Here's the full article.
PRIMA BioMed has landed a $25.5 million convertible note facility
to fund its clinical trial program for ovarian cancer treatment CVac,
ending any uncertainty over whether the product will be tested in
a larger patient group.
The convertible notes, which will be drawn down in
$700,000 tranches over the next three years, have
been offered to the company by New York-based
investment fund Springtree Special Opportunities Fund.
Prima will draw down $1 million of the notes over the
next two weeks and then take another $700,000
tranche every 30 days, to a total of $25.5 million.
Unless Prima elects to repay the notes in cash, they will
automatically convert to Prima shares every month, valued at the lower of
130% (or 150% in some cases) of the average Prima closing price for the 20
business days before the date of this agreement – around 8c, by BTN’s
calculations – or 90% of the volume-weighted average share price for the fiveday
period immediately before the relevant repayment date.
Prima said that, as the convertible note repayments were based on an
assumed capital appreciation of its shares, they would carry no additional
interest, unless the company defaulted on the terms. Prima will need to take
the funding deal to its shareholders once the share conversions get past the
15% threshold.
Clinical trial program
Prima says the funding will initially be used to kick off a Phase 2b trial for
CVac, expected to begin sometime in the fourth quarter of this year.
Prima executive director Martin Rogers told BTN this morning that the company
had agreed to trial protocols with the US Food and Drug Administration, but
was still sorting through manufacturing issues. As the company is intending to
establish both US and Australian manufacturing facilities for the two arms of
the trial, it needs to develop rigorous testing protocols to assure the FDA that
exactly the same product will be delivered across the entire trial.
Rogers said the Phase 2b trial had been designed so it could be enlarged into a
full-blown Phase 3 pivotal trial if early results justified its expansion.
Background
CVac is a vaccine therapy treatment for ovarian cancer administered postsurgery
and post-chemotherapy to delay relapse and control metastases. CVac
consists of a patient's own dendritic cells primed with a tumour antigen (Mucin-
1) and an adjuvant, mannan fusion protein (M-FP).
M-FP refers to the form in which the target protein of the CVac immunotherapy
is presented to the immune system. The mannan used is a chain of mannose
molecules that is oxidised and linked to the cancer protein (Mucin-1). Mannan
stimulates the immune system and it is the mannan that results in rapid
uptake of Mucin-1 into the dendritic cells of the immune system via the
mannose receptor on the cell surface.
Once the M-FP is inside the dendritic cell, enzymes digest the Mucin-1 and
fragments of Mucin-1 are presented on the dendritic cell surface. This
presentation results in the stimulation of certain cells of the immune system to
target Mucin-1 on the surface of cancer cells.
CVac cleared Phase 2a trials in early 2007, but has since languished as Prima
struggled to raise money to complete its clinical trial program.
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