Theraclone reports Phase IIa data for anti-flu mAb

Theraclone Sciences Inc. (Seattle, Wash.) said a single dose of TCN-032 given 24 hours after viral inoculation missed the primary endpoint of reducing the proportion of subjects with grade two or higher influenza symptoms or fever for seven days vs. placebo in a Phase IIa influenza A viral challenge trial (41.2% vs. 54.2%, p=0.21). TCN-032 -- a recombinant human mAb that binds to a conserved epitope of the amino-terminal extracellular domain (M2e) of M2 -- did meet several secondary endpoints, including significantly reducing median clinical symptom severity score by 35% vs. placebo and reducing viral shedding from the nasal mucosa by 2.2 log10 compared to placebo (p=0.095, with p>0.10 being the threshold for significance). The data came from 48 evaluable healthy volunteers. Data were presented at the Options for the Control of Influenza meeting in Cape Town.

Next half, the company plans to start a Phase IIa trial of TCN-032 in seriously ill hospitalized flu patients. The company, which is still working on a timeline to start a Phase IIb dose-ranging trial with TCN-032 in patients with uncomplicated influenza infection, is aiming to get a government contract to fund the rest of the Phase II program (see BioCentury, Sept. 9). ...