CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that the FDA'sBlood
Products Advisory Committee (BPAC) rendered a positive opinion on the
proposed hemostatic efficacy and safety endpoints for a potential U.S.
Phase III clinical trial of the INTERCEPT Blood System for platelets.
The Committee disagreed with the safety margins for the trial proposed
by Cerus, and recommended that the trial design include more stringent
safety margins for comparing INTERCEPT-treated platelets and
conventional platelets. In addition, the Committee rendered a positive
opinion on a proposed pathway forward in which successful completion of
the proposed Phase III trial would be followed by a post-marketing
randomized control study and concurrent staged roll-out of the product.
"The Committee's guidance supports further development of INTERCEPT in
the United States," said Claes Glassell, president and chief executive
officer of Cerus. "We now need to conduct further discussions with the
FDA to agree upon a final protocol. The more stringent safety margins
recommended by the Committee may require a clinical trial with a larger
number of patients than had been proposed. We expect that it will take
at least 12 months to complete the clinical trial preparations and
partnering arrangements necessary for commencement of the potential
trial."
The proposed Phase III clinical trial is designed as a randomized,
double-blinded, non-inferiority trial to assess the hemostatic efficacy
and safety of routine use of INTERCEPT-treated platelets compared to
platelets prepared with conventional processes. The proposed primary
efficacy endpoint is number of days of Grade 2 bleeding (World Health
Organization scale), and the proposed primary safety endpoint is the
incidence of acute lung injury (ALI).
Previously, Cerus completed a U.S. Phase III trial for INTERCEPT-treated
platelets, the SPRINT trial, which enrolled 645 patients. The SPRINT
trial met its primary endpoint of the proportion of patients with Grade
2 bleeding, indicating non-inferiority of INTERCEPT platelets compared
to conventional platelets. While acknowledging this outcome, the FDA
expressed concerns regarding observed differences between the test and
control arms of the study and had indicated that it needed more data to
support a pre-market approval application. The new Phase III trial will
be designed to resolve the FDA's questions regarding hemostatic efficacy
and safety.
The FDA seeks the advice of an advisory committee such as the BPAC when
evaluating a potential new product. A final decision is made by the FDA
and while the FDA is not required to follow the advice of its advisory
committee, it often does.
ABOUT THE INTERCEPT PLATELET SYSTEM
The INTERCEPT Blood System for platelets is designed to reduce the risk
of transfusion-transmitted diseases by inactivating a broad range of
pathogens such as viruses, bacteria and parasites that may be present in
donated blood. The nucleic acid targeted mechanism of action allows
INTERCEPT treatment to inactivate both historical transfusion threats,
such as hepatitis, HIV and bacteria, as well as emerging pathogens such
as influenza, West Nile virus, malaria and dengue. The platelet system
was granted CE mark registration in 2002, and subsequently received
additional European regulatory approvals in France (Afssaps),
Switzerland (Swissmedic), and Germany (Paul Ehrlich Institute marketing
authorization for the German Red Cross). Over 300,000 units of INTERCEPT
platelets have been successfully transfused to date.
ABOUT CERUS
Cerus Corporation is a biomedical products company focused on
commercializing the INTERCEPT Blood System to enhance blood safety.
Cerus currently markets and sells the INTERCEPT Blood System for both
platelets and plasma in Europe, Russia, the Middle East and selected
countries in other regions around the world. The INTERCEPT red blood
cell system is in clinical development. See http://www.cerus.com
for more information.
INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.
This press release contains forward-looking statements. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements,
including, without limitation, statements relating to potential FDA
agreement on the trial design for, and the potential commencement of, a
U.S. Phase III clinical trial of INTERCEPT platelets, Cerus'
expectations regarding the length of time required to complete potential
partnering arrangements and other actions necessary for the commencement
of the potential U.S. Phase III clinical trial, other potential
development and U.S. regulatory actions or events related to INTERCEPT
platelets, including continued development of INTERCEPT platelets in the
U.S., and Cerus' ability to resolve the FDA's concerns regarding safety
and efficacy. Actual results could differ materially from these
forward-looking statements as a result of certain factors, including,
without limitation, risks associated with BPAC recommendations relating
to the proposed trial design and overall proposed regulatory pathway,
FDA's lack of obligation to follow BPAC recommendations, Cerus' ability
to reach agreement with the FDA on the proposed trial design, Cerus'
need for additional funding from partners or other sources in order to
conduct the potential Phase III clinical trial and its ability to obtain
that funding or to complete any partnering arrangements or both, the
absence of which would preclude any commencement of the potential Phase
III clinical trial, whether the number of patients required to be
enrolled in the potential Phase III clinical trial or in any
post-marketing study would be prohibitively large due either to cost,
logistics or both, Cerus' ability to enroll an adequate number of
patients in the potential Phase III clinical trial in a timely manner or
at all, whether data collected in such a trial will be adequate to
address FDA concerns regarding the safety and efficacy of INTERCEPT
platelets, and risks associated with conducting clinical trials,
including the risk of failure, delays and required changes in the
clinical trial design even if original objectives are being met, as well
as other risks detailed in the Cerus' filings with, the Securities and
Exchange Commission (SEC), including in Cerus' quarterly report on Form
10-Q for the quarter ended September 30, 2009, filed with the SEC on
November 6, 2009. No pathogen inactivation system has been shown to
inactivate all pathogens. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the date of
this press release. Cerus does not undertake any obligation to update
any forward-looking statements as a result of new information, future
events, changed assumptions or otherwise.
Source: Cerus Corporation