| From: tuck | 11/11/2004 8:24:08 PM | | | | | | >>BOSTON--(BUSINESS WIRE)--Nov. 11, 2004---GlycoGenesys, Inc. (NASDAQ:GLGS - News), a biotechnology company focused on carbohydrate drug development, today announced that it has received a favorable decision in final and binding arbitration proceedings. The arbitration was brought by the Company against David Platt, its former CEO, who is now CEO of Pro-Pharmaceuticals, Inc. (AMEX:PRW - News).
Today's favorable ruling affirms the Company's exclusive rights to the disputed intellectual property. This intellectual property relates to GCS-100, the Company's lead drug candidate. The decision in favor of GlycoGenesys is final and binding and is only appealable based on strict and limited grounds. Under today's ruling Platt, as inventor, continues to prosecute patent applications covered by the license agreement for the benefit of the Company and the Company retains exclusive rights to the technology.
Bradley J Carver, CEO and President of GlycoGenesys, Inc. stated, "The 'cloud' that has overshadowed GlycoGenesys' accomplishments and intellectual property this year is now lifted. Our exclusive rights to GCS-100 have been undeniably determined. The value of past and future achievements relating to GCS-100 can now be properly recognized."
Mr. Carver continued, "We are sometimes required, as in this case, to take legal actions to defend and secure what is rightfully ours. This victory is an important milestone and good news for shareholders and employees who stayed the course with us. In accordance with today's ruling, Platt's prosecution of the patent applications in question will be solely for the benefit of the Company and this decision leaves no doubt to our rights under the license agreement to develop and commercialize GCS-100."
Legal synopsis of the decision
The arbitrator found that Platt had breached the license agreement by filing a patent application related to those already covered by the agreement without having informed the Company and affirmed the Company's position that Platt's subsequent patent application is also covered by the agreement. The arbitrator rejected Platt's contention that the Company had breached the license agreement and refused to terminate the agreement, as Platt had requested. Instead, the arbitrator found that the Company retained its exclusive rights to the technology in question. The arbitrator allowed Platt to continue prosecuting the patent applications in which he is listed as inventor, finding that Platt had not relinquished an inventor's right to control prosecution of his applications. Prosecution of the applications is for the benefit of the Company, which retains exclusive rights to develop and commercialize them. <<
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Cheers, Tuck |
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| From: tuck | 11/12/2004 1:12:06 AM | | | | | | And on the basis of the favorable arbitration outcome, they're going after Pro's product, and actually pretty much looking to litigate Pro out of business. Wowsers! Should be interesting day tomorrow.
>>BOSTON--(BUSINESS WIRE)--Nov. 11, 2004--GlycoGenesys, Inc., (Nasdaq: GLGS - News), a biotechnology company developing carbohydrate-based drugs, announced earlier today that it was awarded a favorable ruling in the arbitration proceedings brought by the Company against David Platt, its former CEO. With this favorable decision in hand, GlycoGenesys is taking the opportunity to describe the separate litigation with Platt and Pro-Pharmaceuticals, Inc. (AMEX:PRW - News), the company Platt now heads, and its business implications. This separate litigation, regardless of outcome, does not affect our rights to pursue commercialization of GCS-100.
Bradley J Carver, President and CEO of GlycoGenesys, Inc., said, "With the issuance of the favorable arbitration decision, the outstanding litigation risk and uncertainty relating to GlycoGenesys' intellectual property is clearly resolved. As we move forward, we believe the focus on litigation risks and uncertainties relating to intellectual property will shift to Platt and Pro- Pharmaceuticals, because we are seeking ownership of Davanat®."
Mr. Carver continued, "As previously disclosed, Platt initiated a separate litigation against GlycoGenesys largely in connection with his termination agreement. As part of this litigation, we have filed several counterclaims against Platt and Pro-Pharmaceuticals targeting their core intellectual property including Pro-Pharmaceuticals' lead product, Davanat. We are seeking the assignment of Davanat to GlycoGenesys and to prevent Platt and Pro- Pharmaceuticals from developing and selling polysaccharides to treat cancer. Much as GlycoGenesys has done through the arbitration process, we will pursue this legal action in a manner that minimizes management's time and is results driven."
