Genta Appoints Loretta M. Itri, M.D. as Executive Vice President for Clinical Research and Development

Apr 04, 2001, 01:00 ET from Genta Incorporated

    BERKELEY HEIGHTS, N.J., April 4 /PRNewswire/ -- Genta Incorporated
 (Nasdaq:   GNTA) announced the appointment of one of the pharmaceutical
 industry's 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 Company's
 clinical programs, including the Phase 3 program with Genta's leading
 investigational drug product (Genasense(TM)), substantial portions of the
 Company's planned New Drug Applications (NDAs), early clinical development of
 Genta's 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&J's R.W. Johnson Pharmaceutical Research Institute (PRI), she led the
 clinical teams responsible for NDA approvals for Procrit(TM), that company's
 largest single product drug, which currently exceeds $2.5 billion in global
 revenues. She had similar leadership responsibilities for the approvals of
 Leustatin(TM), Renova(TM), Topamax(TM), Levofloxin(TM), and Ultram(TM). 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 (Roferon(TM); interferon
 alfa). Annual worldwide sales of recombinant interferons currently exceed
 $3 billion. (Dr. Itri's 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
 Genta's 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 industry's 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, Genasense(TM) can become the industry's 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."
     Genta Incorporated is a biopharmaceutical company with a diversified
 product portfolio that is focused on anticancer therapy. The research platform
 is anchored by antisense technology. Genasense(TM), the Company's lead
 compound, has received "Fast Track" and "Orphan Drug" designation from the
 Food and Drug Administration. Genasense(TM) is currently in several Phase 3
 clinical trials. Genta's product pipeline also comprises a portfolio of small
 molecules, including gallium-containing compounds for treatment of diseases
 associated with accelerated bone loss, and Androgenics compounds for prostate
 cancer. Genta aims to become a direct marketer of its pharmaceutical products
 in the United States. For more information about Genta, please visit the
 Company's website at: http://www.genta.com.
 
     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 Procrit(TM), Orthoclone(TM), and Leustatin(TM). She was also
 responsible for the company's 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&J's 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 Renova(TM) (dermatologic), Topamax(TM) (anti-epileptic),
 Ultram(TM) (antibiotic), Levofloxin(TM) (antibiotic), and Tramadol(TM)
 (analgesic), as well as CPMP (European) submissions for Eprex(TM) (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 Procrit(TM) (for chemotherapy-induced
 anemia and other indications) and Leustatin(TM) (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
 company's 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 FDA's Advisory Collaboration on
 Drug Development Improvement (1997), the National Cancer Institute's Board's
 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
 Director's 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 President's 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.
 
     The statements contained in this press release that are not historical are
 forward-looking statements within the meaning of Section 27A of the Securities
 Act of 1933, as amended, and Section 21E of the Securities Exchange Act of
 1934, as amended, including statements regarding the expectations, beliefs,
 intentions or strategies regarding the future. Without limiting the foregoing,
 the words "anticipates," "believes," "expects," "intends," "may" and "plans"
 and similar expressions are intended to identify forward-looking statements.
 The Company intends that all forward-looking statements be subject to the safe
 harbor provisions of the Private Securities Litigation Reform Act of 1995.
 These forward-looking statements reflect the Company's views as of the date
 they are made with respect to future events, but are subject to many risks and
 uncertainties, which could cause the actual results of the Company to differ
 materially from any future results expressed or implied by such
 forward-looking statements. For example, the results obtained in pre-clinical
 or clinical studies may not be indicative of results that will be obtained in
 future clinical trials, and delays in the initiation or completion of clinical
 trials may occur as a result of many factors. Further examples of such risks
 and uncertainties also include, but are not limited to: the obtaining of
 sufficient financing to maintain the Company's planned operations; timely
 development, receipt of necessary regulatory approvals, and acceptance of new
 products; the successful application of the Company's technology to produce
 new products; the obtaining of proprietary protection for any such technology
 and products; the impact of competitive products and pricing and reimbursement
 policies; and changing market conditions. The Company does not undertake to
 update forward-looking statements. Although the Company believes that the
 forward-looking statements contained herein are reasonable, it can give no
 assurances that the Company's expectations are correct. All forward-looking
 statements are expressly qualified in their entirety by this cautionary
 statement and other factors detailed in the Company's reports filed with the
 Securities and Exchange Commission.
 
