|Healthcare Review: Isis Pharmaceuticals, Halozyme Therapeutics, Oxygen Biotherapeutics, CytRx, MannKind Corp|
|By Staff and Wire Reports|
|Monday, 31 March 2014 13:48|
Final analysis of Isis Pharmaceuticals' ($ISIS) antisense drug ISIS-APOCIII shows statistically significant reductions in triglycerides (64%) and apoC-III (71%) and apoC-III-associated VLDL in patients on stable doses of fibrates. Average increase of HDL-C is 52%.The 13-week Phase 2 study assessed the safety and activity of ISIS-APOCIII in 200 mg and 300 mg doses .Phase III to commence this year. Consensus total revenue estimates for Q1 and Q2 are $36.3M and $43.7M, respectively. Consensus total revenue estimates for 2014 and 2015 are $156M and $164M, respectively.
Halozyme Therapeutics' ($HALO) Hylenex treatment met the main goal of a trial in which a recombinant and a new formulation of the therapy were assessed. The study compared the use of Hylenex as a pretreatment for Type I diabetes patients receiving insulin injections compared with subjects who didn't receive pre-treatment. Hylenex achieved non-inferiority of hemoglobin A1C levels at six months, the primary endpoint. A1C indicates how much sugar is in the blood. Hylenex also reduced rates of hypoglycemia (low blood sugar), which the lead investigator of the study says is a key unmet need.
Oxygen Biotherapeutics ($OXBT) has received written confirmation that the FDA has lifted a hold on the clinical trials of the company's Oxycyte treatment for traumatic brain injury. The FDA had informed Oxygen Bio of its decision verbally earlier this month. Oxygen has been enrolling patients in Israel for a Phase IIb study to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury.
The European Commission has granted CytRx's ($CYTR) Aldoxorubicin therapy orphan medicinal product designation for the treatment of advanced soft-tissue sarcomas, a cancer that occurs in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue. The classification adds to U.S. orphan designation. Aldoxorubicin is in a Phase III trial of patients whose tumors have progressed following treatment with chemotherapy.
Shares of MannKind Corp. ($MNKD) are down 4% on modest premarket volume. The Endocrinologic and Metabolic Drugs Advisory Committee reviews AFREZZA's NDA tomorrow.