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BPAX gapped on news (COMTEX) B: BioSante's Prostate Cancer Vaccine Resulted in Stable Disease
in Over 50% of Patients in Newly Published Study ( Bus
B: BioSante's Prostate Cancer Vaccine Resulted in Stable Disease in Over 50% of
Patients in Newly Published Study ( BusinessWire )

LINCOLNSHIRE, Ill., Mar 05, 2012 (BUSINESS WIRE) --
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced
publication of results from a Phase I dose escalation clinical study
that show its GVAX Prostate cancer vaccine in treating metastatic
castration-resistant prostate cancer patients (mCRPC) in combination
with ipilimumab (Ipi; Yervoy; BMS), resulted in 53 percent of patients
achieving at least stable disease, with two patients showing clear
regression of metastases. In addition, 23 percent of patients in the
higher dose cohorts had confirmed partial PSA (prostate specific
antigen) responses of greater than 50 percent from baseline.

The study, titled, "Combined Immunotherapy with Granulocyte-Macrophage
Colony-Stimulating Factor-Transduced Allogeneic Prostate Cancer Cells
and Ipilimumab in Patients with Metastatic Castration-Resistant
Prostate
Cancer: a Phase 1 Dose Escalation Trial" was published in current issue
of The Lancet Oncology (February 2012). The study combined fixed doses
of GVAX Prostate in combination with escalating 0.1, 0.3, 1.0, 3.0 and
5.0 mg/kg doses of Ipi. The study enrolled 12 patients in three dose
escalation cohorts and 16 patients in an expansion Ipi 3.0 mg/kg
cohort.
The reported duration of disease stabilization ranged from 3-27 months,
and the median duration of PSA response was 12 months, (range 2-21
months). There were no serious adverse events in the lower dose Ipi
cohorts and administration of immunotherapy was well tolerated and
safe.
The investigators concluded that, "Further research on the combined
treatment of patients with mCRPC with vaccination and Ipilimumab is
warranted."

The 28 patient Phase I study was conducted by researchers at the VU
University Medical Centre in Amsterdam, Netherlands. BioSante's
Prostate
cancer vaccine is made from allogeneic prostate cancer cells
genetically
altered to produce an immune system stimulator called GM-CSF, and
irradiated to prevent cell growth. A Phase II GVAX Prostate clinical
trial is anticipated to begin in 2012 at the Johns Hopkins Sidney
Kimmel
Comprehensive Cancer Center.

"We are very excited by the positive results of this prostate cancer
study notably combined with recently reported excellent results in
pancreatic cancer. This is encouraging news concerning the potential
for
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 & chief executive officer.

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(R) (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 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 USA, Inc., and the Pill-Plus(TM), an oral
contraceptive in Phase II clinical development by Pantarhei Bioscience
B.V. BioSante's first FDA-approved product is Elestrin(TM) (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 the timing
of a Phase II GVAX Prostate clinical trial and the potential for GVAX
cancer vaccines, and other statements identified by words such as
"anticipates," "will," "continue," "could," "believe," "intends,"
"expects," "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, uncertainties
regarding clinical testing, the difficulty of developing pharmaceutical
products, obtaining regulatory and other approvals and achieving market
acceptance; the marketing and other 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 BioSante's 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.

SOURCE: BioSante Pharmaceuticals, Inc.
For Investors:
The Trout Group LLC
Tricia Swanson, [phone]
[e-mail]
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary, 312-506-5220
[e-mail]
Copyright Business Wire 2012
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