"Platt's claims in the litigation, in which he seeks monetary damages, in our opinion are without merit. Moreover, we believe they represent limited financial exposure to us based on the amount of severance in dispute and the price and volume of our stock following the expiration of his lock-up and his realized proceeds," concluded Mr. Carver.
Litigation
Background:
In May 2000, David Platt signed a termination agreement and agreed not to compete with GlycoGenesys.
In July 2000, Platt incorporated Pro-Pharmaceuticals, Inc., a biotech company to develop carbohydrate-based drugs and drug-delivery products in the field of oncology.
In early 2001, the Company stopped severance payments under the termination agreement because of Platt's competitive activities with Pro-Pharmaceuticals, as well as other breaches of the termination agreement.
In the fall 2002 through summer 2003, Platt sold shares of GlycoGenesys subject to Rule 144 limitations.
In January 2004, the U.S. Patent and Trademark Office issued to GlycoGenesys U.S. Patent No. 6,680,306 "Method for Enhancing the Effectiveness of Cancer Therapies" covering the use of GCS-100® and other carbohydrates that bind to galectins prior to or in combination with chemotherapy or surgery for the treatment of cancer.
Pro-Pharmaceuticals' lead drug candidate, Davanat®, is a carbohydrate administered in combination with existing chemotherapies to potentially enhance their efficacy and reduce their toxicity. Pro-Pharmaceuticals publicly states that Davanat binds to galectins. Pro-Pharmaceuticals began developing Davanat shortly after David Platt signed a termination agreement with GlycoGenesys.
Lawsuit:
In late January 2004, Platt filed a lawsuit against the Company. In this suit, Platt seeks damages from the Company and certain of its directors for, among other claims:
alleged breach of the termination agreement between the Company and Platt for, among other things, failure to pay Platt severance (net payments of approximately $180,000);
alleged breach of fiduciary duty for failing to release transfer restrictions on his GlycoGenesys stock in an appropriate manner; and unfair trade practices.
In response to Platt's lawsuit, GlycoGenesys brought counterclaims against Platt and PRW asserting that:
Platt breached the non-competition provisions of his termination agreement within months of signing it by founding Pro-Pharmaceuticals and targeting carbohydrates to treat cancer;
Platt misappropriated GlycoGenesys' confidential information and used it to help develop Davanat and potentially other Pro-Pharmaceuticals technologies;
Platt and Pro-Pharmaceuticals engaged in business libel by making false statements in press releases and public statements about GlycoGenesys' intellectual property rights in GCS-100;
Platt breached the non-disparagement clause and other provisions set forth in the termination agreement;
and Platt and Pro-Pharmaceuticals both engaged in unfair trade practices.
The Company is seeking damages and permanent injunctive relief including:
an order to assign all rights in Davanat and other Pro-Pharmaceutical's inventions to GlycoGenesys;
a permanent injunction on Platt and Pro-Pharmaceuticals from developing, selling or using polysaccharide compounds to treat cancer;
a permanent injunction on Platt and Pro-Pharmaceuticals from using proprietary and confidential information of GlycoGenesys;
an injunction preventing Platt from participating in the business of Pro- Pharmaceuticals for 2 years;
and the recovery of all payments made to Platt under the termination agreement as well as associated costs and attorneys fees. <<
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Cheers, Tuck |
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| From: tuck | 11/12/2004 10:00:45 AM | | | | | | Of course, PRW counters:
>>NEWTON, Mass.--(BUSINESS WIRE)--Nov. 12, 2004--Pro-Pharmaceuticals, Inc. (Amex: PRW - News)
Patent Applications Relate to GCS-100, GlycoGenesys' Core Technology
Decision Has No Bearing on Dr. Platt's Lawsuit Against GlycoGenesys or Their Counterclaims Against Dr. Platt & Pro-Pharmaceuticals
David Platt, Ph.D., CEO & President of Pro-Pharmaceuticals, Inc. (Amex: PRW - News), today said he was gratified by the Arbitrator's decision to allow him to continue to control the prosecution of his patent applications that relate to the modified pectin technology that he developed and licensed to GlycoGenesys, Inc. (Nasdaq: GLGS - News) in 1994.
