| To: tuck who wrote (37) | 4/5/2005 5:48:47 PM | | From: tuck | | | | >>BOSTON--(BUSINESS WIRE)--April 5, 2005--GlycoGenesys, Inc. (NASDAQ:GLGS - News), a biotechnology company focused on carbohydrate drug development, today announced it recently initiated a Phase I/II dose escalation clinical trial of its cancer drug candidate GCS-100LE in patients with multiple myeloma, the second most common hematologic, or blood, cancer. The first trial site is the Dana-Farber Cancer Institute in Boston. The trial will be conducted under the direction of Dr. Kenneth C. Anderson and Dr. Paul Richardson, the Principal Investigator. Dr. Richardson is the Clinical Director of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute and an Assistant Professor of Medicine, Harvard Medical School. Dr. Anderson is the Chief, Division of Hematologic Neoplasia at the Dana-Farber Cancer Institute and the Kraft Family Professor of Medicine, Harvard Medical School.
Both Drs. Anderson and Richardson are world-leading experts in the research of treatments for multiple myeloma. Among several important clinical studies in multiple myeloma, Drs. Anderson and Richardson were intimately involved in pre- clinical testing, trial design and human clinical trials that led to the regulatory approval of Velcade® marketed by Millennium Pharmaceuticals and Johnson and Johnson for the treatment of multiple myeloma.
About The Clinical Trial
Patients will receive GCS-100LE as a monotherapy in treatment cycles of two doses of GCS-100LE per week for 2 weeks followed by one week off therapy. If patients progress after 2 cycles or remain stable after 4 cycles, dexamethasone, a standard therapy, may be added to their treatment. Patients showing a partial or complete response on GCS-100LE as a monotherapy or GCS-100LE in combination with dexamethasone will continue on such treatment. The combination of GCS- 100LE and dexamethasone has been shown pre-clinically to have an additive effect on the killing of multiple myeloma cells.
The primary objective of the Phase I/II dose escalation study is to evaluate the safety of GCS-100LE when given to patients with relapsed or refractory multiple myeloma and to identify the recommended dose for future studies. Secondary objectives are to evaluate the response to GCS-100LE as a monotherapy and in combination with dexamethasone and determine the pharmacokinetics of GCS-100LE alone and with dexamethasone.
"I'm excited to see this trial begin. Based on our preclinical work we believe there is promise for GCS-100 to have a positive effect on patients with multiple myeloma. We look forward to contributing to the development of GCS-100," stated Dr. Richardson.
Clinical Trial Strategy For Multiple Myeloma
A Phase II/III multiple myeloma trial is planned to follow this trial. The Company will work with clinical investigators and the FDA with the aim of designing this trial as a pivotal study, assuming the data supports it.
Scientific Rationale
The scientific rationale behind initiating this clinical trial is based on pre- clinical research conducted on GCS-100LE by Dr. Anderson and his colleagues at Dana-Farber's Jerome Lipper Multiple Myeloma Center. Under Dr. Anderson's direction, the Center's researchers have pioneered new pre-clinical models to evaluate the potential of new multiple myeloma drug candidates before they enter human clinical testing. Findings from their promising research on GCS-100LE were published in an abstract in Blood and presented during a poster session at the American Society of Hematology's 2004 Annual Meeting in December.
In pre-clinical studies GCS-100LE has been shown to:
Induce cell death in multiple myeloma cells without significant toxicity against normal white blood cells.
Directly target multiple myeloma cells while in the presence of protective bone marrow cells.
Trigger cell death in multiple myeloma cells resistant to commonly used anti- cancer agents including dexamethasone, melphalan, doxorubicin, and Velcade®.
Have additive and synergistic effects when combined with caspase-activating agents dexamethasone and PK11195, respectively.
These findings provide the framework for clinical evaluation of GCS-100LE either alone or in combination with dexamethasone or other therapies to overcome drug resistance and potentially improve patient outcome in multiple myeloma.
About Multiple Myeloma (MM)
Multiple myeloma is a bone marrow cancer in which white blood cells known as plasma cells, normally responsible for the production of infection-fighting antibodies, become abnormal and are overproduced. The proliferation of these abnormal plasma cells, called myeloma cells, results in decreased production of normal blood cells and disease-fighting antibodies. This proliferation causes growth of tumors that spread to multiple sites - hence the term multiple myeloma. The decreased white blood cell production weakens the immune system and decreased red blood cell production leads to fatigue and weakness, while the myeloma tumors cause bone destruction, pain and fractures.
