GlycoGenesys, Inc. Provides Update on Corporate and Clinical Plans Going Forward.BOSTON -- GlycoGenesys, Inc., (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : GLGS), a biotechnology company focused on carbohydrate-based drug development, provided a corporate update on its cancer clinical trial programs for GCS-100, its pipeline expansion strategy and the expected timelines for its drug development programs. SUMMARY Today the Company announced: --The addition of a site to its initiated Phase I/II multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility trial; --Plans for its Phase I/II clinical trial in chronic lymphocytic leukemia chronic lymphocytic leukemia n. Abbr. CLL Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. (CLL CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ); --A more detailed clinical development plan and timelines for GCS-100 in solid tumors and bloodborne cancers; --Efforts to establish a long-term funding relationship in 2005 to help fund its clinical trial programs and pipeline expansion UPDATE ON 2005 GCS-100 CANCER PROGRAM The Company's clinical program positions it to pursue approval in two indications for unmet medical needs in cancer (multiple myeloma and CLL) and starts the international regulatory process for GCS-100. This is in addition to the Company's continuing solid tumor program. The Company may also choose to apply for Fast Track designation in the U.S. for one or both bloodborne indications in the future. Solid Tumors GlycoGenesys' Phase I dose escalation trial for patients with advanced-stage solid tumors is enrolling patients at the sixth dose level (200mg/meter squared) planned under the protocol. This trial is currently being conducted at three clinical sites: Sharp Memorial Hospital, Clinical Oncology Research, in San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. , the Arizona Cancer Center in Tucson, Arizona Tucson (pronounced /ˈtusɑn/, Spanish: Tucsón [tuk'son] and the Arizona Cancer Center - Greater Phoenix Area in Scottsdale, Arizona Scottsdale (O'odham Vaṣai S-vaṣonĭ) is a city in Maricopa County, Arizona, United States, adjacent to Phoenix. Scottsdale has become internationally recognized as a premier and posh tourist destination, while maintaining its own identity and culture as " . The Company plans to disclose preliminary results from this trial later this month. A Phase II trial for treatment of solid tumors is planned for initiation in the second quarter of 2006. The study will be designed with the assistance of the Company's experienced Scientific Advisory Board. Preclinical efficacy studies, pharmacokinetic analyses and tumor assessment data from the current Phase I study will be carefully considered to determine the specific tumor types, dosing regimen and likely combination therapy strategy. If results of the Phase II trial are supportive, the Company plans to initiate a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trial in the fourth quarter of 2007. Multiple Myeloma In collaboration with Dr. Kenneth Anderson Ken or Kenneth Anderson may refer to:
in vi·tro adj. In an artificial environment outside a living organism. tests have shown GCS-100 in combination with dexamethasone to have an additive effect additive effect n. An effect in which two substances or actions used in combination produce a total effect the same as the sum of the individual effects. allowing for lower dose levels of both GCS-100 and dexamethasone to be used. The trial was initiated at the Dana-Farber in April 2005 and is enrolling patients. The Company recently initiated a second clinical site, the Lucy Curci Cancer Center in Rancho Mirage, California Rancho Mirage is a city in Riverside County, California, United States. The population was 13,249 at the 2000 census, but the seasonal (part-time) population can exceed 20,000. . It anticipates adding three more sites to expedite patient enrollment of the trial. The Company's clinical trial timeline calls for this trial to be completed in the third quarter of 2006. Assuming favorable data in the Phase I/II trial, a Phase II study is planned to begin in the third quarter of 2006 and be completed in the first quarter of 2008. This study will be designed to enable the Company to expand to a pivotal trial if supported by an interim review of the data. If needed to demonstrate clinical significance, a Phase III trial is planned for initiation in the third quarter of 2008. Chronic Lymphocytic Leukemia (CLL) The Company is pursuing CLL as an indication based on promising preclinical data including a new discovery recently presented at the prestigious 9th International Conference on Malignant Lymphoma malignant lymphoma n. See lymphoma. by Dr. Finbarr Cotter cot·ter n. 1. A bolt, wedge, key, or pin inserted through a slot in order to hold parts together. 2. A cotter pin. [Origin unknown. of Barts Medical School in London. The first CLL clinical trial is planned to begin in the third quarter of 2005 in the U.S. with sites in the United Kingdom to follow. The protocol for this study was written in collaboration with Dr. Finbarr Cotter, Dr. Jennifer Brown, Dana-Farber Cancer Institute and Dr. Archie Prentice, Chairman British Committee for Standards in Haematology. The Company anticipates this trial will be completed in the third quarter of 2006. Pending review of the data, a pivotal Phase II/III study may be designed. This Phase II/III trial is projected to be initiated in the fourth quarter of 2006 with enrollment expected to be completed in early 2008. PIPELINE EXPANSION The Company is working to expand its pipeline by leveraging the potential of GCS- 100 and its analogs and by in-licensing with the goal of filing three new INDs by early 2007. Utilizing its lab in Cambridge Massachusetts the Company is conducting research on developing an orally administered version of GCS-100 and plans to file an IND for an oral formulation of GCS-100 in the third quarter of 2006. In addition, GCS-100 has shown activity in the area of angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. and the Company was recently granted a patent on its use to control angiogenesis. The Company plans to work on analogs of GCS-100 in diseases in which angiogenesis plays a role with the goal of filing an IND for a non-oncology indication in the first quarter of 2007. The Company intends to out-license this analog. Finally, the Company is seeking to in-license an oncology compound with the goal of filing an IND on this compound in the first quarter of 2007. COMMITTED TO ESTABLISHING A LONG-TERM FUNDING RELATIONSHIP IN 2005 The breadth of the Company's current trials as well as its clinical trial and pipeline plans warrant consummating a strategic funding during 2005. The Company is actively pursuing a dual track: a partnership with another pharmaceutical or biotech company, or a relationship with fundamental, long-term investors, either of which will provide long-term funding. The Company believes a strategic funding would likely benefit shareholder value, further validate its technology, and provide additional resources to conduct an expanded clinical trial program and develop its pipeline. The clinical trials planned to begin later in 2005 and pipeline development will be undertaken in conjunction with a strategic funding. The timing and/or success of these efforts cannot be predicted or assured but the Company is committed to achieving this goal expeditiously ex·pe·di·tious adj. Acting or done with speed and efficiency. See Synonyms at fast1. ex . About GlycoGenesys, Inc. GlycoGenesys, Inc. is a biotechnology company that develops and licenses compounds based on glycobiology. The Company's drug candidate GCS-100, a unique compound to treat cancer, has been evaluated in previous clinical trials at low dose levels in patients with colorectal, pancreatic and other solid tumors with stable disease and partial response documented. The Company currently is conducting a Phase I dose escalation trial to evaluate higher dose levels of GCS-100LE, a low ethanol formulation of GCS-100, at Sharp Memorial Hospital, Clinical Oncology Research in San Diego, California and the Arizona Cancer Center in both Tucson and Scottsdale, Arizona. In addition, GCS-100LE is being evaluated in a Phase I/II trial for multiple myeloma. Further clinical trials are planned for 2005, 2006 and 2007. Further information is available on GlycoGenesys' web site: www.glycogenesys.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Any statements contained in this release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including, but not limited to, risks of product development (such as failure to demonstrate efficacy or safety), risk related to FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and other regulatory procedures, market acceptance risks, the impact of competitive products and pricing, the results of current and future licensing, joint ventures and other collaborative relationships, risks relating to raising sufficient capital to fund the Company's operations, developments regarding intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , and other risks identified in the Company's Securities and Exchange Commission filings. Actual results, events or performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. |
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