The Arbitrator ruled that Dr. Platt will continue to retain the power of attorney to control prosecution of his U.S. Patent Application Number 08/024,487 ("487"), as well as his related U.S. Patent Application Number 08/819,356 ("356") and that both parties, Dr. Platt & GlycoGenesys, continue to be bound by the terms of their 1994 License Agreement. The Arbitrator suggested, but not ordered, that so long as the License Agreement is in effect, Dr. Platt's counsel keep GlycoGenesys' counsel informed of any significant development or occurrence in the prosecution of those Patent Applications.
In 1994, Dr. Platt exclusively licensed certain inventions, and granted the licensee, GlycoGenesys, power of attorney to prosecute patent applications covered by the license, including Dr. Platt's '487 Patent Application. The License Agreement relates to GlycoGenesys' GCS-100, a modified pectin material-based drug previously known as GBC-590. Dr. Platt developed this modified pectin-based technology prior to founding GlycoGenesys in 1993.
In December 2003, Dr. Platt revoked GlycoGenesys' power of attorney to prosecute the licensed patent applications because, among other things, he believed GlycoGenesys had a conflict of interest insofar as GlycoGenesys had in 2001, after Dr. Platt left GlycoGenesys, "licensed in" from Wayne State University a patent issued to Dr. Avraham Raz.
GlycoGenesys formally initiated an arbitration proceeding in early 2004, pursuant to provisions in the License Agreement, and sought preliminary injunctive relief in Massachusetts Superior Court (twice) and before an Arbitrator (once) in order to require Dr. Platt to restore the patent prosecution power to GlycoGenesys. GlycoGenesys has not succeeded in its three attempts and the power of attorney to prosecute his '487 & '356 Patent Applications remain with Dr. Platt.
In February 2004, Dr. Platt notified GlycoGenesys of his intention to terminate their License Agreement. Specifically, Dr. Platt asserted as grounds for his intention to terminate the License Agreement by its: (1) failure to recuse itself from representation of the '487 Patent Application in the potential interference proceeding with the U.S. Patent Number 5,834,442 ("442") Patent from Wayne State University despite GlycoGenesys' obvious conflict of interest; (2) GlycoGenesys' failure to prosecute diligently the '487 Patent Application by failing to take steps to provoke an interference proceeding to establish the priority of the '487 Patent Application over the '442 Patent; and (3) GlycoGenesys' licensing of the '442 Patent from Wayne State University with knowledge of the Patent's questionable validity, fully acknowledged by GlycoGenesys in the Wayne State License Agreement itself. In response, GlycoGenesys denied that it had breached the License Agreement and continued to refuse to recuse itself from prosecution of the '487 Patent Application.
During the period from late 2003 to 2004, Dr. Platt was notified that patents for his modified pectin material have been granted in the European Union, Canada, Australia and New Zealand. Dr. Platt also received notice during the same timeframe that GlycoGenesys had abandoned foreign counterparts to his U.S. Patent Application '356 in Europe, Canada, Brazil, Israel, Japan and China. Dr. Platt stepped in to continue the prosecution of the foreign counterpart patent applications that GlycoGenesys abandoned. Dr. Platt's '356 Patent Applications in the U.S. and other international countries are currently pending.
Dr. Platt was Chairman and CEO of GlycoGenesys until May 2000. He founded Pro-Pharmaceuticals in July 2000. Pro-Pharmaceuticals has developed patented technology involving carbohydrate compounds as a targeting mechanism intended to upgrade the safety and efficacy of FDA-approved anti-cancer agents.
Lawsuit Status
In a lawsuit filed in January 2004, Dr. Platt seeks damages from GlycoGenesys for breach of his June 2000 Separation Agreement for, among other things, failure to pay him his two-year severance (payments stopped in January 2001), breach of fiduciary duty for failing to release the transfer restriction on his GlycoGenesys stock and unfair trade practices. In his lawsuit, Dr. Platt alleges that GlycoGenesys, among other things, breached his separation agreement, which terminated in June 2002. Dr. Platt seeks monetary damages and other relief.
