization. As the senior pharmacovigilance expert, Dr.
Gutierrez will lead and oversee pharmacovigilance signal detection
and risk management activities and risk mitigation strategies, as
well as represent medical safety at all meetings with regulatory
authorities.
Dr. Gutierrez has more than 20 years of experience in clinical
development and a deep knowledge of data collection/monitoring,
signal detection, risk management and benefit-risk quantification
and assessment, with expertise in both pre- and post-registration
settings, including multiple product approvals. Most recently, he
was the President of Innovation and Co-founder of Clindatum, LLC, a
consulting firm focused on the clinical development of small
molecules, biologics and devices. Prior to that, Dr. Gutierrez was
Senior Director, Drug Safety and Pharmacovigilance at Pharmacyclics
and a member of the hematology-oncology development team. Dr.
Gutierrez has also been part of the oncology development teams at
Exelixis, Inc., Genentech, a member of the Roche Group, and Celgene
Corporation. Before a career in clinical development, he was a
clinical research scientist at Loma Linda University in Loma Linda,
California. Dr. Gutierrez has a B.S. in Biology from Cervantes
College in Jalisco, Mexico and an M.D. from Universidad Autonoma de
Guadalajara, Jalisco, Mexico.
In connection with the commencement of his employment with the
Company, the Company granted Dr. Gutierrez a non-statutory stock
option to purchase 400,000 shares of Geron common stock on January
16, 2019 at an exercise price of $1.09 per share, which is equal to
the closing price of Geron common stock on the date of grant. The
stock option has a 10-year term and vests over four years, with
12.5% of the shares underlying the option vesting on the six-month
anniversary of commencement of employment and the remaining shares
vesting over the following 42 months in equal installments of whole
shares, subject to Dr. Gutierrez’s continued employment with Geron.
The option was granted as a material inducement to employment in
accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to
the terms and conditions of a stock option agreement covering the
grant and Geron’s 2018 Inducement Award Plan, which was adopted
December 14, 2018 and provides for the granting of stock options to
new employees.
About Geron
Geron is a clinical stage biopharmaceutical company focused on
the development and potential commercialization of 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 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 that the Phase 3
clinical trial in lower risk myelodysplastic syndromes will begin
by mid-year 2019 and 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, risks
and uncertainties related to: (i) whether regulatory authorities
permit the further development of imetelstat on a timely basis, or
at all, to enable patient screening and enrollment of the Phase 3
clinical trial in lower risk myelodysplastic syndromes to
begin by mid-year 2019; (ii) whether imetelstat is safe and
efficacious, and whether any past or future efficacy or safety
results may cause the benefit-risk profile of imetelstat to become
unacceptable; and (iii) whether the transition of the imetelstat
program from Janssen Biotech, Inc. to the Company proceeds on a
timely basis to enable the Phase 3 clinical trial in lower risk
myelodysplastic syndromes to begin by mid-year
2019. Additional 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,” including Geron’s
quarterly report on Form 10-Q for the quarter ended September
30, 2018. 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.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
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