SOUTH SAN FRANCISCO,
Calif., Titan
Pharmaceuticals, Inc. (NASDAQ: TTNP) announced today that
the U.S. Food and Drug Administration (FDA) has cleared the Investigational New
Drug (IND) application for its ropinirole implant intended for treatment of the
signs and symptoms of Parkinson's disease. The Phase 1/2 clinical study in
patients will commence shortly.
"New treatments that
offer continuous delivery of medication providing non-pulsatile stimulation of
dopamine receptors in the brain appear to have some advantages over oral
formulations," said Dr. Aaron Ellenbogen of the Michigan
Institute of Neurological Disorders, and the principal investigator at the
first trial site, near Detroit, Michigan. "The ProNeura implants with
ropinirole could potentially offer an important treatment option for continuous
drug delivery that overcomes the fluctuating drug levels associated with oral
administration of ropinirole, and we look forward to conducting this
study."
The ropinirole implant,
developed utilizing Titan's ProNeura™ technology, is designed for the
long-term, continuous delivery of ropinirole HCL for the treatment of signs and
symptoms of Parkinson's disease, including stiffness, tremors, muscle spasms,
and poor muscle control. Ropinirole is a dopamine agonist currently available
in daily or more frequently dosed oral formulations for the treatment of
Parkinson's disease symptoms and restless leg syndrome.
The trial is an
open-label, sequential, dose escalation study that will enroll approximately 20
subjects with idiopathic Parkinson's disease across three or more U.S. research
sites. The primary objectives are to characterize the pharmacokinetic profile
of the ropinirole implants, to evaluate their safety and tolerability, and to
explore potential signals of efficacy using established disease-specific
assessment scales. Patients on a stable dose of L-dopa plus oral ropinirole
will have their oral ropinirole switched to ropinirole implants for three
months of treatment.
"While oral
formulations of ropinirole have greatly benefitted those suffering from
Parkinson's disease, many patients develop serious motor complications and
dyskinesias after several years, due to the peak-trough fluctuations of
medication in the blood," said Kate Beebe, PhD, executive vice
president and chief development officer at Titan. "Our ropinirole implant
is designed to provide continuous, non-fluctuating therapeutic levels of
medication for up to three months, potentially offering patients and clinicians
a more effective treatment option. We thank the FDA for their timely review and
comments on the IND and clinical protocol."
About Titan
Pharmaceuticals
Titan Pharmaceuticals
Inc. (NASDAQ: TTNP), based in South San Francisco, CA, is developing
proprietary therapeutics primarily for the treatment of serious medical
disorders. The company's lead product is Probuphine®, a novel and long-acting
formulation of buprenorphine and the first and only commercialized treatment of
opioid dependence approved by the U.S. Food and Drug Administration to provide
continuous, around-the-clock blood levels of buprenorphine for six months
following a single procedure. Probuphine employs Titan's proprietary drug
delivery system ProNeura™, which is capable of delivering sustained, consistent
levels of medication for three months or longer. Titan has granted commercial
rights in the U.S. and Canada for Probuphine to Braeburn
Pharmaceuticals. The ProNeura technology has the potential to be used in
developing products for treating other chronic conditions such as Parkinson's
disease and hypothyroidism, where maintaining consistent, around-the-clock
blood levels of medication may benefit the patient and improve medical
outcomes. For more information about Titan, please visit www.titanpharm.com.
This press release may
contain "forward-looking statements" within the meaning of Section
27A of the Securities Act of 1933 and Section 21E of the Securities Exchange
Act of 1934. Such statements include, but are not limited to, any statements relating
to our product development programs and any other statements that are not
historical facts. Such statements involve risks and uncertainties that could
negatively affect our business, operating results, financial condition and
stock price. Factors that could cause actual results to differ materially from
management's current expectations include those risks and uncertainties
relating to the commercialization of Probuphine, the regulatory approval
process, the development, testing, production and marketing of our drug
candidates, patent and intellectual property matters and strategic agreements
and relationships. We expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in our expectations or any changes in
events, conditions or circumstances on which any such statement is based,
except as required by law.
CONTACT:
Titan Pharmaceuticals,
Inc.:
Sunil Bhonsle, President
(650) 244-4990
Sunil Bhonsle, President
(650) 244-4990
Investors:
Stephen Kilmer
(650) 989-2215
skilmer@titanpharm.com
Stephen Kilmer
(650) 989-2215
skilmer@titanpharm.com
Media:
Susan Thomas
(650) 989-2216
sthomas@titanpharm.com
Susan Thomas
(650) 989-2216
sthomas@titanpharm.com
SOURCE Titan
Pharmaceuticals, Inc.
Related Links
http://www.prnewswire.com/news-releases/titan-pharmaceuticals-receives-fda-clearance-to-begin-clinical-study-of-parkinsons-disease-treatment-300508916.html
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