EASTLAND Medical Systems shares took a battering yesterday, despite the announcement of positive results from a small trial of the company?s under-the-tongue malaria treatment.
Eastland dropped down 13.9% or 1.2c to 8.1c yesterday on the release of Phase 2a results from a Rwanda clinical field trial.
Some 3.8 million shares changed hands ? a significantly higher volume than the previous five trading days.
This morning 1.1 million shares had changed hands by midday and the share price dropped down a further 12.7% to 6.9c.
The trial tested the company?s ArTiMist treatment against intravenous quinine, with half the patients in the open label trial randomised into ArTiMist treatment and half treated with intravenous quinine.
Eastland chief executive Dermot Patterson told BTN the 30-patient open label study met its endpoints, though the company was still waiting for its final data pack.
?The protocols and endpoints were met,? he said.
?The results showed a significant parasite reduction within 24 hours which was in line with our expectations.?
The ClinicalTrials.gov-registered trial measured parasitological success as its primary endpoint and defined this as a reduction in parasite count of =90% of baseline at 24 hours after the first dose.
The first secondary endpoint measured parasite reduction ratio at 12 hours and 24 hours, while the second looked at parasite clearance time (at 3, 6, 12, 18, 24, 30, 36, 48, 54 and 60 hours).
What phase?
The trial was originally planned as a Phase 3 trial; however, the company decided at some point in the last 18 months to shift to a smaller Phase 2 trial. Eastland has consistently said it planned to move from a Phase 1 to a full Phase 3, quietly changing its trial strategy at some point last year.
In a presentation released to the Australian Securities Exchange in April 2008, ArTiMist creator Calvin Ross said a planned Phase 3 trial would enrol 300 patients, and in November 2008 the company indicated Phase 3 trials for ArTiMist would start soon.
A Patersons research note from June 19 last year, released to the ASX on that day, said Phase 3 clinical field trials were set to commence shortly.
The note was released during a Patersons-underwritten capital raising to support the company?s clinical program, but the prospectus did not specify the phase of those clinical field trials.
Announcements from the second half of last year and this year called the Rwanda study a ?clinical field trial? but did not mention its phase.
Patterson told BTN yesterday that at some point in the last 18 months the company had decided to complete a Phase 2a study before it moved on to Phase 3 research.
?Post Phase 1 we decided that what we would look to do is a small Phase 2a which is also to help just ensure we validate our assumptions,? he said.
Patterson told BTN the company had decided to make the Rwanda trial a Phase 2a, rather than a Phase 3, after receiving advice.
?We have been in the throes of setting this up, going back to over a year ago,? he said.
?We decided along with Calvin [Ross] and other clinical advisers that that was the best way to approach it.?
Eastland has appointed a new commercialisation partner, AFG Ventures Group, as it moves towards commercialisation for ArTiMist.
Patterson said the company was now on a path to begin a 100-patient Phase 2b/3 study, expecting to fund that in part with the sale of a subsidiary which is currently on the market and has a number of interested parties.
- sourced from biotechnologynews.net
EMS Price at posting:
7.0¢ Sentiment: LT Buy Disclosure: Held