GlycoGenesys' counterclaims against Dr. Platt and Pro-Pharmaceuticals include among other things, breach of contract, tortious interference with the separation agreement, misappropriation of proprietary rights, unfair trade practices, and false statements for which GlycoGenesys seeks damages and injunctive relief.
Dr. Platt and Pro-Pharmaceuticals believe these counterclaims are without merit and will contest them vigorously. This litigation is in early stages of discovery.
What is the difference between Pro-Pharmaceuticals' DAVANAT® technology and GlycoGenesys' modified pectin-based drug GCS-100?
Pro-Pharmaceuticals' lead compound, DAVANAT®, is a target delivery system that enables the delivery of chemotherapy drugs to cancer cells and is not an Active Pharmaceutical Ingredient (API). GlycoGenesys' lead drug GCS-100 is an API. Consequently, DAVANAT® and GCS-100 are two distinctly different therapeutical entities. They differ in chemistry and biological activity, as well as therapeutical classes.
The inventions developed by Dr. Platt, the modified pectin material described in the '487 Patent Application and licensed to GlycoGenesys, and the galactomannan described in U.S. Patent Number 6,645,946 ("946"), the DAVANAT® compound assigned to Pro-Pharmaceuticals, are substantially different, particularly in light of Dr. Anatole Klyosov's substantial contribution to the invention embodied in the '946 Patent. Dr. Klyosov is a co-founder and Consulting Chief Scientist of Pro-Pharmaceuticals as well as an inventor of DAVANAT®, the subject of the '946 Patent.
DAVANAT® is one of the galactomannans studied by Dr. Klyosov and his colleagues since 1982 at the Russian Academy of Sciences and developed by Drs. Klyosov & Platt in 2001 as a pharmaceutical vehicle to reduce chemotherapeutic side effects. These innovations in drug targeting were disclosed in the '946 Patent, filed in March 2001, and assigned by the U.S. Patent & Trademark Office to Pro-Pharmaceuticals in November 2003.
Of note, GlycoGenesys' Chief Financial Officer and Vice President of Business Development presented a corporate update at the Rodman & Renshaw Global Healthcare Conference "Techvest" held in London in May 2004. In their presentation, the "Competitive Landscape" slide listed seven companies that GlycoGenesys believes have competitive products. That list of competitors did not include Pro-Pharmaceuticals or its DAVANAT® technology. <<
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But GLGS is up 30% right now, and PRW is down 7%.
Cheers, Tuck |
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| To: gravis909 who wrote (26) | 11/17/2004 5:17:28 PM | | From: tuck | | | | Boy, I don't know. We need an actual clinical update, not legal gyrations, to move the stock. If that's not forthcoming, delisting will happen. If I can divine anything from a recent presentation, I'll post about it. Right now, I'd be cautious in front of the delisting issue:
>>BOSTON--(BUSINESS WIRE)--Nov. 17, 2004-- GlycoGenesys, Inc. (NASDAQ:GLGS - News), a biotechnology company focused on carbohydrate drug development, today announced results from its Form 10-Q for the quarter ended September 30, 2004.
Select Financial Highlights:
The net loss applicable to common stock for the three months ended September 30, 2004 and 2003 was $(2,799,576), or $(0.05) per share, and $(1,934,519), or $(0.05) per share, respectively. For the nine months ended September 30, 2004 and 2003 the net loss applicable to common stock was $(8,288,125), or $(0.15) per share, and $(5,499,521), or $(0.14) per share, respectively. The net loss applicable to common stock for the three months ended September 30, 2004 and 2003 included a $115,021 and $104,562 charge for the accretion of dividends on the Company's Series B preferred stock, respectively. The net loss applicable to common stock for the nine months ended September 30, 2004 and 2003 included a $342,564 and $310,277 charge for the accretion of dividends on the Company's Series B preferred stock, respectively.
John W. Burns, SVP and CFO of GlycoGenesys, Inc. stated, "Higher clinical trial costs this quarter were the largest single component to the approximately $865,000 increase in the Company's net loss applicable to common stock over the same period last year. Other expense categories contributing to the increase were legal, consulting, laboratory and payroll-related costs, all partially offset by decreases in drug production costs and rent."
