BTG's pipeline additions signify fortune turnaround
strategy it implemented last May by revealing its operating
highlights that has seen six new programmes added to its product
pipeline.
BTG have had an eventful year, which has seen a remarkable turnaround in the firm's fortunes, returning the company to a position of profitability and sustainable growth.
This is in contrast to 2004's global economic and political climates, which saw the company having to ride out tough economic conditions while continuing to invest in opportunities for creating future value.
2006 has seen six new programmes in-licensed during the year, including a series of selective EP4 receptor antagonists designed to treat conditions such as migraine headaches.
Its lead compound, BGC20-1531, is completing preclinical studies as it enters its first clinical study.
Louise Makin, Chief Executive Officer of >BTG told journalists in a press conference that an additional three acquisitions were made for its Drug Repositioning portfolio.
"These were two dermatology opportunities targeting head lice and fungal infections, and a novel oral formulation for an asthma product."
"In addition, two earlier stage programmes were in licensed for the oncology portfolio," she added.
BTG provided an update on its existing programmes revealing the enrolment was now complete for the phase II part of its phase I/II gastric cancer study of Plevitrexed (BGC 9331).
19 additional patients were expected to be dosed at the recommended level for follow-on studies.
Its Alzheimer's drug candidate, BGC20-1259 has now completed preclinical development and has just commenced a phase I clinical study. To date, two cohorts of eight volunteers have been treated with single ascending doses.
Dosing of the third cohort is expected to begin shortly, and planning for a multiple ascending dose study, which began mid-year, is under way.
BGC20-1259 is a multifunctional compound designed to act on the cognitive impairment, associated psychiatric symptoms such as depression and neurodegenerative aspects of Alzheimer's disease.
"In the current financial year we anticipate the completion of the plevitrexed (BGC9331) phase I/II, phase I for BGC20-1259 and the sleep apnoea proof of mechanism study," said Makin.
BTG revealed that several licensees had made solid progress with their development programmes. In particular, Genzyme's Campath, its 3rd line treatment for chronic lymphocytic leukaemia (CLL), reported positive results of a phase II trial comparing Campath with interferon beta-1a in multiple sclerosis.
Genzyme anticipates commencing phase III studies in MS in the second half of 2006.
BTG's research and focus into monoclonal antibodies gave the firm an opportunity to comment on the recent drug trial disaster that took place at London's Northwick Park Hospital in March.
The six volunteers had a severe reaction to the monoclonal antibody TGN1412. Several ended up in a critical condition.
Makin told DrugResearcher.com: "The events at Northwick Park have not effected or hindered our progress in monoclonal antibody treatments at all."
"If anything, we are finding that more people are coming forward to volunteer themselves as test subjects as a way to earn some extra money."
One of BTG's licensees Tolerex, showed in a phase II trial in new-onset type-1 diabetes that the monoclonal antibody TRX4 reduced the trial subjects' requirements for insulin over the 18 months of follow-up.
TRX4 was granted orphan drug status for this indication, which confers benefits including data exclusively if successfully approved.
Meanwhile Cougar Biotechnology progressed its European phase I study of abiraterone acetate, an inhibitor of testosterone biosynthesis targeting prostate cancer, and was granted approval to commence clinical studies in the US.
Also Abiogen Pharma completed phase I studies of ABIO 08-01 (BTG1640) and is currently planning a phase II proof of concept study in anxiety.
