BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced additional
positive safety data in its ongoing LibiGel Phase III clinical
development program. For the second time, unblinded data have been
reviewed by the independent DMC of the LibiGel Cardiovascular and Breast
Cancer Safety Study. Based on this review, the DMC once again
unanimously recommended continuation of the study as described in the
FDA-agreed LibiGel safety study protocol, with no modifications.
“The DMC, which for the second time, reviewed the LibiGel safety data on
an unblinded basis, confirms what we have learned from the blinded data,
that LibiGel does not pose a safety risk to the women in the study”
BioSante reported that the DMC reviewed all unblinded adverse events in
the safety study including all “serious adverse events” and all “adverse
cardiovascular and breast cancer events” in almost 1,200 women-years of
exposure. To date, there have been no deaths, only six adjudicated
cardiovascular events and only four breast cancers reported. Therefore,
in view of the DMC recommendation, the BioSante LibiGel Phase III
development program will continue as planned. BioSante targets mid-2011
for submission to the FDA of a new drug application (NDA).
“Based on this second unblinded positive review by the DMC, we believe
that our safety study ultimately will provide the safety data needed for
our NDA submission and FDA approval of LibiGel,” said Michael Snabes,
M.D., Ph.D., BioSante’s vice president of clinical development. “We have
known, based on blinded data, and BioSante remains blinded, that the
rates of cardiovascular and breast cancer events in the study continue
to be significantly lower than expected in those women enrolled in the
safety study, all of whom are at the higher end of cardiovascular risk
for the intended population. If there was a negative effect of
testosterone, the cardiovascular rates would be higher. This
recommendation by the DMC supports our belief that LibiGel will be safe
for the treatment of female sexual dysfunction (FSD) in post-menopausal
women, our target patient population. This outcome represents another
significant positive advance for our LibiGel clinical development
program,” Dr. Snabes continued.
“The DMC, which for the second time, reviewed the LibiGel safety data on
an unblinded basis, confirms what we have learned from the blinded data,
that LibiGel does not pose a safety risk to the women in the study,”
said Stephen M. Simes, BioSante’s president and CEO. “A DMC can
recommend continuing, changing or stopping a study and their main
responsibility is to ensure that subjects recruited to the study are not
exposed to unnecessary safety risks. Therefore, the DMC’s recommendation
to continue the LibiGel safety study unchanged is the best possible
outcome of the DMC’s second unblinded review of all adverse events. This
is very good news for BioSante and for women since LibiGel remains the
lead pharmaceutical product in the U.S. in active development for the
treatment of hypoactive sexual desire disorder (HSDD) in surgically
menopausal women. We continue to believe that LibiGel can be the first
product approved by the FDA for this common and unmet medical need, also
referred to as female sexual dysfunction (FSD).”
The Phase III Cardiovascular and Breast Cancer Safety Study is a
randomized, double-blind, placebo-controlled, multi-center,
cardiovascular events and breast cancer study that will enroll between
2,400 and 3,100 women, exposed to LibiGel or placebo for 12 months. An
NDA can be submitted and reviewed by FDA, possibly leading to approval
of LibiGel, at that time. After NDA submission and potential approval of
LibiGel, BioSante will continue to follow the women enrolled in the
study for an additional four years.