MM is the second most common hematologic malignancy and although the disease is predominantly a cancer among older individuals (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and onset at a younger age. In the United States, more than 50,000 individuals have MM and over 14,600 new cases of the disease are diagnosed each year. Worldwide, there are approximately 74,000 new cases and over 45,000 deaths due to multiple myeloma each year.
About Dana-Farber and The Jerome Lipper Multiple Myeloma Center
Dana-Farber Cancer Institute is a principal teaching affiliate of Harvard Medical School, a federally designated Center for AIDS Research, and a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), a federally designated comprehensive cancer center. Providing advanced training in cancer treatment and research for an international faculty, the Institute conducts community-based programs in cancer prevention, detection, and control throughout New England, and maintains joint programs with other Boston institutions affiliated with Harvard Medical School and the Partners Health Care System, including Brigham & Women's Hospital, Children's Hospital, and Massachusetts General Hospital.
The Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute provides comprehensive, state-of-the-art care, including promising new therapies through clinical trials, to patients with multiple myeloma. In addition, the center conducts an active program of basic and clinical research aimed at improving the outcomes of patients with multiple myeloma. <<
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Good, but need some interim data, or some kind of results.
Cheers, Tuck |
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| To: tuck who wrote (38) | 5/4/2005 6:16:51 PM | | From: tuck | | | | Paid report by a Scimitar analyst:
scimitarequity.com
Calls it a buy. Yeah, maybe now that it's utterly cratered to the point that it again has listing issues.
An NDA in multiple myeloma by 2007? Seem a little ambitious to anyone? Apparently there's some work by Dana Farber people showing GLGS compound has promise in bortezomib-refractory MM, which is indeed interesting.
Cheers, Tuck |
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| To: tuck who wrote (39) | 5/4/2005 6:34:43 PM | | From: tuck | | | | Oh, right, there was a PR about all this, of course. The abstract:
>>[2456] Mitochondria and Caspase-Independent Cell-Death Triggered by GCS-100, a Novel Carbohydrate-Based Therapeutic in Multiple Myeloma (MM) Cells. Session Type: Poster Session 669-II
Dharminder Chauhan, Guilan Li, Klaus Podar, Teru Hideshima, Kenji Ishitsuka, Laurence Catley, Martin Sattler, Yu-Tzu Tai, Renate Burger, Paul Richardson, Yan Chang, Joanne Schindler, Bradley Carver, Kenneth C. Anderson (Intr. by Kenneth C. Anderson). Medical Oncology, Dana Farber Cancer Institute, Boston, MA, USA; GlycoGenesys, Inc, Boston, MA, USA
GCS-100 is a carbohydrate-based therapeutic in clinical development for the treatment of cancer. Here we show that GCS-100 directly targets MM cells and their bone marrow (BM) microenvironment. Treatment of various MM cell lines, including those resistant to conventional anti-MM agents such as, dexamethasone, melphalan, or doxorubicin, with GCS-100 triggers growth arrest and apoptosis. Examination of purified patient MM cells demonstrated similar results, without significant toxicity against normal peripheral blood mononuclear cells. Importantly, GCS-100 decreases viability of bortezomib-resistant MM patient cells. GCS-100 blocks MM cell growth induced by both adhesion to bone marrow stromal cells (BMSCs) and related cytokine secretion, thereby inhibiting growth and survival in MM cells conferred by the BM microenvironment. GCS-100 overcomes drug-resistance conferred by anti-apoptotic protein Bcl-2 and heat shock protein-27. Although GCS-100 induces MM cell death evidenced by morphological and DNA fragmentation analysis, no activation of caspases-8, -9 and -3 was noted at the IC50 dose. Conversely, the pan caspase inhibitor Z-VAD-fmk failed to abrogate GCS-100-induced apoptosis. Furthermore, GCS-100 does not alter mitochondrial membrane potential, suggesting a mitochondria- and caspase-independent cell death-signaling pathway. These data provided the rationale for combining GCS-100 with an agent that specifically triggers mitochondrial apoptotic signaling in MM cells. For example, combining a conventional agent dexamethasone, a known inducer of Smac release from mitochondria and activator of caspase-9/3 cascade, with GCS-100 shows additive anti-MM activity; and combining GCS-100 with an antagonist to mitochondrial peripheral benzodiazepine receptor PK-11195 shows synergistic anti-MM activity, associated with profound mitochondrial cell-death signaling and activation of caspase-9 and –3. Collectively, these findings lay the framework for clinical evaluation of GCS-100, either alone or in combination with dexamethasone or PK-11195, to overcome drug resistance and improve patient outcome in MM.
