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Biotech / Medical : GlycoGenesys GLGS (formerly SafeScience SAFS) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (41)	8/8/2005 4:03:47 PM
From: tuck	Read Replies (1) \| Respond to of 56

Corporate update: >>BOSTON--(BUSINESS WIRE)--Aug. 8, 2005--GlycoGenesys, Inc., (NASDAQ: GLGS - News), 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 trial; Plans for its Phase I/II clinical trial in chronic lymphocytic leukemia (CLL); 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, the Arizona Cancer Center in Tucson, Arizona and the Arizona Cancer Center - Greater Phoenix Area in Scottsdale, Arizona. 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 trial in the fourth quarter of 2007. Multiple Myeloma In collaboration with Dr. Kenneth Anderson and Dr. Paul Richardson of the Dana- Farber Cancer Institute, the Company designed a Phase I/II trial to study GCS- 100 in patients with relapsed or refractory multiple myeloma both alone and in combination with dexamethasone, a standard chemotherapy in multiple myeloma. This is the first clinical trial combining GCS-100 with another therapy. Dexamethasone was chosen because in vitro tests have shown GCS-100 in combination with dexamethasone to have an additive effect 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. 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 by Dr. Finbarr Cotter 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 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. << snip Cheers, Tuck

To: tuck who wrote (41)	12/5/2005 1:42:01 PM
From: tuck	Read Replies (1) \| Respond to of 56

[Phosphorylation of Galectin-3 Contributes to Malignant Transformation of Human Epithelial Cells via Modulation of Unique Sets of Genes] >>Cancer Research 65, 10767-10775, December 1, 2005 Phosphorylation of Galectin-3 Contributes to Malignant Transformation of Human Epithelial Cells via Modulation of Unique Sets of Genes Nachman Mazurek1, Yun Jie Sun1, Janet E. Price2, Latha Ramdas3, Wendy Schober4, Pratima Nangia-Makker5, James C. Byrd1, Avraham Raz5 and Robert S. Bresalier1 Departments of 1 Gastrointestinal Medicine and Nutrition, 2 Cancer Biology, 3 Experimental Radiation Oncology, and 4 Blood and Marrow Transplantation, The University of Texas M.D. Anderson Cancer Center, Houston, Texas and 5 The Tumor Progression and Metastasis Program, Karmanos Cancer Institute, Wayne State University, Detroit, Michigan Requests for reprints: Robert S. Bresalier, Department of Gastrointestinal Medicine and Nutrition, The University of Texas M.D. Anderson Cancer Center, Unit 436, 1515 Holcombe Boulevard, Houston, TX 77030. Phone: 713-745-4340; Fax: 713-745-9295; E-mail: rbresali@mdanderson.org. Galectin-3 is a multifunctional ß-galactoside-binding protein implicated in apoptosis, malignant transformation, and tumor progression. The mechanisms by which galectin-3 contributes to malignant progression are not fully understood. In this study, we found that the introduction of wild-type galectin-3 into nontumorigenic, galectin-3-null BT549 human breast epithelial cells conferred tumorigenicity and metastatic potential in nude mice, and that galectin-3 expressed by the cells was phosphorylated. In contrast, BT549 cells expressing galectin-3 incapable of being phosphorylated (Ser6Glu Ser6Ala) were nontumorigenic. A microarray analysis of 10,000 human genes, comparing BT549 transfectants expressing wild-type and those expressing phosphomutant galectin-3, identified 188 genes that were differentially expressed (>2.5-fold). Genes affected by introduction of wild-type phosphorylated but not phosphomutant galectin-3 included those involved in oxidative stress, a novel noncaspase lysosomal apoptotic pathway, cell cycle regulation, transcriptional activation, cytoskeleton remodeling, cell adhesion, and tumor invasion. The reliability of the microarray data was validated by real-time reverse transcription-PCR (RT-PCR) and by Western blot analysis, and clinical relevance was evaluated by real-time RT-PCR screening of a panel of matched pairs of breast tumors. Differentially regulated genes in breast cancers that are also predicted to be associated with phospho-galectin-3 in transformed BT549 cells include C-type lectin 2, insulin-like growth factor-binding protein 5, cathepsins L2, and cyclin D1. These data show the functional diversity of galectin-3 and suggest that phosphorylation of the protein is necessary for regulation (directly or indirectly) of unique sets of genes that play a role in malignant transformation. << Cheers, Tuck