"Moreover, the $2.8 million increase in net loss applicable to common stock experienced for the first three quarters of 2004 over 2003 was primarily due to increases in expenses for legal, drug development and production for clinical trials, consulting, clinical trials, payroll, laboratory and investor relations," added Mr. Burns.
"We recently achieved major milestones through the favorable arbitration decision and poster presentations to be given at the American Society of Hematology annual meeting in early December," stated Mr. Burns. "We received a delisting notice from the Nasdaq Stock Market for failure to meet its $1 bid price listing requirement by November 15th. We will take advantage of the hearing process afforded to listed companies. Our stock will remain listed pending Nasdaq's hearing which we expect to take place within 45 days of our request. We are evaluating the alternatives available to us and will work on a solution in the best interest of current shareholders," he added. <<
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Cheers, Tuck |
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| To: tuck who wrote (27) | 12/6/2004 11:44:50 AM | | From: tuck | | | | >>BOSTON & SAN DIEGO--(BUSINESS WIRE)--Dec. 6, 2004-- GlycoGenesys, Inc., (NASDAQ: GLGS - News), a biotechnology company focused on carbohydrate drug development, announced today its lead drug candidate, GCS-100LE, was shown in vitro to trigger cell death in multiple myeloma, including cell lines resistant to standard treatments. The data was presented at The American Society of Hematology 46th Annual Meeting and Exposition in a poster session called New Targets and Immune Based Therapy in a presentation entitled "Mitochondria and Caspase-Independent Cell-Death Triggered By GCS-100, a Novel Carbohydrate-Based Therapeutic in Multiple Myeloma (MM) Cells." The poster was presented by Company collaborator, Dr. Dharminder Chauhan, of Dr. Kenneth Anderson's laboratory at the Medical Oncology Department, Dana Farber Cancer Institute, Boston, Massachusetts.
Highlights of Poster Presentation
GCS-100LE was found to:
Directly target multiple myeloma cells including in their bone marrow microenvironment.
Trigger cell death in multiple myeloma cells resistant to traditional anti-cancer agents including dexamethasone, melphalan, doxorubicin, and Velcade®, which are commonly used in treatment of multiple myeloma.
Decrease the viability of Velcade-resistant multiple myeloma patient cells.
Inhibit growth and survival of multiple myeloma cells conferred by the bone marrow microenvironment.
Overcome drug-resistance conferred by anti-apoptotic protein Bcl-2 and heat shock protein- 27.
Induces cell death in multiple myeloma without activating known cell death activating pathways, caspases 8, 9,and 3, without significant toxicity against normal peripheral mononuclear cells, suggesting a potentially novel mechanism of action and providing strong rational for combining GCS-100LE with approved agents that activate caspase-dependent cell death.
To have additive and synergistic effects when combined with caspase-activating agents dexamthasone and PK1195, respectively.
These findings lay the framework for clinical evaluation of GCS-100LE either alone or in combination with other therapies to overcome drug resistance and improve patient outcome in multiple myeloma.
Bradley J Carver, President and CEO of GlycoGenesys, noted that "We are very pleased to have this promising data presented at the ASH Annual Meeting by such distinguished clinicians and researchers. As a co-author with my colleagues on this abstract and working closely with Dr.'s Anderson and Chauhan over the last year, we are excited about our plans to enter the clinic in multiple myeloma with GCS-100LE in early 2005 at the Dana Farber Cancer Institute."
The Study
Multiple myeloma cancer cells use normal bone marrow stromal cells and the bone marrow microenvironment to prevent apoptosis (programmed cell death), which allows them to divide and grow abnormally. GCS-100LE works by directly targeting multiple myeloma cells in their bone marrow microenvironment, interfering with their ability to adhere to the bone marrow stromal cells and inhibiting their growth and proliferation, eventually leading to cell-death. GCS-100LE was shown to trigger growth arrest and apoptosis in a number of multiple myeloma cell lines including cell lines resistant to standard treatments such as dexamethasone, melphalan and doxorubicin. In tests with multiple myeloma cells from patients who have had unsuccessful treatment due to drug resistance, GCS-100LE demonstrated similar results, including in cells from patients resistant to bortezomib (Velcade®). GCS-100LE was effective against these patient's cells without significant toxicity to normal peripheral mononuclear cells, which naturally help defend against infections and disease.