Abstract #2456 appears in Blood, Volume 104, issue 11, November 16, 2004<<
Cheers, Tuck |
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| To: tuck who wrote (40) | 6/15/2005 2:25:02 PM | | From: tuck | | | | [GCS-100 mechanism of apoptotic action, the sequel]
>>BOSTON--(BUSINESS WIRE)--June 15, 2005-- New Discovery Revealed At The 9th International Conference On Malignant Lymphoma in Lugano, Switzerland
GlycoGenesys, Inc. (Nasdaq: GLGS - News), a biotechnology company focused on carbohydrate-based drug development, today announced that Dr. Finbarr Cotter, Professor, Barts and The London Queen Mary's School of Medicine UK, revealed how GCS-100 targets cells from CLL patients and a variety of lymphoma cell lines to induce cell death. These new findings were presented recently at the prestigious 9th International Conference on Malignant Lymphoma. The presentation and a corresponding published abstract from the conference were entitled "GCS-100 A Novel Galectin-3 Antagonist and Caspace-9 Activating Therapy For Indolent B-Cell Malignancies."
To provide a context to understand the potential commercial implications of Dr. Cotter's research, we believe it is important to know that GlycoGenesys' cancer drug candidate GCS-100 has been shown to bind to Galectin-3. Also, earlier literature demonstrates that Galectin-3 and Bcl-2 are over-expressed in a variety of lymphomas and solid tumor cancers. Moreover, GCS-100 is the first Galectin-3 inhibitor now in clinical trials for the treatment of both bloodborne and solid tumor cancers.
With this background, a summary of the new scientific findings includes:
Dr. Cotter demonstrated for the first time that Galectin-3 and Bcl-2 are co- located in malignant cell lines;
That GCS-100 blocks Galectin-3's ability to co-locate with Bcl-2 in these malignant cell lines causing targeted cell death;
And, this programmed cell death occurs through the known caspase-9 mediated cell death pathway;
Moreover, GCS-100 induced significant programmed cell death in both malignant cell lines and primary patient CLL cells with minimal effect against normal B-cells and stem cells;
And, Dr. Cotter's new data strongly supports previously published research that Galectin-3 is a valid therapeutic target to treat cancer.
Dr. Cotter stated, "These findings provide a real insight into an exciting new agent for cancer therapy as well as a greater understanding of newly emerging cancer therapy targets, namely the galectins. I look forward to being involved as an advisor in the upcoming CLL trial and reporting additional research on GCS-100 at future meetings and in publications."
Bradley J Carver, the Company's CEO and President stated, "Dr. Cotter's findings tell us how GCS-100 targets and destroys malignant lymphoma and CLL cells with minimal effect against normal B-cells and stem cells. This information is very exciting as it supports our choice of CLL as the indication of our next clinical trial and will be helpful in our partnering discussions for GCS-100."
About the Presentation
Dr. Cotter's presentation focused on new scientific discoveries about lymphoma and chronic lymphocytic leukemia (CLL) cells and their potential therapeutic relevance to GlycoGenesys' cancer drug candidate GCS-100. In newly presented data, Dr. Cotter showed for the first time that Galectin-3 and Bcl-2 are co- located in malignant lymphoma cell lines. Further and importantly, his data demonstrated in vitro that GCS-100 induced targeted cancer cell death by blocking Galectin-3's ability to co-locate with Bcl-2 in these cell lines. Moreover, the data illustrated that GCS-100 induced cancer cell death in these patient cells and cell lines through caspase-9, a well known cancer cell death pathway.
Bcl-2 and Galectin-3 are known to protect cancer cells from dying. Published literature suggests that over expression of these survival proteins is often associated with chemotherapy resistance and/or poorer clinical outcomes for cancer patients. This new data on GCS-100 provides significantly more detail of its mechanism of action in selectively targeting and inducing cell death in lymphoma cells and CLL.
Dr. Cotter underscored his previously reported data illustrating GCS-100's ability to enhance the effect of existing chemotherapeutic agents, including etoposide. Another favorable attribute of GCS-100 discussed by Dr. Cotter is its lack of myelosuppression, a negative side effect of some widely used cancer treatments. Myelosuppression is a condition in which bone marrow activity is decreased resulting in fewer red blood cells, white blood cells and platelets.
About The Conference Abstract:
Annals of Oncology, Official Journal of The European Society for medical Oncology. Volume 16, 2005 Supplement 5.
