Biota Initiates Dosing in Phase 2 IGLOO Trial of LANI in the Northern Hemisphere
December 05 2013 - 8:02AM
Biota Pharmaceuticals, Inc. (Nasdaq:BOTA) (the "Company") today
announced that it has commenced dosing patients in the Northern
Hemisphere portion of its ongoing Phase 2, randomized, double
blind, placebo controlled, parallel arm clinical trial of
laninamivir octanoate (LANI). The trial, referred to as "IGLOO",
compares the safety and efficacy of 40 mg and 80 mg of LANI with
placebo, all delivered by a TwinCaps® inhaler in adults with
presumed influenza A or B infection. The trial was initiated in the
Southern Hemisphere in June and is now continuing in multiple
countries in the Northern Hemisphere. The Company's goal is to
complete enrollment in the IGLOO trial by the end of the influenza
season in the Northern Hemisphere and have top-line data available
in mid-2014. IGLOO is being conducted in connection with the
Company's contract with the U.S. Office of Biomedical Advanced
Research and Development Authority ("BARDA"). Further details
regarding the design of IGLOO are available at
www.clinicaltrials.gov.
About Biota
Biota Pharmaceuticals, Inc. is a biopharmaceutical company
focused on the discovery and development of products to prevent and
treat serious and potentially life-threatening infectious diseases.
The Company currently has two Phase 2 clinical-stage product
candidates: LANI, a long-acting neuraminidase inhibitor that the
Company is developing for the treatment of influenza A and B
infections under an IND in the U.S. and through a contract with
BARDA that is designed to provide up to $231 million in financial
support to complete its clinical development; and vapendavir, a
potent, oral broad spectrum capsid inhibitor of enteroviruses,
including human rhinovirus (HRV). In addition to these
clinical-stage programs, the Company has a preclinical program
focused on developing treatments for respiratory syncytial virus
(RSV). For additional information about the Company, please visit
www.biotapharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve known and unknown risks and uncertainties. All
statements, other than historical facts, including statements
regarding the anticipated time in which the Company expects to
complete enrollment and have top-line data from the ongoing Phase 2
IGLOO trial, are forward looking statements. Various important
factors could cause actual results, performance, events or
achievements to materially differ from those expressed or implied
by the forward-looking statements, including: the Company, BARDA,
the FDA or a similar regulatory body in another country, a data
safety monitoring board, or an institutional review board,
delaying, limiting, suspending or terminating the clinical
development of LANI at any time for a lack of safety, tolerability,
anti-viral activity, commercial viability, regulatory or
manufacturing issues, or any other reason whatsoever; BARDA
terminating or significantly amending the Company's existing
contract to develop LANI; a prolonged shutdown of the U.S.
government or other actions by the U.S. government that could delay
or suspend the development of LANI; the Company's ability to comply
with extensive government regulations in various countries and
regions in which it expects to conduct its clinical trials; the
Company's ability to secure, manage and retain qualified
third-party clinical research, preclinical research, data
management and contract manufacturing organizations which it relies
on to assist in the design, development and implementation of the
clinical development of LANI; the Company's ability to recruit and
manage multi-national clinical trials; the severity and seasonality
of influenza in regions where the Company is conducting its
clinical trials of LANI; and other cautionary statements contained
elsewhere in this press release and in the Company's Annual Report
on Form 10-K for the year ended June 30, 2013, as filed with the
U.S. Securities and Exchange Commission, or SEC, on September 27,
2013 and in the Company's Quarterly Report on Form 10-Q for the
quarters ended September 30, 2013, as filed with the SEC on
November 12, 2013.
There may be events in the future that the Company is unable to
predict, or over which it has no control, and the Company's
business, financial condition, results of operations and prospects
may change in the future. The Company may not update these
forward-looking statements more frequently than quarterly unless it
has an obligation under U.S. Federal securities laws to do so.
Biota is a registered trademark of Biota Holdings Limited and
TwinCaps® is a registered trademark of Hovione FarmaCiencia SA.
CONTACT: Russell H. Plumb
Chief Executive Officer
(678) 221-3351
r.plumb@biotapharma.com
Lee M. Stern
The Trout Group
(646) 378-2922
lstern@troutgroup.com
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