In this study, it was shown that GCS-100LE induced apoptosis in multiple myeloma cells through a mitochondria and caspase-independent apoptotic pathway. This provides a rationale for combining it with treatments that work through potentially complimentary apoptotic pathways, including caspase-dependent pathways. For example, in combinatonGCS-100LE, acts synergistically with PK-11195 and additively with dexamethasone.
About Multiple Myeloma
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a progressive hematologic (blood) disease. It is a cancer of the plasma cell, an important part of the immune system that produces immunoglobulins (antibodies) to help fight infection and disease. Hypercalcemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin are common clinical manifestations of multiple myeloma. It is often also characterized by diffuse osteoporosis, usually in the pelvis, spine, ribs, and skull.
The estimated frequency of multiple myeloma is 4-5 new cases per 100,000 persons per year. Accordingly, in the United States 15,270 new cases are expected to be diagnosed in 2004. At present there are approximately 50,000 people in the United States living with multiple myeloma.
About GCS-100LE
GCS-100LE is a novel carbohydrate compound with potential application in solid tumors and bloodborne cancers. Independent research has shown that Galectin-3, a key target of GCS-100, is implicated in several cellular activities. GCS-100 has at least three mechanisms of action: it may induce apoptosis, or programmed cell death; appears to interfere with angiogenesis, the process by which cancer cells recruit a blood supply from the body in order to proliferate; and appears to interfere with a process called cellular adhesion, which plays a key role in metastasis, or the spread of cancer beyond the primary tumor. Galectin-3 has high expression in many cancers, but not in normal cells, conferring broad potential applications for GCS-100 in solid and blood-borne cancers. GCS-100 has been evaluated at lower dose levels in Phase II(a) clinical trials for colorectal and pancreatic cancer. GCS-100LE, a low ethanol formulation, is currently in a dose escalation Phase I trial for solid tumors with Phase I and II clinical trials for multiple myeloma planned to begin in 2005. <<
GLGS needs decent results, interim, whatever, from one the clinical studies very soon to avoid delisting.
Cheers, Tuck |
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| From: tuck | 12/7/2004 2:30:25 PM | | | | | | >>BOSTON & SAN DIEGO--(BUSINESS WIRE)--Dec. 7, 2004-- GlycoGenesys, Inc., (Nasdaq: GLGS - News), a biotechnology company focused on carbohydrate-based drug development, announced today that an in vitro study showed for the first time that its lead drug candidate, GCS-100LE, triggered cell death in both B-cell malignant cell lines and primary cancer cells taken from patients with chronic lymphocytic leukemia (CLL). GCS-100LE, currently in a Phase I dose escalation trial for solid tumors, is a novel carbohydrate-based compound being developed for the treatment of solid tumors and multiple myeloma. Data from the new study was presented last evening by world-renowned cancer researcher and GlycoGenesys collaborator, Dr. Finbarr E. Cotter of Barts School of Medicine, London, at the American Society of Hematology (ASH) 46th Annual Meeting and Exposition in a poster session on Lymphoma Therapy - New Biologic Agents. The poster was titled "GCS-100, a Galectin 3 Antagonist, Is a Novel Caspase-9 Apoptosis Activating Agent for the Treatment of Indolent B-Cell Malignancies."
Dr. Cotter's Poster Presentation Highlights
GCS-100LE was found to:
Induce significant apoptosis (cell death) in both malignant B-cell lines and in primary patient chronic lymphocytic leukemia cells in vitro with minimal effect against normal B-cells and stem cell cultures.
Greatly enhance the apoptotic effect of chemotherapy at low doses, even in the presence of high levels of anti-apoptotic proteins such as Bcl-2.
Induce cell death in B-cell malignancies including chronic lymphocytic leukemia via caspase-9, a known apoptotic pathway utilized by approved chemotherapy agents. Activation of caspase-9 has been shown to predict a good anti-cancer response in B-cell malignancies.
These findings lay the framework for clinical evaluation of GCS-100LE in B-cell malignancies, especially for potential treatment of chronic lymphocytic leukemia.
The Study
The study investigated the mechanism by which GCS-100LE induces apoptosis (programmed cell death) in indolent B-cell lymphomas. It found that GCS-100LE induced apoptosis in malignant cell lines as well as in primary cells from patients with chronic lymphocytic leukemia with minimal effect on normal B cells. Notably, low doses of GCS-100LE significantly enhanced the effect of chemotherapy in these cancer cells. GCS-100LE was found to induce a specific apoptotic pathway, the mitochondrial caspase-9 pathway. The apoptotic effect of GCS-100LE occurred even in the presence of the protein Bcl-2, a natural inhibitor of cell death, which confers resistance to widely used chemotherapy drugs in several cancers. GCS-100LE has been previously shown to bind to Galectin-3, a protein that generally has a higher expression in B-cell cancers. This may be the cause of GCS-100LE's targeting of malignant B-cells.
Dr. Finbarr Cotter, GlycoGenesys' collaborator and primary author of the study abstract said, "Our recent study shows for the first time that GCS-100LE has strong activity against primary cancer cells taken from patients with chronic lymphocytic leukemia. In these primary cells and in other B-cell cancer cell lines, GCS-100LE works through a specific caspase-dependent apoptotic pathway. Moreover, other studies have shown that GCS-100LE can activate additional beneficial anti-cancer mechanisms. These attributes of GCS-100LE suggest its application in several different types of cancer and its combination with chemotherapeutic agents that work through complementary pathways for a potential synergistic or additive therapeutic effect. I am keen to commence clinical studies based on this preclinical work."
Bradley J Carver, President and CEO of GlycoGenesys, a secondary author of the study abstract, further commented, "Our poster presentations at this year's annual meeting of the American Society of Hematology underscore the clinical rationale and versatility of GCS-100LE to be developed for potential treatment of several bloodborne cancers. We are encouraged by Dr. Cotter's recent findings. They provide solid scientific rationale for expanding the clinical development of GCS-100LE beyond our current programs in solid tumor and multiple myeloma.
About Indolent B-cell Malignancies
In the U.S., over 320,000 people are estimated to have some form of B-cell malignancy and each year approximately 55,000 new cases and 20,000 deaths occur from these cancers. Between 80% and 85% of non-Hodgkin's lymphomas are of B-cell origin. Indolent B-cell malignancies include chronic lymphocytic leukemia, follicular lymphoma and B-cell non-Hodgkin's lymphoma as well as other lymphomas. They are low-grade or slow-growing lymphomas that permit long survival periods but are continuously recurring and virtually incurable in advanced stages. Current treatment options are characterized by low-cure rates due to the slow-growing nature of these lymphomas. Patients without symptoms are monitored closely for development of symptoms including tumor masses and major organ involvement. At such times, treatment is started.
About GCS-100LE
GCS-100LE is a novel carbohydrate compound with potential application in solid tumors and bloodborne cancers. Independent research has shown that Galectin-3, a key target of GCS-100LE is implicated in several cellular activities. GCS-100LE has at least three mechanisms of action: it may induce apoptosis, or programmed cell death; appears to interfere with angiogenesis, the process by which cancer cells recruit a blood supply from the body in order to proliferate; and appears to interfere with a process called cellular adhesion, which plays a key role in metastasis, or the spread of cancer beyond the primary tumor. Galectin-3 has high expression in many cancers, but not in normal cells, conferring broad potential applications for GCS-100LE in solid and bloodborne cancers. GCS-100 has been evaluated at low dose levels in previous clinical trials for patients with colorectal, pancreatic and other types of solid tumors. GCS-100LE, a low ethanol formulation, is currently in a dose escalation Phase I trial for solid tumors with Phase I and II clinical trials for multiple myeloma planned in 2005. <<
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Cheers, Tuck |
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| To: tuck who wrote (29) | 12/13/2004 4:12:48 PM | | From: tuck | | | | Reverse split to help avoid delisting, among other supposed benefits:
>>BOSTON--(BUSINESS WIRE)--Dec. 13, 2004--GlycoGenesys, Inc., (Nasdaq: GLGS - News), a biotechnology company focused on carbohydrate-based drug development, announced today that the Company's Board of Directors had approved a 1-for-6 reverse stock split of the Company's common stock. The split affects all stockholders uniformly and will not affect any stockholder's percentage ownership in the Company. To the extent that the split results in a holder becoming entitled to a fractional share, the fractional share will be rounded up to a whole share for the benefit of the shareholder. As a Nevada corporation, a shareholder vote is not required to effect the split of its shares. Shares held as of the close of business on December 20, 2004 will be split and the shares will begin trading on a post-split basis the following day, December 21, 2004. For a period of 20 trading days following the split the Company's common stock will trade under the temporary symbol "GLGS.D" to reflect the occurrence of the split. In addition to reducing the number of shares outstanding, the number of authorized shares available for future issuance will also be reduced by a 1-for-6 ratio. All warrants, options and preferred stock outstanding at the time of the split are also subject to the reverse split formula including customary upward repricing.
Comments From Management
John W. Burns, the Company's Senior Vice President and CFO, stated, "Today's announcement is more than about simply taking steps to retain our Nasdaq listing. This year we have made significant progress operationally, scientifically, and clinically. We believe these achievements have been under recognized by the capital markets due to, among other things, our capital structure, which is uncharacteristic of many biotech companies at our stage of development. As evidenced by the results in our recently announced American Society of Hematology abstracts, GlycoGenesys has the potential for a bright future and it became necessary to change our capital structure to provide the best opportunity, in our opinion, for long-term shareholder value."
Bradley J Carver, the Company's President and CEO, stated, "Along with our shareholders senior management and the Board of Directors together are significant stake-holders in GlycoGenesys and carefully weighed the interest of our shareholders in arriving at this decision to reduce our share count. By reducing the share count, we are taking a step we believe is necessary to improve the potential for our shareholders to benefit from our milestones going forward. 2005 looks to be a milestone intensive year including human clinical data from our solid tumor dose escalation trial, initiating our multiple myeloma study at Dana Farber, expanding our clinical trial program for GCS-100LE and entering into a potential strategic partnership. In addition to clinical milestones, we expect additional research publications on GCS-100LE and plan to keep a high profile at industry and investor conferences."
Potential Benefits of The Reverse Stock Split
The reverse stock split reduces the number of GlycoGenesys' shares outstanding to a level more comparable with those of similar biotechnology companies and more appropriate to the current size, stage and scope of the Company's business. Fewer shares outstanding and a higher stock price may help to generate more interest from fundamental institutional investors among funds that are either precluded by their bylaws from investing in lower-priced stocks or are simply reluctant to do so. In addition, many analyst and brokerage firms are reluctant to recommend lower-priced stocks to either their clients or monitor performance of lower-priced stocks. Moreover, the stock split provides an opportunity to satisfy Nasdaq's $1.00 bid price requirement.
Today's announcement is part of a multi-step process by the Company's management and Board of Directors to increase long-term shareholder value by taking the necessary actions to maintain its Nasdaq listing, attracting new long-term institutional investment through both open market and private transactions, and solidifying its current shareholder base by taking these steps toward creating lasting value.
Example For Shareholders of How the 1-for-6 Split Works
A shareholder having 9,000 shares before the split would have 1,500 shares after the split; similarly, a shareholder with 10,000 shares before, would have 1,667 after (taking into effect rounding up).
The Company's capital structure pre- & post-split is as follows:
Pre-Split Post-Split
(approximate)
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Shares Outstanding 60,504,577 10,084,096
Common
Shares Underlying
Convertible Preferred 10,189,763 1,698,294
Warrants-Shares Issuable 21,571,326 3,595,221
Options-Shares Issuable 1,849,500 308,250
Authorized Shares 200,000,000 33,333,333
Options Available for Issuance
under the Company's Incentive
Plans 2,552,070 425,345<<
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Cheers, Tuck |
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