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Wednesday, 06/27/2001 2:47:49 PM

Wednesday, June 27, 2001 2:47:49 PM

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Genta's CEO Highlights Clinical Progress of Genasense(TM) and Intellectual Property Strength at Major Industry Forum

Wednesday June 27, 9:44 am Eastern Time
Press Release
SOURCE: Genta Incorporated

Genta's CEO Highlights Clinical Progress of Genasense(TM) and Intellectual Property Strength at Major Industry Forum

BERKELEY HEIGHTS, N.J., June 27 /PRNewswire/ -- Genta Incorporated (Nasdaq: GNTA - news) announced that its Chairman and Chief Executive Officer, Dr. Raymond P. Warrell, Jr., presented an overview of the Genasense(TM) clinical program and intellectual property status on Tuesday at the BIO 2001 Investor & Partnering Forum in San Diego, CA. The presentation also highlighted new clinical data that was presented on Sunday at the annual meeting of the European Hematology Association (EHA) in Frankfurt, Germany.

At the EHA meeting the Company presented preliminary evidence of single-agent activity from new studies in chronic lymphocytic leukemia (CLL). Several patients experienced marked reductions in circulating leukemia cells after treatment with Genasense(TM) alone. This result reaffirmed single-agent responses previously reported in patients with lymphoma who had also responded with improvements in circulating lymphoma cells. The data followed several lectures that were presented at the State-of-the-Science meeting sponsored by the National Cancer Institute two weeks ago, which showed that Bcl-2 is a critical factor for CLL cell survival that can be knocked out by Genasense(TM).

Dr. Warrell commented: ``While this CLL trial was primarily designed to support the pharmacokinetic and biokinetic portions of next year's planned New Drug Application (NDA), early clinical results have been quite positive. Obviously, this clinical activity as a single agent is very encouraging for our ongoing Phase 3 trial in CLL that uses Genasense(TM) in combination with other active drugs.'' In other comments, Dr. Warrell noted:

``Genta is alone among companies with antisense technology in having established the scientific ''proof-of principle`` for antisense therapy in humans: namely, consistent down-regulation of the target protein in tumors excised from patients treated systemically with Genasense(TM).''

``The senior management at Genta has enormous depth in oncology drug development, having pulled numerous products through the NDA process at other companies. Our senior sales and marketing personnel have broad experience in the launch and management of blockbuster products in this sector. Our senior clinicians are internationally prominent in their fields, and they retain deep connections with the opinion leaders in hematology and oncology. This depth of experience, combined with our technical expertise, provides us with a tremendous competitive advantage over other companies in this space.''

In response to a question regarding Genta's patent position on Genasense(TM) and any implications of a patent regarding RNAse H, Dr. Warrell noted: ``Genta's holds a solid patent position on Genasense(TM), which we believe does not infringe the valid claims of any other patents. Furthermore, due to the extensive prior art, the commissioner of the U.S. Patent Office ordered re-examination of the RNAse H patent in question last July. We believe that publicly available information indicates that all claims even remotely affecting Genasense(TM) were rejected and withdrawn some time ago. Lastly, Genta itself holds a considerable patent position in antisense, and we intend to aggressively assert our rights with other companies that practice this technology.''

The audio feed of this presentation can be retrieved at: http://www.informedinvestors.com/iif_forums/event.cfm?forumID=194

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on anticancer therapy. The research platform is anchored by oligonucleotide chemistry, particularly applications of 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 undergoing late-stage, Phase 3 clinical testing. Genta's pipeline also comprises a portfolio of small molecules, including gallium-containing compounds for treatment of diseases associated with accelerated bone loss, Androgenics compounds for prostate cancer, and Decoy Aptamers for broad anticancer use. Genta aims to become a direct marketer of its pharmaceutical products in the United States. For more information about Genta, please visit our 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 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




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