 

SOURCE Genta Incorporated
    BERKELEY HEIGHTS, N.J., April 4 /PRNewswire/ -- Genta Incorporated
 (Nasdaq:   GNTA) announced the appointment of one of the pharmaceutical
 industry's 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 Company's
 clinical programs, including the Phase 3 program with Genta's leading
 investigational drug product (Genasense(TM)), substantial portions of the
 Company's planned New Drug Applications (NDAs), early clinical development of
 Genta's 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&J's R.W. Johnson Pharmaceutical Research Institute (PRI), she led the
 clinical teams responsible for NDA approvals for Procrit(TM), that company's
 largest single product drug, which currently exceeds $2.5 billion in global
 revenues. She had similar leadership responsibilities for the approvals of
 Leustatin(TM), Renova(TM), Topamax(TM), Levofloxin(TM), and Ultram(TM). 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 (Roferon(TM); interferon
 alfa). Annual worldwide sales of recombinant interferons currently exceed
 $3 billion. (Dr. Itri's 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
 Genta's 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 industry's 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, Genasense(TM) can become the industry's 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."
     Genta Incorporated is a biopharmaceutical company with a diversified
 product portfolio that is focused on anticancer therapy. The research platform
 is anchored by antisense technology. Genasense(TM), the Company's lead
 compound, has received "Fast Track" and "Orphan Drug" designation from the
 Food and Drug Administration. Genasense(TM) is currently in several Phase 3
 clinical trials. Genta's product pipeline also comprises a portfolio of small
 molecules, including gallium-containing compounds for treatment of diseases
 associated with accelerated bone loss, and Androgenics compounds for prostate
 cancer. Genta aims to become a direct marketer of its pharmaceutical products
 in the United States. For more information about Genta, please visit the
 Company's website at: http://www.genta.com.
 
     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 Procrit(TM), Orthoclone(TM), and Leustatin(TM). She was also
 responsible for the company's 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&J's 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 Renova(TM) (dermatologic), Topamax(TM) (anti-epileptic),
 Ultram(TM) (antibiotic), Levofloxin(TM) (antibiotic), and Tramadol(TM)
 (analgesic), as well as CPMP (European) submissions for Eprex(TM) (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 Procrit(TM) (for chemotherapy-induced
 anemia and other indications) and Leustatin(TM) (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
 company's 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 FDA's Advisory Collaboration on
 Drug Development Improvement (1997), the National Cancer Institute's Board's
 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
 Director's 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 President's 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.
 
     The statements contained in this press release that are not historical are
 forward-looking statements within the meaning of Section 27A of the Securities
 Act of 1933, as amended, and Section 21E of the Securities Exchange Act of
 1934, as amended, including statements regarding the expectations, beliefs,
 intentions or strategies regarding the future. Without limiting the foregoing,
 the words "anticipates," "believes," "expects," "intends," "may" and "plans"
 and similar expressions are intended to identify forward-looking statements.
 The Company intends that all forward-looking statements be subject to the safe
 harbor provisions of the Private Securities Litigation Reform Act of 1995.
 These forward-looking statements reflect the Company's views as of the date
 they are made with respect to future events, but are subject to many risks and
 uncertainties, which could cause the actual results of the Company to differ
 materially from any future results expressed or implied by such
 forward-looking statements. For example, the results obtained in pre-clinical
 or clinical studies may not be indicative of results that will be obtained in
 future clinical trials, and delays in the initiation or completion of clinical
 trials may occur as a result of many factors. Further examples of such risks
 and uncertainties also include, but are not limited to: the obtaining of
 sufficient financing to maintain the Company's planned operations; timely
 development, receipt of necessary regulatory approvals, and acceptance of new
 products; the successful application of the Company's technology to produce
 new products; the obtaining of proprietary protection for any such technology
 and products; the impact of competitive products and pricing and reimbursement
 policies; and changing market conditions. The Company does not undertake to
 update forward-looking statements. Although the Company believes that the
 forward-looking statements contained herein are reasonable, it can give no
 assurances that the Company's expectations are correct. All forward-looking
 statements are expressly qualified in their entirety by this cautionary
 statement and other factors detailed in the Company's reports filed with the
 Securities and Exchange Commission.
 
 SOURCE  Genta Incorporated