Genta's Chief Technical Officer Provides Clinical and Manufacturing Update as Keynote Speaker to Industry Conference
Apr 26, 2001, 01:00 ET from Genta Incorporated
BERKELEY HEIGHTS, N.J., April 26 /PRNewswire Interactive News Release/ -- Genta Incorporated (Nasdaq: GNTA) reported that Dr. Robert E. Klem, Vice-President and Chief Technical Officer, delivered the keynote address today at the TIDES Oligonucleotide and Peptide Technology Conference this morning in Tucson, AZ. In his presentation, Dr. Klem updated preclinical, clinical, and manufacturing issues regarding Genta's second and third generation oligonucleotide research programs, which encompass drugs that use both antisense and "decoy" mechanisms. Regarding the clinical program for Genasense(TM), Genta's lead antisense drug, Dr. Klem noted: "Patient accrual to our lead studies is strong, which reflects both high investigator enthusiasm and strong interest by the medical community. We continue to anticipate completing enrollment in the melanoma study later this year. Although I perceive that external interest has mostly focused on our melanoma trial, in fact our other lead programs may also conclude on roughly the same timeline. Thus, at this point, I believe our first NDA for Genasense(TM) -- which remains on track for filing during the first half of 2002 -- could be submitted from any one of our 'registration quality' programs." Regarding manufacturing issues, Dr. Klem observed: "In our clinical development program and looking forward to next year's anticipated launch of Genasense(TM), Genta is strongly advantaged by our strategic partnership with the Life Sciences group at Avecia Ltd., the world's largest manufacturer of such compounds. Manufacturing quality has been a key issue for FDA, and as the company with the first antisense product intended for systemic use, Genta has anticipated a high level of regulatory scrutiny. We are very pleased with the Avecia collaboration, and both parties remain committed to establishing the highest quality standards in our manufacturing processes of this product." Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on anticancer therapy. Genasense(TM), the Company's lead antisense compound, 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 their website at: http://www.genta.com. 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 lack of success or 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. MAKE YOUR OPINION COUNT -- Click Here http://tbutton.prnewswire.com/prn/11690X20932507
SOURCE Genta Incorporated
BERKELEY HEIGHTS, N.J., April 26 /PRNewswire Interactive News Release/ -- Genta Incorporated (Nasdaq: GNTA) reported that Dr. Robert E. Klem, Vice-President and Chief Technical Officer, delivered the keynote address today at the TIDES Oligonucleotide and Peptide Technology Conference this morning in Tucson, AZ. In his presentation, Dr. Klem updated preclinical, clinical, and manufacturing issues regarding Genta's second and third generation oligonucleotide research programs, which encompass drugs that use both antisense and "decoy" mechanisms. Regarding the clinical program for Genasense(TM), Genta's lead antisense drug, Dr. Klem noted: "Patient accrual to our lead studies is strong, which reflects both high investigator enthusiasm and strong interest by the medical community. We continue to anticipate completing enrollment in the melanoma study later this year. Although I perceive that external interest has mostly focused on our melanoma trial, in fact our other lead programs may also conclude on roughly the same timeline. Thus, at this point, I believe our first NDA for Genasense(TM) -- which remains on track for filing during the first half of 2002 -- could be submitted from any one of our 'registration quality' programs." Regarding manufacturing issues, Dr. Klem observed: "In our clinical development program and looking forward to next year's anticipated launch of Genasense(TM), Genta is strongly advantaged by our strategic partnership with the Life Sciences group at Avecia Ltd., the world's largest manufacturer of such compounds. Manufacturing quality has been a key issue for FDA, and as the company with the first antisense product intended for systemic use, Genta has anticipated a high level of regulatory scrutiny. We are very pleased with the Avecia collaboration, and both parties remain committed to establishing the highest quality standards in our manufacturing processes of this product." Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on anticancer therapy. Genasense(TM), the Company's lead antisense compound, 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 their website at: http://www.genta.com. 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 lack of success or 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. MAKE YOUR OPINION COUNT -- Click Here http://tbutton.prnewswire.com/prn/11690X20932507 SOURCE Genta Incorporated
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