AMD therapies in Phase III

November 29, 2007

Take a look at the therapies that have reached Phase III clinical testing.

                                   

Retaane (Alcon): Cortisone

Retaane (anecortave acetate) ophthalmic solution belongs to the class of drugs known as cortisones, which act to prevent the growth of blood vessels. Retaane is currently being investigated in the Anecortave Acetate Risk-Reduction Trial (AART), as a method for reducing the risk for the progression of dry AMD to wet AMD.

Alcon recently decided to suspend the investigation of Retaane as a treatment for wet AMD.

VEGF Trap (Regeneron Pharmaceuticals/Bayer Healthcare): Anti-VEGF

VEGF Trap is a fully human, soluble VEGF receptor fusion protein that binds all forms of VEGF-A and related placental growth factor. The Phase III trial, VIEW 1, is a randomized, double-masked study which aims to enrol approximately 1,200 patients at more than 200 centres across the US and Canada. It will evaluate the drug' efficacy and safety at doses of 0.5 mg and 2.0 mg administered at four-week intervals and 2.0 mg at eight-week intervals, compared with 0.5 mg of ranibizumab (Lucentis) administered every four weeks.

In a Phase II trial, the drug met its primary endpoint of a statistically significant reduction in retinal thickness 12 weeks from baseline. There was also a statistically significant improvement in visual acuity, with all subjects increasing by a mean of 5.9 letters. No drug-related serious adverse events were reported.

Bevasiranib (Opko Health): siRNA

Bevasiranib is a first-in-class small interfering RNA (siRNA) drug designed to silence the genes that produce VEGF. It is the first therapy, based on the Nobel Proze-winning RNA interference technology, to advance to Phase III clinical trials.

The Phase III COBALT (Combining Bevasiranib And Lucentis Thaerapy) multinational trial was initiated in July 2007 and aims to enrol more than 330 wet AMD patients. It will assess whether bevasiranib, administered every eight or 12 weeks, is safe and whether it has equivalent efficacy to Lucentis. In a Phase II trial of 129 patients at 28 sites across the US, bevasiranib was found to be safe at all teseted doses, well tolerated and most adverse events were mild and related to the administration procedure. No systemic adverse events were observed. Importantly, pharmacokinetic studies confirmed that there was no systemic bevasiranib exposure in patients, an important factor for agents targeting VEGF.

RHEO procedure (OccuLogix): Apheresis

In November 2007 OccuLogix announced that, following a comprehensive review of the costs and development time-lines associated with the products in its portfolio and, in light of the Company's current financial position, it has indefinitely suspended its RHEO System clinical development programme.

The RHEO procedure is a specific method of apheresis-a treatment in which a patient's blood is drawn outside the body and specific compounds are removed before being returned to the body.

The RHEO procedure uses patented filtering technology to remove excess levels of macro-proteins and fatty components in the blood that have been associated with AMD. These substances, which are known to thicken the blood, decrease blood flow and cause damage to capillary vessels, included LDL cholesterol, fibrinogen and alpha-2-macroglobulin.