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PARKINSN  June 2008, Week 4

PARKINSN June 2008, Week 4

Subject:

Spheramine

From:

rayilynlee <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange Network <[log in to unmask]>

Date:

Tue, 24 Jun 2008 18:49:30 -0700

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (129 lines)

Tuesday, Jun. 24, 2008
Titan Pharmaceuticals Announces Spheramine(R) Presentations at 12th 
International Congress of Parkinson's Disease and Movement Disorders
Five-Year Update of Pilot Study Shows Spheramine Reduces Severity and 
Frequency of Parkinson's Symptoms While Also Improving Health-Related 
Quality of Life
CHICAGO & SOUTH SAN FRANCISCO - Titan Pharmaceuticals, Inc. (AMEX:TTP) today 
announced that Spheramine(R), the company's novel cell-based therapy being 
developed in collaboration with Bayer Schering Pharma AG for the potential 
treatment of moderate to advanced Parkinson's disease, will be featured in 
two scientific posters presented today at the 12th International Congress of 
Parkinson's Disease and Movement Disorders in Chicago.
"We continue to be very encouraged by the positive results from this open 
label pilot study, and of the potential of Spheramine to provide long term 
benefits to patients with moderate to advanced Parkinson's disease," said 
Marc Rubin, M.D., President and CEO of Titan. "We expect to have results of 
our ongoing Phase IIb trial early in the third quarter of this year and look 
forward to important progress with this program which addresses a critical 
unmet medical need for Parkinson's patients."
This open-label pilot study was conducted at Emory University Hospital to 
evaluate the safety, tolerability and preliminary efficacy of Spheramine and 
enrolled six patients with moderate to advanced Parkinson's disease (PD). 
Spheramine was administered in the most affected side of the patient's brain 
using a needle and MRI guidance. The primary exploratory efficacy measure 
was the change in the Unified Parkinson's Disease Rating Scale (UPDRS) motor 
sub-score during the practically defined off-state (patients not taking 
anti-Parkinsonian medications for at least 12 hours), and a preliminary 
evaluation of health related quality of life (HRQoL) using the Parkinson's 
Disease Questionnaire (PDQ-39). Substantial improvements from the baseline 
in UPDRS motor sub-score off medication (44% at year four) and patient 
reported quality of life scores (23% at year four) have been reported during 
the last four years, and the presentations today provide details of patient 
follow-up through year five.
Details of the two presentations are as follows:
"Spheramine(R) Improves Health-Related Quality of Life in Patients with 
Moderate to Advanced Parkinson's Disease" (Abstract 388) will be presented 
by Dr. Natividad P. Stover, Assistant Professor of Neurology at the 
University of Alabama at Birmingham (UAB), on Tuesday, June 24 from 12:30 
p.m. to 2:30 p.m. CDT in the Hilton Chicago's Southeast Exhibit Hall.
The objective of this long-term pilot study was to evaluate health-related 
quality of life (HRQoL) in patients who underwent implantation with 
Spheramine. Six patients were enrolled and were evaluated across a range of 
quality of life factors including mobility, stigma, activities of daily 
living, communication, bodily discomfort, cognition, emotional well-being, 
and social support for five years following Spheramine implantation. 
Overall, HRQoL scores improved for all patients from baseline at five years 
after surgery. Improvement was observed for mobility (41.7%), stigma 
(40.0%), ADL (33.3%), communication (33.3%), bodily discomfort (25.7%), 
cognition (19.0%), and emotional well-being (6.1%), while the measure for 
social support declined (22.2%). These endpoints suggest that unilateral 
implantation of Spheramine may contribute to enhanced HRQoL in moderate to 
advanced PD. This result complements the primary outcomes of safety and 
tolerability in this trial.
"Five-Year Update of the Safety and Efficacy of Unilateral Intrastriatal 
Implantation of Spheramine(R)" (Abstract 598) will be presented by Dr. Ray 
L. Watts, Chair of the University of Alabama at Birmingham (UAB) Department 
of Neurology and Director of Clinical Research, UAB Parkinson's Disease and 
Movement Disorder Research Program, on Tuesday, June 24 from 12:30 p.m. to 
2:30 p.m. CDT in the Hilton Chicago's Northeast Exhibit Hall.
No major new or unexpected safety concerns emerged with the treatment of 
Spheramine during the first five years of the study. Results of the study 
demonstrate that Spheramine reduces the severity and frequency of 
Parkinsonian symptoms in patients who underwent unilateral implantation, and 
these improvements over baseline appear to continue through 60 months as 
observed with a mean improvement of 14% in the UPDRS motor sub-score off 
medication. Although the five-year improvement is modest compared to prior 
years, this is not unexpected with unilateral treatment, since the 
hemisphere not receiving an implant remains untreated. The study has been 
extended to 10 years of evaluation.
Based on the encouraging one-year results in this open-label pilot study, 
Titan and its partner Bayer Schering Pharma AG initiated a multicenter, 
double-blind, randomized, sham surgery-controlled study (STEPS) to further 
evaluate the safety and efficacy of Spheramine. This study completed 
enrollment with 71 patients last year, and top-line efficacy results are 
expected to be available early in the third quarter of 2008.
About Spheramine
Spheramine is a novel cell-based therapy with promise for the treatment of 
moderate to advanced Parkinson's disease (PD). Spheramine consists of human 
retinal pigment epithelial (hRPE) cells attached to a Microcarrier Support 
Matrix (MSM) for enhanced hRPE cell survival. These cells are found in the 
inner layer of the retina and produce levodopa. Spheramine is administered 
in the brain where the levodopa created by hRPE cells is presumably 
converted into dopamine, the neurotransmitter that is decreased in PD due to 
a progressive loss of dopaminergic neurons. Spheramine has been granted Fast 
Track and Orphan Drug status by the FDA.
About Parkinson's Disease
Despite therapeutic advances, there remain substantial limitations to 
currently approved therapies for the treatment of PD and new approaches are 
needed. It is estimated that 60,000 new cases of PD are diagnosed each year, 
adding to the estimated one to 1.5 million Americans who currently have the 
disease. The latest epidemiology studies indicate that worldwide numbers 
will increase from an estimated 4.1 million in 2005 to 8.7 million people 
with PD by 2030.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. (AMEX: TTP) is focused on the late-stage 
development and commercialization of innovative treatments for central 
nervous system disorders including schizophrenia, opioid addiction, 
Parkinson's Disease and chronic pain. Titan has established strategic 
partnerships with leading pharmaceutical companies, including Vanda and 
Bayer Schering, to advance some of these programs. For more information, 
please visit the Company's website at www.titanpharm.com.
The 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 the Company's development program and 
any other statements that are not historical facts. Such statements involve 
risks and uncertainties, including, but not limited to, those risks and 
uncertainties relating to difficulties or delays in development, testing, 
regulatory approval, production and marketing of the Company's drug 
candidates, adverse side effects or inadequate therapeutic efficacy of the 
Company's drug candidates that could slow or prevent product development or 
commercialization, the uncertainty of patent protection for the Company's 
intellectual property or trade secrets, and the Company's ability to obtain 
additional financing. Such statements are based on management's current 
expectations, but actual results may differ materially due to various 
factors, including those risks and uncertainties mentioned or referred to in 
this press release.
Titan Pharmaceuticals, Inc. Investors: Robert Farrell, 650-244-4990 
Executive Vice President & CFO, Titan or Pure Communications Media: Keri P. 
Mattox, 215-790-0105
.
Rayilyn Brown
Director AZNPF
Arizona Chapter National Parkinson Foundation
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December 1999, Week 5
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