BERKELEY HEIGHTS, NJ, April 4, 2001
- Genta Incorporated (Nasdaq: GNTA) announced the appointment of
one of the pharmaceutical industrys leaders, Dr. Loretta M. Itri,
to the positions of Executive Vice-President, Clinical Research and
Development, and Chief Medical Officer. Dr. Itri will immediately
assume responsibility for all of the Companys clinical programs,
including the Phase 3 program with Gentas leading investigational
drug product (Genasense
TM
), substantial portions of the Companys planned New Drug
Applications (NDAs), early clinical development of Gentas
Androgenics program for prostate cancer, and Phase 4
activities.
Most recently, Dr. Itri was Senior Vice-President, Worldwide
Clinical Affairs, and Chief Medical Officer at Ortho Biotech Inc, a
Johnson & Johnson company. As the senior clinical leader at
Ortho Biotech and previously at J&Js R.W. Johnson
Pharmaceutical Research Institute (PRI), she led the clinical teams
responsible for NDA approvals for Procritä, that companys
largest single product drug, which currently exceeds $2.5 billion
in global revenues. She had similar leadership responsibilities for
the approvals of Leustatinä, Renovaä,
Topamaxä, Levofloxinä, and Ultramä.
Prior to joining J&J, Dr. Itri was associated with Hoffmann
LaRoche, Inc., most recently as Assistant Vice -President and
Senior Director of Clinical Investigations, where she was
responsible for all phases of clinical programs in Immunology,
Infectious Diseases, Antivirals, AIDS, Hematology, and Oncology.
Under her leadership in the areas of recombinant proteins,
cytotoxic drugs and differentiation agents, she compiled the first
successful Product License Application (PLA) for any interferon
product (Roferonä; interferon alfa). Annual worldwide
sales of recombinant interferons currently exceed $3 billion. (Dr.
Itris bio sketch appears below.)
"Dr. Itri has an unequaled track record of outstanding
accomplishments in drug development over her career", noted Dr.
Daniel D. Von Hoff, a member of Gentas Board of Directors and
Director of the Arizona Cancer Center. "As an individual, she has
built teams at several companies that have probably been
responsible for more NDA approvals in oncology/hematology that
anyone else in the industry. Between the Board and its senior
leaders, Genta has assembled one of the industrys top teams in
clinical oncology research."
Dr. Itri commented: "Within a very short period, Genta has
emerged as a leader in biotechnology. With the successful
completion of its clinical development program, Genasenseä
can become the industrys next blockbuster product in oncology. As a
drug that enhances rather than competes with other companies
anticancer products, I anticipate leveraging my extensive
relationships in the biotechnology and pharmaceutical sectors in
order to aggressively maximize this opportunity."
Biographical Sketch for Loretta M. Itri:
From 1990 until the present, Dr. Itri was associated with
Johnson & Johnson, most recently as Senior Vice-President for
Worldwide Clinical Affairs, Chief Medical Officer, and member of
the Board of Directors at Ortho Biotech, Inc. In this role, she
was responsible for Phase 3 and Phase 4 clinical development for
oncology, hematology, and immunology product lines, including
Procritä, Orthocloneä, and Leustatinä.
She was also responsible for the companys reorganization of its
development programs and for clinical relationships related to
New Product Development, Sales, and Marketing. From 1993 to 1995,
she was Vice-President for Medical and Regulatory Affairs at
J&Js R.W. Johnson Pharmaceutical Research Institute. In this
position, she was responsible for Clinical Research &
Development (managing groups in Hematology/Oncology, CNS,
Infectious Diseases, Immunology, Dermatology, and OB/GYN), as
well as Regulatory Affairs, Statistics, Data Management, and
Central Safety and Drug Surveillance. Managing a staff of more
than 400 and an annual budget in excess of $70 million, she
directed NDA and PLA submissions for Renovaä
(dermatologic), Topamaxä (anti-epileptic),
Ultramä (antibiotic), Levofloxinä (antibiotic),
and Tramadolä (analgesic), as well as CPMP (European)
submissions for Eprexä (epoetin alfa) and other drugs.
From 1992 to 1993, she was Vice-President for Biotechnology
Research and Development at PRI and a member of the Board of
Directors at both PRI and Ortho Biotech Inc. In this position,
she oversaw the first successful NDA submissions for
Procritä (for chemotherapy-induced anemia and other
indications) and Leustatinä (for hairy cell leukemia).
From 1990 to 1991, she was Vice-President for Clinical Research
at PRI responsible for the scientific direction of Phase 1-3
clinical studies in 8 therapeutic areas.
From 1981 to 1990, Dr. Itri was associated with Hoffmann
LaRoche in areas of increasing responsibility, most recently as
Assistant Vice-President and Senior Director of Clinical
Investigation. In that role, she supervised a staff of 85
employees and was in charge of all phases of clinical development
in Oncology, Hematology, Infectious Diseases, Antivirals, AIDS,
and Immunology. During her tenure at Roche, she acted as clinical
liaison to the companys Marketing Board and Licensing Committee
and represented the company in media and public relations related
to clinical research, biotechnology, and academic/industrial
relations.
Dr. Itri attended New York University, graduated Magna
cum Laude from Long Island University (B.S., biology), and
received a M.D. from New York Medical College. She completed her
residency in Internal Medicine at SUNY-Stony Brook Hospitals and
her oncology fellowship at Memorial Sloan-Kettering Cancer Center
in New York, where she was also a Clinical Instructor at Cornell
University Medical College. She has served on FDAs Advisory
Collaboration on Drug Development Improvement (1997), the
National Cancer Institutes Boards of Scientific Counselors for
the Division of Cancer Treatment (1990-1994) and the Division of
Cancer Prevention and Control (1982-1985), as well as the NCI
Directors Cancer Clinical Trials Advisory Board (1986-1994).
Among numerous awards, she was recently honored by the American
Cancer Society (1997) and the Mount Sinai School of Medicine for
contributions to breast cancer research (1998). She has also
received the J&J Presidents Cup for Outstanding Achievement,
the Tribute to Women in Industry (TWIN) Award, and the Phi Sigma
Award for Biological Research. Dr. Itri is an emeritus member of
the American Federation for Clinical Research and a Fellow of the
American College of Physician.
