BioSante Pharmaceuticals,
Inc. (NASDAQ: BPAX – News)
today announced presentation of results from a Phase Ib clinical study that show
its GVAX Pancreas cancer
vaccine increased the median survival of pancreatic cancer patients with
previously treated, locally advanced or metastatic pancreatic adenocarcinoma
(PDA), from 3.3 months when treated with ipilimumab (IPI; Yervoy; BMS), to 5.5
months on the combination of IPI plus GVAX Pancreas, an increase of more than 60
percent. The study was not powered for a direct comparison. In addition, the
IPI/GVAX Pancreas combination demonstrated an increase in one year survival,
from 7 percent to 27 percent. A new multicenter clinical study is planned to
begin this year.
A poster titled, “Phase 1b Study of Ipilimumab Alone or in Combination with
Allogeneic Pancreatic Tumor Cells Transfected with a GM-CSF Gene in Pancreatic
Cancer,” was presented at the 2012 Gastrointestinal Cancers Symposium by Dung T.
Le, et al, lead investigator at Johns Hopkins University. The abstract of the
poster is in the Journal of Clinical Oncology 30, 2012 (suppl 4; abstr 211). The
primary endpoint was to determine the safety profile of IPI alone or in
combination with GVAX and the secondary endpoints were overall survival and
toxicity, and the induction of mesothelin specific T cell responses. Toxicities
were manageable. In addition, the postimmunotherapy induction of
mesothelin-specific T cells in patients correlates with disease-free survival.
The investigators concluded that, “Immunotherapy has potential even in advanced
PDA.”
The 30 patient Phase Ib study was conducted by researchers at the Sidney
Kimmel Cancer Center of Johns Hopkins University School of Medicine and the
Bloomberg School of Public Health at Johns Hopkins, in Baltimore, Maryland. BioSante’s
Pancreas cancer vaccine is made from allogeneic pancreatic cancer cells
genetically modified to produce an immune system stimulator, the cytokine
GM-CSF, and irradiated to prevent cell growth. BioSante already has received
Orphan Drug designation from the U.S. Food & Drug Administration for its
GVAX Pancreas cancer vaccine.
“We are very excited by the positive results of this study. This is
encouraging news concerning potential GVAX cancer vaccines, especially when combined with other
anticancer immunotherapies like IPI, for treatment of a disease that can be so
devastating for so many patients,” said Stephen M. Simes, BioSante’s president
& CEO. “Besides pancreatic cancer, Johns Hopkins researchers also are
investigating the use of BioSante’s cancer vaccines for the treatment of several
different forms of cancer, including leukemia, breast cancer, prostate cancer
and melanoma. We look forward to continuing our collaboration with this
well-respected research institute as further studies are conducted.”
About Pancreatic Cancer
About 95 percent of pancreatic cancer is adenocarcinomas. Patients with
pancreatic cancer have one of the poorest five-year survival rates of any form
of cancer with median survival around three to six months. Pancreatic cancer is
sometimes called a “silent killer” because it does not always cause noticeable
symptoms and most symptoms are non-specific and varied. It is for this reason
that pancreatic cancer often is not diagnosed until the disease is too advanced
for current treatment options to be effective. Therefore, in view of the current
poor patient prognosis, the need for novel and improved pancreatic cancer
treatments is urgent.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products
for female sexual health and oncology. BioSante’s products include
LibiGel® (transdermal testosterone gel) for the treatment of female
sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD),
which is in Phase III clinical development. BioSante also is developing a
portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials
currently on-going. Four of these vaccines have been granted Orphan Drug
designation by the U.S. Food and Drug Administration (FDA). BioSante’s other
products include Bio-T-Gel™, a testosterone gel for male hypogonadism, for which
a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which
is licensed to Teva Pharmaceuticals, and the Pill-Plus™, an oral contraceptive
in Phase II clinical development by Pantarhei Bioscience B.V. BioSante’s first
FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of
hot flashes associated with menopause, marketed in the U.S. by Jazz
Pharmaceuticals, BioSante’s licensee. Additional information is available online
at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with
information that is not historical, these are forward-looking statements under
the Private Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to, statements about future clinical studies and the potential of BioSante’s
GVAX cancer vaccines, and other statements identified by words such as “will,”
“continue,” “could,” “believe,” “intends,” “expects,” “anticipates,”
“plans,” “may,” “potential,” other words of similar meaning, derivations of such
words and the use of future dates. Forward-looking statements by their
nature address matters that are, to different degrees, uncertain.
Uncertainties and risks may cause BioSante’s actual results to be materially
different than those expressed in or implied by BioSante’s forward-looking
statements. For BioSante, particular uncertainties and risks include,
among others, the success of clinical testing, the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals and achieving
market acceptance; the success of BioSante’s licensees or sublicensees
and BioSante’s future revenues, if any, from its licensees and sublicensees;
uncertainties relating to the future and costs of BioSante’s product development
programs and its need for and ability to obtain additional financing if needed.
More detailed information on these and additional factors that could affect
BioSante’s actual results are described in BioSante’s filings with the
Securities and Exchange Commission, including its most recent annual report on
Form 10-K and subsequent quarterly reports on Form 10-Q. All
forward-looking statements in this news release speak only as of the date of
this news release and are based on BioSante’s current beliefs and
expectations. BioSante undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information, future events
or otherwise.
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