Full Press Release Details
Lipocine Announces First Patient
Dosed in Phase 1 Study in Pregnant Women of LPCN 1107,
Potentially the First Oral
Product for the Prevention of Preterm Birth
CITY (September 8, 2014) - Lipocine Inc. (NASDAQ Capital Market: LPCN), a specialty pharmaceutical company, today
announced the first patient was dosed in a Phase 1 study in pregnant women of LPCN 1107, the company's
oral hydroxyprogesterone caproate (HPC) product candidate. The primary objectives of the study will be to determine safety, tolerability
and pharmacokinetics of oral administration of LPCN 1107 in pregnant subjects.
"Based on previous clinical testing,
we believe that LPCN 1107 has the potential to become the first oral product for prevention of preterm birth. HPC is the only drug
approved for prevention of recurrent preterm birth, a leading cause of peri-natal mortality and morbidity worldwide, but it is
currently only available in an inconvenient injectable form that may cause pain at the site of injection and requires several visits
to the physician during the course of treatment," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "We look
forward to presenting top-line results from this study in 2015."
This Phase 1, open-label study will
enroll up to eight healthy, pregnant female subjects of child bearing age with a normal pregnancy of 16 to 18 weeks. In period
one, subjects will receive two doses of 400 mg oral LPCN 1107, administered 12 hours apart. In period two, subjects will receive
two doses of 800 mg oral LPCN 1107, administered 12 hours apart. In period three, subjects will be given 250 mg of HPC via intramuscular
injection. There will be a washout period of at least three days between each period. Blood samples will be taken and used to determine
the pharmacokinetics for each period.
Previously in Phase 1 clinical testing,
LPCN 1107 was well tolerated and achieved meaningful drug levels after oral administration in healthy, non-pregnant women.
LPCN 1107 has the potential to become the first oral HPC product
for the prevention of preterm birth in women with a prior history of at least one preterm birth. Potential benefits of our oral
product candidate relative to current injectable products include the elimination of pain and site reactions associated with weekly
injections, elimination of weekly doctor visits or visits from the nurse, and elimination of interference/disruption of personal,
family or professional activities associated with weekly visits.
Lipocine Inc. is a specialty pharmaceutical company developing
innovative pharmaceutical products for use in men's and women's health using its proprietary drug delivery technologies. Lipocine's
lead product candidate, LPCN 1021, currently in Phase 3 and is targeted to treat symptoms of low testosterone for men in need of
testosterone replacement therapy. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone therapy
product, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the
prevention of recurrent preterm birth.
Forward-Looking Statements
This release contains "forward
looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of
1995 and includes statements that are not historical facts relating to the potential uses and benefits of Lipocine's product candidates
and product development efforts. Investors are cautioned that all such forward-looking statements involve risks and uncertainties,
including, without limitation, the risks related to the receipt of regulatory approvals, the results of clinical trials, patient
acceptance of Lipocine's products, the manufacturing and commercialization of Lipocine's products, and other risks detailed in
Lipocine's filings with the U.S. Securities and Exchange Commission (the "SEC"), including, without limitation, its Form
10-K and other reports on Form 8-K, all of which can be obtained on the Company's website at www.lipocine.com or on the SEC website
at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release,
except as required by law.
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Email: mb@lipocine.com
Phone: (443) 213-0500