Proof-of-Concept Study to Determine Safety and Efficacy in 10 Patients With Moderate-to-Severe Plaque Psoriasis
NORCROSS, GA, USA I September 24, 2015 I Galectin Therapeutics Inc. (GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces the start of a 10-patient pilot study with GR-MD-02 in patients with moderate-to-severe plaque psoriasis.
The genesis of this study is the apparent remission of a patient with severe psoriasis who participated in the Company’s Phase 1 study cohort of 4 mg/kg of GR-MD-02 for the treatment of non-alcoholic steatohepatitis (NASH). That patient received her fourth infusion of GR-MD-02 in May 2014, and her psoriasis remained in complete remission for 17 months, with slight scaling becoming evident on her elbows just this month.
“We are excited to begin this study at the Brooke Army Medical Center in San Antonio, Texas,” said Peter G. Traber, M.D., Galectin’s president, chief executive officer and chief medical officer. “We know from the scientific literature that galectin-3 is at higher levels in the skin of psoriasis patients, and that GR-MD-02 inhibits galectin-3. It would follow that GR-MD-02 could affect this disease. We are hopeful that patients with moderate-to-severe plaque psoriasis will show a clearing of their disease without the negative side effects associated with many of the currently available therapies. In addition, a successful pilot study would add to our robust therapeutic pipeline for this compound.”
Psoriasis, which manifests most often as plaque psoriasis, is a chronic, relapsing, inflammatory skin disorder. Although plaque psoriasis is rarely life threatening, it often is intractable to treatment. According to the International Federation of Psoriasis Associations, about 3% of the world’s population has some form of psoriasis. In the U.S. there are about 150,000 new cases every year, and psoriasis affects about 2% of the population, according to the Cleveland Clinic.
About the Psoriasis Study
This study is a Phase 2a open-label trial in patients with moderate-to-severe plaque psoriasis in which 10 psoriasis patients with >= 10% of their skin affected and a PASI (psoriasis activity and severity index) of >= 12 points will be treated with 8 mg/kg of GR-MD-02 every other week for a total of seven infusions. The primary endpoint will be the PASI-75, or a 75% improvement in the severity of the disease 30 days following the final infusion. More information on the trial can be found in a CEO Perspective published today, which can be found here.
About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scaring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
SOURCE: Galectin Therapeutics
Post Views: 57
Proof-of-Concept Study to Determine Safety and Efficacy in 10 Patients With Moderate-to-Severe Plaque Psoriasis
NORCROSS, GA, USA I September 24, 2015 I Galectin Therapeutics Inc. (GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces the start of a 10-patient pilot study with GR-MD-02 in patients with moderate-to-severe plaque psoriasis.
The genesis of this study is the apparent remission of a patient with severe psoriasis who participated in the Company’s Phase 1 study cohort of 4 mg/kg of GR-MD-02 for the treatment of non-alcoholic steatohepatitis (NASH). That patient received her fourth infusion of GR-MD-02 in May 2014, and her psoriasis remained in complete remission for 17 months, with slight scaling becoming evident on her elbows just this month.
“We are excited to begin this study at the Brooke Army Medical Center in San Antonio, Texas,” said Peter G. Traber, M.D., Galectin’s president, chief executive officer and chief medical officer. “We know from the scientific literature that galectin-3 is at higher levels in the skin of psoriasis patients, and that GR-MD-02 inhibits galectin-3. It would follow that GR-MD-02 could affect this disease. We are hopeful that patients with moderate-to-severe plaque psoriasis will show a clearing of their disease without the negative side effects associated with many of the currently available therapies. In addition, a successful pilot study would add to our robust therapeutic pipeline for this compound.”
Psoriasis, which manifests most often as plaque psoriasis, is a chronic, relapsing, inflammatory skin disorder. Although plaque psoriasis is rarely life threatening, it often is intractable to treatment. According to the International Federation of Psoriasis Associations, about 3% of the world’s population has some form of psoriasis. In the U.S. there are about 150,000 new cases every year, and psoriasis affects about 2% of the population, according to the Cleveland Clinic.
About the Psoriasis Study
This study is a Phase 2a open-label trial in patients with moderate-to-severe plaque psoriasis in which 10 psoriasis patients with >= 10% of their skin affected and a PASI (psoriasis activity and severity index) of >= 12 points will be treated with 8 mg/kg of GR-MD-02 every other week for a total of seven infusions. The primary endpoint will be the PASI-75, or a 75% improvement in the severity of the disease 30 days following the final infusion. More information on the trial can be found in a CEO Perspective published today, which can be found here.
About GR-MD-02
GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease and fibrosis. Galectin-3 plays a major role in diseases that involve scaring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. The drug binds to galectin proteins and disrupts their function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.
About Galectin Therapeutics
Galectin Therapeutics is developing promising carbohydrate-based therapies for the treatment of fibrotic liver disease and cancer based on the Company’s unique understanding of galectin proteins, which are key mediators of biologic function. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. The Company is pursuing a development pathway to clinical enhancement and commercialization for its lead compounds in liver fibrosis and cancer. Additional information is available at www.galectintherapeutics.com.
SOURCE: Galectin Therapeutics
Post Views: 57