Abstract # 111, GCS-100 A Novel Galectin-3 Antagonist and Caspace-9 Activating Therapy For Indolent B-Cell Malignancies<<
The stock has sunk so low that this is good for a 20% bounce. Imagine what kind of bounce we'd see on CLINICAL results.
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Cheers, Tuck |
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| To: tuck who wrote (41) | 8/8/2005 4:03:47 PM | | From: tuck | | | | 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. <<
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Cheers, Tuck |
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| To: Pogeu Mahone who wrote (43) | 8/17/2005 2:06:10 PM | | From: tuck | | | | Funding on almost any terms will help the share price. Enrolment seems very slow, though. They'll need a lot of funding to inlicense anything of value. Dunno. Progress so slow it still seems very early. They need good results and smart decision making. Asking a lot? My inclination would be to bail on any funding related spike and go into watch mode. In my case, bailing at this point wouldn't bring in proceeds worthy of the transaction costs, so I'll hold, but can't bring myself to buy more.
Don't know if anyone else is paying attention and has a different feel, but you could ask others who have posted here.
Cheers, Tuck |
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| To: tuck who wrote (44) | 9/8/2005 1:12:47 PM | | From: tuck | | | | Finally, some data, and it looks pretty decent.
>>BOSTON--(BUSINESS WIRE)--Sept. 8, 2005--GlycoGenesys, Inc., (NASDAQ: GLGS - News), a biotechnology company focused on carbohydrate-based drug development, provided an update on its ongoing Phase I trial evaluating GCS-100 in patients with solid tumors.
SUMMARY
Today the Company announced preliminary results from its ongoing Phase I clinical trial in advanced solid tumors:
Establishing a maximum tolerated dose for GCS-100 under the protocol;
Showing of the 14 patients for which response data is available, 11 have experienced periods of stable disease; and
Providing safety and pharmacokinetic data that supports the Company's bloodborne cancer programs.
Preliminary Results - Phase I Trial in Advanced Solid Tumors
This Phase I study is an open-label, multi-center clinical trial. The primary purpose of the study is to evaluate the safety and tolerability of escalating doses of GCS-100 in patients with advanced solid tumors to determine a maximum tolerated dose. Secondary objectives included evaluation of pharmacokinetics and response. Patients participating in the study had previously received multiple treatment regimens, including chemotherapy, immunotherapy, radiation or hormone therapy. Of note, this is the first clinical trial using the low ethanol formulation of GCS-100. This formulation has eliminated ethanol-related side effects, allowed shorter infusion times and made it possible to deliver higher quantities of drug.
The trial achieved its primary objective of establishing a maximum tolerated dose for this dosing regimen of five consecutive days of therapy followed by 2 weeks off. Preliminary safety results available for 17 of the 22 enrolled patients demonstrate that GCS-100 is well tolerated with low toxicity. The dose limiting toxicity of GCS-100 when given intravenously in this regimen was a rash. The rash was manageable with steroid therapy and did not preclude additional dosing cycles. The majority of the remaining adverse events reported to date have been mild and reversible.
The pharmacokinetics of GCS-100 was linear throughout all doses tested. The data indicates that GCS-100 can reach the serum levels sufficient to kill several types of solid tumors in laboratory studies. Furthermore, the pharmacokinetic data suggests that more convenient dosing regimens may be possible in future solid tumor trials.
Of the 22 patients that have been enrolled into the study to date, 4 continue to receive GCS-100. Preliminary response data is currently available for 14 patients. This data shows that 11 out of 14 patients have had periods of stable disease under RECIST criteria lasting from approximately 1.5 months to greater than 8 months. Notably, three of these patients achieved stable disease despite being non-responsive to any prior therapies.
The trial continues to enroll patients at the maximum tolerated dose at Sharp Memorial Hospital, Clinical Oncology Research, in San Diego, CA, and the Arizona Cancer Center in Tucson and Scottsdale, AZ.
Safety Data Supporting Bloodborne Cancer Indications
Review of preliminary safety data shows that GCS-100 is well-tolerated, and, unlike many traditional chemotherapies, GCS-100 was not associated with decreased white blood cell counts or nerve damage. These toxicities are common limitations of several current treatments for patients with multiple myeloma and CLL. A Phase I/II study investigating GCS-100 as a treatment for multiple myeloma was initiated at the Dana-Farber in April 2005. A Phase I/II trial in CLL is targeted for initiation by October.
John J. Grous, M.D., the Medical Monitor for this study stated, "In this trial, GCS-100 shows much less toxicity than traditional cytotoxic chemotherapies. Most of the patients assessed so far achieved disease stabilization while on GCS-100 therapy. Notably, three of these patients achieved stable disease despite being non-responsive to any prior traditional or biologic chemotherapies. I look forward to the final results of the study as four patients are continuing on GCS-100 at this time." Dr. Grous continued, "GCS-100 is emerging as a valid targeted drug candidate against galectin-3, which has been shown preclinically to be involved in angiogenesis, metastasis, and apoptosis."
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 at the Dana-Farber Cancer Institute in Boston, Massachusetts and the Lucy Curci Cancer Center in Rancho Mirage, California. Further clinical trials are planned for 2005, 2006 and 2007. Further information is available on GlycoGenesys' web site: www.glycogenesys.com. <<
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OK, so stable disease doesn't mean much, but the PK and safety profile look pretty nice. If they fail to get PRs or CRs in PII, then I'll give up.
Cheers, Tuck |
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| To: tuck who wrote (45) | 9/9/2005 9:22:46 AM | | From: Findit | | | | GLGS - Scimitar is initiating a “BUY’ of GlycoGenesys, Inc. (GLGS: NASDAQ). We project a FY05 target
price of $2.25 for GLGS’s stock. If collaboration is consummated by the end of 2005 with a
major pharmaceutical or biotechnology company to develop and commercialize GLGS’s GCS-
100 compounds, then our FY06 target price would be upgraded to $3.50 – 4.00. |
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| To: Findit who wrote (46) | 9/16/2005 3:03:19 PM | | From: tuck | | | | >>BOSTON--(BUSINESS WIRE)--Sept. 16, 2005-- GlycoGenesys, Inc. (NASDAQ:GLGS - News), a biotechnology company, today announced the publication of an in-depth article introducing new and exciting in vitro findings about the Company's cancer drug candidate GCS-100. The paper was authored by Dr. Kenneth C. Anderson and researchers at the Dana-Farber Cancer Institute in collaboration with GlycoGenesys employees. It appeared in the American Association of Cancer Researcher's publication Cancer Research, September 15, 2005; Vol. 65, No.18 edition.
To provide the context to understand the potential commercial implications of these new findings, it is important to know that GlycoGenesys' cancer drug candidate GCS-100 has been shown to bind to Galectin-3. Galectin-3 is over-expressed in a variety of cancers including multiple myeloma, as well as solid tumors. Galectin-3 is a protein that protects cancer cells from dying. Notably, GCS-100 is currently in clinical testing for the treatment of multiple myeloma and solid tumors.
With this as a background, this new in vitro data generated at the Dana-Farber Cancer Institute illustrates for the first time that GCS- 100 decreases Galectin-3 expression in multiple myeloma cells when tested in combination with dexamethasone (a drug frequently used to treat multiple myeloma). These findings further showed that decreased Galectin-3 expression correlates with increased anti-tumor activity. This data adds to the understanding of how GCS-100 works in killing multiple myeloma cells.
The following additional findings show that GCS-100 has the potential to selectively kill and inhibit the growth of multiple myeloma cells, including drug-resistant cells, as well as prevent metastasis in patients with multiple myeloma:
GCS-100 selectively causes programmed cell death (apoptosis) in multiple myeloma cell lines without killing normal white blood cells;
GCS-100 blocks the growth of multiple myeloma cells from patients resistant to Velcade®, thalidomide, and dexamethasone;
GCS-100 inhibited the growth of multiple myeloma cells even when grown in the presence of bone marrow cells. The bone marrow environment protects multiple myeloma cells and provides a survival advantage for growing cells;
GCS-100 overcomes the protective effect of several proteins important for drug resistance and growth of multiple myeloma and other cancers, for example Bcl-2, Hsp-27, and NF-kB;
GCS-100 was shown to prevent the movement of multiple myeloma cells caused by VEGF, a protein important in angiogenesis and growth of multiple myeloma cells.
The paper concludes that "Collectively, these findings provide the frame work for clinical trials of GCS-100, either alone or in combination with dexamethasone, to enhance clinical efficacy, reduce toxicity, and overcome drug resistance to conventional and Velcade therapy in patients with relapsed/refractory multiple myeloma."
CEO's Comments
Bradley J. Carver GlycoGenesys' CEO and President and an author of the paper, stated, "Our ongoing myeloma trial is designed to get two looks at GCS-100, both alone and in combination with dexamethasone. This new preclinical data is quite relevant to our clinical trial strategy in multiple myeloma." He continued, "Thus, our top priority is to continue generating human clinical data."
