Expert opinion on investigational drugs
-
Expert Opin Investig Drugs · May 2009
ReviewSpinal cord injury and neural repair: focus on neuroregenerative approaches for spinal cord injury.
This review discusses the urgent need for improved therapeutic approaches aimed at restoring function following traumatic spinal cord injury (SCI). The focus of this paper is neuroregenerative approaches for SCI, with a highlighted comparison of recent advances in the field and comparisons to that made by Cethrin (Alseres Pharmaceuticals, Inc.), the leading nerve repair product. ⋯ In a recently concluded Phase I/IIa clinical trial involving 37 patients with either cervical or thoracic SCIs, the evidence for Cethrin indicates that topical administration of either 0.3, 1, 3 or 6 mg of the recombinant rho inhibitor following surgical decompression is safe. Alseres has announced that planning is underway for a Phase IIB trial of Cethrin to include a placebo arm to assess better the drugs' clinical efficacy.
-
Expert Opin Investig Drugs · Apr 2009
ReviewAurora kinase inhibitors in preclinical and clinical testing.
Mitosis is a key step in the cell cycle governing the distribution of genetic material to the daughter cells. Any aberration in this process could lead to genomic instability. Aurora A, B and C, are members of the serine/threonine kinase family. Aurora kinases are essential for spindle assembly, centrosome maturation, chromosomal segregation and cytokinesis during mitosis. Abnormalities in the mitotic process through overexpression/amplification of aurora kinase have been linked to genomic instability leading to tumorigenesis. Hence, use of aurora kinase small molecule inhibitors as potential molecular-targeted therapeutic intervention for cancer is being pursued by various researchers. ⋯ Pubmed, Scifinder and (www.clinicaltrials.gov) databases were used to search the literature for aurora kinase. CONCLUSION/RESULTS: Approximately 13 aurora kinase inhibitors are under Phase I/II evaluation at present for various cancers of different origins; and several others are in preclinical testing. Details of their preclinical/clinical results and important considerations for future aurora kinase inhibitor development are discussed. Considering the fact that aurora kinase plays an important role in the mitosis process and is involved in tumorigenesis, development of aurora kinase inhibitors for the treatment of cancer, either as a single agent or in combination with existing cancer treatment is warranted.
-
Expert Opin Investig Drugs · Mar 2009
ReviewOpioid formulations in development designed to curtail abuse: who is the target?
Opioids are increasingly prescribed for chronic cancer and noncancer pain, and misuse, abuse, and diversion have risen dramatically. Formulations are being developed with the intent to curtail abuse through physical barriers that resist alteration, inclusion of excipients that antagonize opioid effects when altered, and other technologies. ⋯ Emerging opioid formulations may prove useful to minimizing prescription opioid abuse, but the magnitude of their clinical utility and societal impact will be unknown until epidemiological studies can be conducted. Realistic expectations for what the new formulations can achieve are encouraged.
-
This perspective is part of an annual series of papers discussing drugs dropped from clinical development in the previous year. Specifically, this paper focuses on the 28 oncology drugs discontinued in 2007. Information for this perspective was derived from a search of the Pharmaprojects database for drugs discontinued after reaching Phase I - III clinical trials.
-
Expert Opin Investig Drugs · Nov 2008
Clazosentan: an endothelin receptor antagonist for treatment of vasospasm after subarachnoid hemorrhage.
Clazosentan (Ro 61-1790, VML-588 or AXV-034) is under study in clinical trials for the treatment of patients with aneurysmal subarachnoid hemorrhage (SAH) by Actelion Pharmaceuticals. It is a synthetic endothelin (ET) A receptor antagonist that decreases and reverses cerebral vasospasm after experimental SAH. ⋯ This study (CONSCIOUS-2) will enroll approximately 765 patients randomized 2:1 to clazosentan 5 mg/h intravenously or placebo. All patients will undergo neurosurgical aneurysm clipping and outcome will be assessed primarily based on mortality and vasospasm-related morbidity.