Molecular Insight stock leaps nearly 200% on strong new Phase II Onalta data

Massachusetts, USA-based Molecular Insight Pharmaceuticals saw its share price rocket nearly 200% to $4.43 in pre-market trading yesterday, after the company announced results from a completed Phase II clinical trial of its cancer drug candidate Onalta (yttrium-90 edotreotide) have been published in the Journal of Clinical Oncology (JCO). Results from the study of 90 patients show that treatment with Onalta improved symptoms associated with metastatic carcinoid tumors.

Patients enrolled in the Phase II clinical study suffered from malignant metastatic carcinoid tumors (neuroendocrine tumors of the gastro-intestinal tract and bronchus) and were refractory to conventional treatment with the somatostatin analogue, octreotide. Y-90-edotreotide therapy resulted in objective tumor response or stable disease in 67 (74.4%) of 90 patients with metastatic carcinoid refractory to octreotide therapy. Median progression-free survival and overall survival were 16.3 and 26.9 months, respectively. Furthermore, there appeared to be a correlation with prolongation of the period of progression free survival in those patients who had durable diarrhea improvement (P =.031).

Improvements in symptoms and QTL

Key improvements in patient symptoms and quality-of-life related to carcinoid tumors were also noted. Symptoms of patients with carcinoid tumors include severe diarrhea, hot flushes and abdominal pain, among others. Among symptomatic patients, a trend toward improvement for each specified symptom was consistently demonstrated and statistically significant across all symptoms. Quality of life included assessments of anxiety, depression, pain and discomfort, among others. In addition, treatment was well-tolerated and had an acceptable adverse event profile.