Full Press Release Details
TITAN PHARMACEUTICALS RECEIVES FDA CLEARANCE
CLINICAL STUDY OF PARKINSON'S DISEASE TREATMENT
First trial site qualified to start
screening study patients
SOUTH SAN FRANCISCO, CA - Aug. 24, 2017 -
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."
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.
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
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.
Titan Pharmaceuticals, Inc.:
Sunil Bhonsle, President