<GLGS> Rick, is this company on anyone's screen? didn't know where to park this since I've never proposed a company look-see..wasn't sure if Peter minded these kinds of posts or not..edit: MCI definitely setting in..should know that answer by now..
I re-discovered this w/e..by accident..I wonder if it's worth putting in the portfolio? it's certainly not in marathon mode..but given its market cap?..
The science is intriguing to me..
GCS-100 is their only product..early studies in solid tumors show activity but most developed program is multiple myeloma and recently targeting CLL..
Rationale: GCS-100 inhibits the carbohydrate that feeds tumors(in its most simple terms!) apoptosis, angiogenesis main mechanisms(that they know of right now)This is where I need most help in judging whether this is a viable target..
Interesting approach, that they still have their doors open<g>, one year chart in addition to academic institution involvement are reasons for my wanting to explore
Below is latest synopsis of its current programs and plans..after this segment, I copied some links to recent events..big deal is they've been wrapped in litigation(still are) with their former CEO(Platt) who opened the doors of another carbohydrate company, thereby defaulting his termination agreement of no trade secrets/no competitive activities..GLGS is in Boston, and Platt's company is in Newton..oy vay..
Thinly traded, insiders own 30%, ELN a big chunk and NO institutional owners..
Whatta' you guys think?..they've had a stormy '04, much time/money in litigation, patent uncertainty(which apparently is a non-issue but would need to explore this further)..had a decent '04 ASH..and they seem to have better clinical focus with a plan by which to judge them??
Thanks!..A no rush homework project..congrats to Patriots fans!..I was rooting for the underdog:(
Zeta
GlycoGenesys, Inc. Announces Additional Cancer Indication for GCS-100LE Clinical Trial Program; Company Committed to Forming Strategic Alliance in 2005
BOSTON--(BUSINESS WIRE)--Jan. 25, 2005--GlycoGenesys, Inc., (NASDAQ: GLGS), a biotechnology company focused on carbohydrate-based drug development, announced a new indication, chronic lymphocytic leukemia (CLL), for its cancer clinical trial program for GCS-100LE. The addition of CLL to its clinical trial program positions GlycoGenesys to pursue approval in two indications for unmet medical needs in cancer and starts the international clinical and regulatory program for GCS-100LE. In recognition of the expanded clinical program, the Company announced its commitment to establishing a strategic alliance in 2005. It also provided a brief update on its ongoing Phase I dose escalation trial, while setting forth its 2005 goals including its multiple myeloma clinical trial program planned for early 2005.
SUMMARY
Today the Company announced that it:
* anticipates initiating a Phase I/II study in CLL in both the U.S. and England in the first half of 2005;
* seeks to establish a strategic alliance in 2005 to help fund the trials planned for the latter half of the year;
* is enrolling patients at the fifth out of six planned dose levels in its Phase I Dose Escalation trial for solid tumors, and has added two additional sites to assist enrolling up to 15 more patients once the maximum tolerated dose (MTD) for this dosing regimen is established;
* expects to begin the first of a two trial program in multiple myeloma at Dana Farber Cancer Institute in 1Q05;
* plans to initiate a second multiple myeloma trial in late 2005 anticipated to be designed as a pivotal trial. The Company's goal would be to file a New Drug Application (NDA) for multiple myeloma pending the quality of such trial results in 2007; and
* plans a Phase II solid tumor trial with GCS-100LE in late 2005;
2005 GOALS FOR GCS-100LE CANCER PROGRAM
Multiple Myeloma
Based on promising data recently presented in an abstract at the American Society of Hematology's 2004 Annual Meeting, the Company plans to initiate its first clinical trial for treatment of relapsed or refractory multiple myeloma patients in the first quarter under the direction of Drs. Kenneth Anderson and Paul Richardson of the Dana Farber Cancer Institute, Boston. Both were involved in studies leading to the regulatory approval of Velcade(R) for the treatment of multiple myeloma. The first trial of the Company's two trial program originally estimated to begin in the fourth quarter of 2004 is now expected to be initiated in the first quarter of 2005. In addition to the Dana Farber Cancer Institute, additional clinical sites are planned.
The second of the two multiple myeloma trials is targeted for initiation in late 2005. The Company will work with the FDA to design such trial as a pivotal study. The Company's goal would be to file an NDA in 2007 for treatment of multiple myeloma pending the quality of such trial results.
The primary objective of the first study is to evaluate the safety of GCS-100LE when given in subjects with relapsed or refractory multiple myeloma and to identify the recommended dose for further studies. Secondary objectives are to evaluate the response to GCS-100LE as a monotherapy and in combination with dexamethasone, a standard therapy, and determine the pharmacokinetics of GCS-100LE alone and with dexamethasone.
Chronic Lymphocytic Leukemia (CLL) - New Indication
The Company is expanding its clinical trial program to include CLL based on promising data recently presented in an abstract at the American Society of Hematology's 2004 Annual Meeting by Dr. Finbarr Cotter of Barts and the Royal London Medical School. The pre- clinical findings strongly support the scientific rationale for human clinical testing of GCS-100LE for treating CLL. As a result of Dr. Cotter's findings, he and a colleague, Dr. Archibald Prentice, President of the British Society for Haematology, are working closely with GlycoGenesys to design a clinical trial program. The first CLL clinical trial, a Phase I/II study, is planned to begin in the first half of 2005 with sites in both the U.S. and England.
This new clinical program positions GlycoGenesys to pursue approval in two indications for unmet medical needs in cancer (multiple myeloma and CLL) and starts the international regulatory process for GCS-100LE. 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 Tumor
Upon completion of its ongoing Phase I solid tumor dose ranging trial, the Company plans to initiate a Phase II clinical trial. The design of this Phase II trial will be based on clinical activity and continuing preclinical studies. The Company is employing the same scientific rigor as in the bloodborne indications while completing its current clinical trial prior to choosing specific solid tumor indications for Phase II. The Phase II solid tumor program is targeted to commence in late 2005.
STRATEGIC ALLIANCE - COMMITTED TO ESTABLISHING IN 2005
The Company recognizes the breadth of its clinical trial plans warrants consummating a strategic alliance during 2005. It further believes it has now achieved an appropriate level of development to recognize value from such a relationship. The Company believes a strategic alliance would likely benefit shareholder value, further validate its technology, and provide additional resources to conduct an expanded clinical trial program. The Company anticipates the clinical trials planned to begin later in 2005 will be undertaken in conjunction with a strategic alliance. The timing and/or success of these efforts can not be predicted or assured but the Company is committed to achieving this goal.
UPDATE
Phase I Dose Escalation Trial of GCS-100LE
GlycoGenesys' Phase I Dose Escalation trial for patients with advanced stage solid tumors is currently enrolling patients at the fifth out of a total of six dose levels currently planned under the protocol. Upon establishing the maximum tolerated dose (MTD), the trial protocol calls for enrolling approximately 15 additional patients at the MTD.
In addition to Sharp Memorial Hospital, Clinical Oncology Research, the Company recently initiated two new clinical sites and principal investigators:
* Daruka Mahadevan, M.D. Ph.D., Assistant Professor of Medicine, the Arizona Cancer Center, Tucson; and
* Michael Gordon, M.D., Associate Dean for Research, University of Arizona Programs, the Arizona Cancer Center - Greater Phoenix Area, Scottsdale, Arizona.
Dr. Gordon has acted as principal investigator on clinical trials for companies including Amgen, Eli Lilly, and Genentech. The Arizona Cancer Center is one of 21 comprehensive cancer centers in the United States, as designated by the National Cancer Institute. The addition of these sites should help expedite patient enrollment and adds two distinguished principal investigators to the study who are highly published in the field of oncology.
Elan owns roughly 10million shares but not sure how to calculate its holdings post stock split
ELN's 13-d
glycogenesys.com
1 year chart
finance.yahoo.com
Reverse split in December '04
glycogenesys.com
December ASH..2 posters delivered..
glycogenesys.com
glycogenesys.com
Update re: patent dispute and continuing litigation with former CEO
glycogenesys.com |
