PATH completes phase 3 (b) of Bangladesh clinical trial

International non-profit organisation PATH has completed phase 3 (b) of a new clinical trial in Bangladesh, where they are investigating the antibiotic Paromomycin Intramuscular Injection (PMIM).

It has been developed in an effort to treat visceral leishmaniasis (VL or kala-azar), with the work looking at the safety and efficacy of PMIM mono-therapy across 120 patients in areas of the country where the disease is present.

The trial's first patient was enrolled in January 2011 and, since then, government-run public health centres, expert researchers and scientists at the Centre for Communicable Diseases have worked together to improve understanding of the deadly illness.

VL is an infectious disease that is transmitted through the bite of a sand fly and can go on to affect visceral organs, leading to chronic fever, weight loss and anemia.

In an effort to combat VL, PMIM was developed by OneWorld Health and the treatment has been recommended by the World Health Organisation as the preferred combination therapy to treat the disease in South Asia.

As well as this, PMIM is registered with drug regulatory agencies in India, Nepal and Uganda.

Dr Ponni Subbiah, global program leader for PATH’s drug development group, said: "Our model for administering PMIM in this study allowed patients to receive testing and treatment in an outpatient setting. This has worked well for those patients who live in rural and remote areas where VL is endemic.

"It is wonderful to know that the drug we developed can contribute to the ongoing efforts to evaluate, strengthen, and expand the arsenal of available treatments for VL."

Elsewhere in the pharma world, Avaxia Biologics Inc recently announced the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for AVX-470.

The biotechnology company engineers oral antibody drugs and this consent will allow it to use AVX-470 in trials for ulcerative colitis treatment.

AVX-470 is an anti-TNF (tumour necrosis factor) polyclonal antibody and is the first clinical contender to emerge from the business' oral antibody platform.

Posted by Ben Evans