Clinical Trial ReportsPHASE IAdherex Initiates Combination Trial of ADH-1 and Melphalan for Melanoma Treatment
Adherex Technologies Inc. initiated a phase I trial of the combination of systemic ADH-1 plus isolated limb infusion melphalan for the treatment of melanoma. The study, which will be conducted at Duke University Medical Center, is expected to enroll up to 25 patients with N-cadherin positive melanoma and conclude in the second half of 2007, according to Adherex.
“Melanoma is a disease with an extremely poor prognosis,” said William P. Peters, MD, PhD, chairman and CEO. “Where the current treatment options are so limited, if our preclinical observations of significant and unexpected synergy of ADH-1 in combination with melphalan translate into humans, it would present the opportunity for an accelerated approval strategy and also the possibility for a major advance in the treatment of melanoma.”
The evaluation will explore escalating doses of ADH-1 in combination with standard doses of melphalan.Erimos Initiates Evaluation of First-In-Class Small Molecule Therapy for Glioma Brain Tumors
Erimos Pharmaceuticals announced that patient dosing has commenced for its lead product candidate, terameprocol (EM-1421), for the treatment of recurrent, highgrade glioma brain tumors that are unresponsive to conventional therapy.
“Although major progress has been made in understanding how to treat brain tumors, we are very excited to have the opportunity to add a potential new treatment for this distressing disease, especially one that appears to have such low toxicity,” said Stuart A. Grossman, MD, study chairman.
Terameprocol, a derivative of nordihydroguaiaretic acid, is a novel chemical entity exclusively licensed from The Johns Hopkins University. This first-in-class small molecule drug is designed to target abnormal tumor cells while causing little or no toxicity to healthy cells, according to Erimos. It is designed to prevent the production and activation of survivin, a protein that is produced excessively in tumor cells, thus preventing cell replication and enhancing the body’s ability to eliminate abnormal cells through apoptosis.
The open-label, phase I/II study is designed to determine the safety and maximum tolerated dose of terameprocol when administered to adult patients as well as to assess the anti-tumor activity of the regime. The trial will also investigate the pharmacokinetic properties of terameprocol. Approximately 30 adult patients will be enrolled and will be drawn from a population with progressive or recurrent glioma after primary treatment with surgery, radiation therapy and/or chemotherapy, and/or with no standard therapy available.
PHASE IIChemGenex Treats First Patient in CML Trial
ChemGenex Pharmaceuticals treated the first patient in a phase II/III study to evaluate whether Ceflatonin can provide clinical benefit to patients with chronic myeloid leukemia (CML) who have failed or are intolerant to tyrosine kinase inhibitor treatments (TKIs).
CML patients routinely receive treatment with imatinib mesylate (Gleevec) and dasatinib (Sprycel), TKIs that are approved in the US and Europe. Patients who are resistant or intolerant to the approved TKIs have limited treatment options, according to ChemGenex.
The CML-203 study is designed to evaluate the efficacy of Ceflatonin (homoharringtonine or HHT) in CML patients who have failed or were intolerant to treatment with two or more prior TKIs. It complements the ongoing CML-202 evaluation of CML patients with the T315I point mutation and will recruit CML patients from chronic, accelerated and blast-phase disease states.
“Initiation of the CML-203 study represents the achievement of another important milestone for ChemGenex,” said Greg Collier, PhD, ChemGenex’s managing director and chief executive officer. “This is a companion study to our ongoing CML-202 study, which will form the basis of our initial new drug application, or NDA. CML-203 should provide the basis for filing a supplementary NDA, thereby expanding the potential market for the drug.”
The first patient was enrolled into CML-203 at the M.D. Anderson Cancer Center in Houston, Texas. ChemGenex is expanding the study to an estimated 15 centers through the US and Europe. It anticipates that 50 to 75 patients will be enlisted into CML-203, and that initial data from the study will become available in the first half of 2008. The primary endpoint for the study will be hematologic response rate, and cytogenetic response rate will be one of the secondary endpoints assessed.Cleveland BioLabs Phase II Hormone-Refractory Prostate Cancer Trial Advances to Next Phase