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:10/13/2017)... ... ... Lori R. Somekh, founder of the Law Office of Somekh & ... and special needs planning attorneys. “Membership in ElderCounsel helps our office remain up to ... with elder law attorneys nationwide,” said Somekh. , ElderCounsel was founded ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) ... a collection of specialty vendors and unique items from across the nation, this holiday-themed ... and wellness services offered by the VNA. The boutique will be open Saturday, ...
(Date:10/13/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... and least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints ... for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says ...
(Date:10/13/2017)... ... , ... “The Journey: From the Mountains to the Mission Field”: the story ... the Philippines. “The Journey: From the Mountains to the Mission Field” is the creation ... has taught all ages and currently teaches a class of ladies at her church, ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent ... sleep apnea using cutting-edge Oventus O2Vent technology. As many as 18 million ... by frequent cessation in breathing. Oral appliances can offer significant relief to about ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... 2017  In response to the nationwide opioid ... Surgeons (AAOMS) released prescribing recommendations that urge ibuprofen ... as a first-line therapy to manage a patient,s ... Recognizing the value and importance of ... Prescribing: Acute and Postoperative Pain Management" stresses that ...
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, the ... by Walgreens and pharmacy benefit manager Prime Therapeutics LLC ... brand, which included the unveiling of new signage at ... as well as at a few other company-owned facilities ... brand to patients, some of whom will begin to ...
Breaking Medicine Technology: