Ligand Announces Initiation of Clinical Trials for Thrombocytopenia Drug, LGD 4665
Ligand Pharmaceuticals Incorporated announced that the Company is initiating Phase I clinical trials of LGD 4665, an oral, small molecule drug that mimics the activity of thrombopoietin (TPO), a growth factor that promotes growth and production of blood platelets.
Thrombocytopenia or low platelet count is a common clinical finding associated with a diverse group of clinical disorders or conditions affecting platelet production and/or survival. Prevalent clinical disorders where platelet loss or dysfunction leads to significant morbidity include idiopathic thrombocytopenia purpura (ITP), myelodysplastic syndrome, liver dysfunction associated with hepatitis C viral and severe cirrhosis, chemotherapy-induced thrombocytopenia (CIT) as well as a number of other disorders. Current therapeutic options are mostly palliative, including steroids, immunosuppresants, splenectomy and, for the most severe thrombocytopenias, platelet transfusion.
ARROW'S HEPATITIS C TREATMENT ENTERS PHASE I STUDY
Arrow Therapeutics has begun a Phase I study of A-831, a small-molecule antiviral inhibitor of the hepatitis C virus. The study will evaluate the safety, tolerability and pharmacokinetics of single escalating doses of A-831 in healthy volunteers in the UK.
A-831 targets the NS5a protein, a novel mechanism of action, and is the first NS5a inhibitor to enter clinical trials. The drug showed good safety and pharmacokinetics in preclinical studies and excellent potency in the replicon assay. A-831 is the first compound from Arrow's broad approach to the NS5a target.
The current standard treatment for hepatitis C, pegylated interferon plus ribavirin, has a poor side effect profile and is only effective in around 50 percent of patients, according to Arrow. Patients often need multiple drugs in combination therapy to overcome drug resistance.
The company also plans to develop other drugs for hepatitis C, which will be licensed to other companies between the preclinical and Phase IIb stages.
SEATTLE GENETICS BEGINS TRIAL OF HODGKIN'S LYMPHOMA DRUG
Seattle Genetics has initiated a Phase I clinical trial of SGN-35 for patients with Hodgkin's lymphoma and other CD30-positive hematologic malignancies. SGN-35 is an antibody-drug conjugate (ADC) that utilizes Seattle Genetics' proprietary technology to empower antibodies by linking them to potent cell-killing drugs.
The single-agent, dose-escalation study is designed to evaluate the safety, pharmacokinetic profile and antitumor activity of SGN-35 in patients with relapsed or refractory CD30-positive hematologic malignancies, including Hodgkin's lymphoma. The trial is expected to enroll up to approximately 40 patients at multiple centers in the United States.
SGN-35 is an ADC composed of an anti-CD30 antibody joined by an enzyme-cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells, resulting in a targeted cell-killing effect. Treatment with SGN-35 resulted in complete tumor regressions in preclinical models of Hodgkin's disease and anaplastic large-cell lymphoma.
Pain Therapeutics Announces Positive Phase I Study Results With PTI-202
Pain Therapeutics, Inc. announced positive results from a Phase I clinical trial evaluating PTI-202, the Company's second abuse- resistant opioid painkiller.
This clinical trial was designed to investigate the safety, tolerability, pharmacokinetics and pharmacodynamic profile of a single, oral dose of PTI-202 in healthy volunteers. We believe results also indicate PTI-202 is safe and well-tolerated and its release profile appears well-suited to use with a chronic pain population. There were no unexpected adverse events in this trial.
PTI-202 is a novel abuse-resistant formulation of an opioid painkiller. Its active pharmaceutical ingredient remains undisclosed. PTI-202 is intended to meet the needs of physicians who appropriately prescribe opioid painkillers and who seek to minimize the risks of drug diversion, abuse or accidental patient misuse.
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