Navigation Links
Clinical study shows biological and clinical activity in relapsed leukemia patients
Date:6/4/2008

LUGANO, SWITZERLAND, June 4, 2008 Finbarr Cotter, M.D., Ph.D., Professor of the Institute of Cell and Molecular Science at Barts and The London School of Medicine, today presented in an oral session "Clinical Caspase Activation in CLL by GCS-100: a Phase 2 Study" at the 10th International Conference on Malignant Lymphoma (10-ICML). The promising interim results from this ongoing clinical trial indicate that single-agent GCS-100 induces apoptosis (programmed cell death) in patients' CLL cells, reduces leukocyte count in some patients and is generally well tolerated. GCS-100 targets galectin-3, a protein over-expressed in cancer cells that promotes their survival, proliferation and metastasis.

The ongoing Phase 2 single-arm study of GCS-100 given intravenously as a single agent to relapsed CLL patients is designed to evaluate the effects of GCS-100 on various markers of apoptosis and to assess clinical activity and safety. Patients enrolled have had between one and two prior therapy regimens, which included chlorambucil, fludarabine, cyclophosphamide, and rituximab in combination or as a single agent. Of the nine patients enrolled to-date, six are evaluable for biological marker activity and five are evaluable for clinical activity.

The primary objective of the study is to evaluate the effect of GCS-100 on biomarkers of apoptosis in patients' CLL cells. Caspases -8 and -9 were activated in the CLL cells from all six evaluable patients, as measured by western blot analysis. DNA fragmentation in patients' CLL cells also was observed, strengthening the evidence that GCS-100 induces apoptosis.

The secondary objective of the study is to evaluate the effect of GCS-100 on peripheral blood leukocyte counts, which are aberrantly elevated in CLL patients. Of the five evaluable patients, two had significant reductions in leukocyte counts compared with baseline levels, including one with a 76% reduction and another with a 42% reduction and a reduction in lymph node size.

GCS-100 was generally well tolerated in the nine patients treated to-date. None of the patients had myelotoxicities, such as neutropenia, lymphopenia or thrombocytopenia, associated with GCS-100. The most common adverse event was rash, which was generally self-limiting and mild-to-moderate in severity. One patient experienced a grade 3 adverse event (indigestion and epigastric pain) and ended treatment. One patient died of pneumonia unrelated to GCS-100.

"These signals of biologic and clinical activity were without signs of overlapping toxicities, such as myelotoxicity, found in current therapies for CLL," said Dr. Cotter. "These early data are particularly encouraging given that relapsed patients, especially those previously treated with standard agents such as fludarabine and rituximab, are difficult to treat."

Based on these results and encouraging preclinical evidence of synergy of GCS-100 with cytotoxic agents, Prospect Therapeutics is planning to initiate a clinical trial of GCS-100 combined with chemotherapy in CLL patients following the completion of this single-agent trial.

GCS-100 Overview

GCS-100 is a proprietary polysaccharide that targets galectin-3. Galectin-3 is a protein over-expressed in cancer cells that promotes their survival, proliferation and metastasis. Galectin-3 is part of a family of proteins that bind to carbohydrates and is found in high concentrations in many human cancerous tumors, including chronic lymphocytic leukemia, multiple myeloma and lymphoma.

CLL Overview

CLL, a blood-borne cancer, is the most common form of adult leukemia worldwide. CLL is characterized by proliferation of malignant white blood cells, referred to as lymphocytes, in the bone marrow, lymph nodes and spleen, which leads to an increase in white blood cell counts as well as enlarged lymph nodes and spleens in most patients. The disease is progressive and often fatal with a five year survival rate of 75%. According to The Leukemia & Lymphoma Society, approximately 95,000 patients have CLL in the United States, and there were approximately 15,300 new cases of CLL diagnosed in the United States in 2007.


'/>"/>

Contact: Michelle Linn
linnmich@comcast.net
508-362-3087
Linnden Communications
Source:Eurekalert

Related medicine news :

1. Radiologists encouraged to look beyond cancer for clinically unseen diseases
2. Clinical depression linked to abnormal emotional brain circuits
3. Preclinical study suggests organ-transplant drug may aid in lupus fight
4. Provectus Pharmaceuticals, Inc. Begins Phase 2 Clinical Trial for Metastatic Melanoma
5. Good Clinical Practice Journal Awards: Winners Announced
6. Microsoft Helps Developers of Clinical User Interfaces Improve Efficiency, Patient Safety With Free Toolkit
7. Study Questions Dead-End Cancer Clinical Trials
8. Genomic Health Announces Multiple Studies on Oncotype DX(TM) Presented at 2007 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium
9. Clinical trials present better alternatives for dialysis patients
10. Mirixa Debuts New Clinical Technology Solutions for Enhancing Patient Care
11. IMPACT initiative looks to improve patient participation in clinical trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... ... First Choice Emergency Room , the largest network of independent freestanding emergency ... its new Mesquite-Samuell Farm facility. , “We are pleased to announce Dr. Ogunleye ... M. Muzzarelli, Executive Medical Director of First Choice Emergency Room. , Dr. Ogunleye ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced ... feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as a ... has released tools for healthy coping following a traumatic event. , Trauma sufferers tend ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension ... that it will receive two significant new grants to support its work to ... its 25th anniversary by recognizing patients, medical professionals and scientists for their work ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... 2016  Guerbet announced today that it has been ... Award . One of 12 suppliers to ... its support of Premier members through exceptional local customer ... commitment to lower costs. ... our outstanding customer service from Premier," says Massimo ...
(Date:6/23/2016)... YORK , June 23, 2016 ... waters, but it continues to present great opportunities to ... companies for today: Intrexon Corp. (NYSE: XON ... Arena Pharmaceuticals Inc. (NASDAQ: ARNA ), and ... more about these stocks and receive your complimentary trade ...
Breaking Medicine Technology: