LONDON ¿ In the face of previous high-profile failures in the treatment of sepsis, Therapeutic Antibodies Inc (TAB) said it is seeking a pharmaceutical partner in that indication for its CryoTAb polyclonal antibody, following a successful Phase IIb trial.
The study in 81 patients showed a statistically significant reduction in the amount of time patients spent on ventilation and in intensive care. The randomized, placebo-controlled trial was to determine if treatment with CryoTAb for five days would protect patients from additional injury caused by tumor necrosis factor-alpha (TNF-alpha) released in response to infection, and hasten recovery from organ failure.
Gordon Bernard, who conducted the study at Vanderbilt University in Nashville, Tenn., said the results exceeded expectations. ¿The magnitude of the observed beneficial effects, primarily the reduction in time spent on a ventilator and in the ICU, was greater than anticipated considering the relatively small sample size,¿ he said.
The endpoint for a Phase III trial would be patient mortality. ¿We are very much aware of the history of [clinical trials in] sepsis,¿ James Christie, operations director of TAB, told BioWorld International. ¿But our data is very good, and we have had it independently assessed, so we want to move forward with caution¿.
That will involve being very selective about the patients recruited to any trial and administering CryoTAb within 24 hours of onset symptoms. ¿However the trial is designed, we won¿t do it without a partner,¿ Christie said.
CryoTAb also is in Phase IIa studies in Crohn¿s disease.
TAB, which is headquartered in Tennessee, but quoted in London, released the results of the CryoTAb sepsis study last month as it announced plans to merge with Proteus International plc, of Macclesfield, Cheshire.
At the same time, Proteus gave a progress report, indicating that its Angiotensin vaccine for hypertension has entered Phase I trials. The company also reported financial results for the year that ended March 31, 1999, in which losses fell to #3.9 million from #4.1 million. Revenues increased to #696,000 from #178,000. Research and development expenditures were up at #5.1 million from #4.5 million. The company had cash and equivalents of #7.4 million.