GlycoGenesys has an ongoing Phase I/II dose escalation trial for treatment of multiple myeloma being conducted at Dana-Farber Cancer Institute and the Lucy Curci Cancer Center in Rancho Mirage, California. Additional sites are planned.
About The Trial
The Company is currently enrolling patients in it's Phase I/II dose escalation trial for treatment of multiple myeloma. The primary objective of the study is to evaluate the safety of GCS-100 when given to patients with relapsed or refractory multiple myeloma and to identify the recommended dose for future studies. Secondary objectives are to evaluate the response to GCS-100 as a monotherapy and in combination with dexamethasone and determine the pharmacokinetics of GCS-100 alone and with dexamethasone.
About Multiple Myeloma (MM)
Multiple myeloma is a bone marrow cancer in which white blood cells known as plasma cells, normally responsible for the production of infection-fighting antibodies, become abnormal and are overproduced. The proliferation of these abnormal plasma cells, called myeloma cells, results in decreased production of normal blood cells and disease-fighting antibodies. This proliferation causes growth of tumors that spread to multiple sites - hence the term multiple myeloma. The decreased white blood cell production weakens the immune system and decreased red blood cell production leads to fatigue and weakness, while the myeloma tumors cause bone destruction, pain and fractures.
MM is the second most common hematologic malignancy and although the disease is predominantly a cancer among older individuals (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and onset at a younger age. In the United States, more than 50,000 individuals have MM and over 14,600 new cases of the disease are diagnosed each year. Worldwide, there are approximately 74,000 new cases and over 45,000 deaths due to multiple myeloma each year. <<
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Stock is bouncing from negative territory on this news. The abstract:
>>Cancer Research 65, 8350-8358, September 15, 2005
Experimental Therapeutics, Molecular Targets, and Chemical Biology
A Novel Carbohydrate-Based Therapeutic GCS-100 Overcomes Bortezomib Resistance and Enhances Dexamethasone-Induced Apoptosis in Multiple Myeloma Cells
Dharminder Chauhan1, Guilan Li1, Klaus Podar1, Teru Hideshima1, Paola Neri1, Deli He1, Nicholas Mitsiades1, Paul Richardson1, Yan Chang2, Joanne Schindler2, Bradley Carver2 and Kenneth C. Anderson1
1 The Jerome Lipper Multiple Myeloma Center, Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School and 2 GlycoGenesys, Inc., Boston, Massachusetts
Requests for reprints: Kenneth C. Anderson, Dana-Farber Cancer Institute, Harvard Medical School, 44 Binney Street, Boston, MA 02115. Phone: 617-632-2144; Fax: 617-632-2140; E-mail: kenneth_anderson@dfci.harvard.edu.
Human multiple myeloma is a presently incurable hematologic malignancy, and novel biologically based therapies are urgently needed. GCS-100 is a polysaccharide derived from citrus pectin in clinical development for the treatment of cancer. Here we show that GCS-100 induces apoptosis in various multiple myeloma cell lines, including those resistant to dexamethasone, melphalan, or doxorubicin. Examination of purified patient multiple myeloma cells showed similar results. Specifically, GCS-100 decreases viability of bortezomib/PS-341–resistant multiple myeloma patient cells. Importantly, GCS-100 inhibits multiple myeloma cell growth induced by adhesion to bone marrow stromal cells; overcome the growth advantage conferred by antiapoptotic protein Bcl-2, heat shock protein-27, and nuclear factor-B; and blocks vascular endothelial growth factor–induced migration of multiple myeloma cells. GCS-100–induced apoptosis is associated with activation of caspase-8 and caspase-3 followed by proteolytic cleavage of poly(ADP-ribose) polymerase enzyme. Combined with dexamethasone, GCS-100 induces additive anti-multiple myeloma cytotoxicity associated with mitochondrial apoptotic signaling via release of cytochrome c and Smac followed by activation of caspase-3. Moreover, GCS-100 + dexamethasone–induced apoptosis in multiple myeloma cells is accompanied by a marked inhibition of an antiapoptotic protein Galectin-3, without significant alteration in Bcl-2 expression. Collectively, these findings provide the framework for clinical evaluation of GCS-100, either alone or in combination with dexamethasone, to inhibit tumor growth, overcome drug resistance, and improve outcome for patients with this universally fatal hematologic malignancy. <<
Cheers, Tuck |
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