FYI--Charlotte Mancuso:
Spheramine is a unique cell therapy product utilizing normal human cells attached to microcarriers that enable long-term survival and function of the cells. The particular cells used, called retinal pigment epithelial cells [eye cells] or RPE cells, produce L-DOPA and directly enhance brain levels of dopamine, a neurotransmitter that is deficient in certain brain regions in Parkinson’s patients, leading to movement disorders. --full story follows, followed by Google search results for same topic.
www.titanpharm.com/press/SpheraminePhaseII.html
Titan Pharmaceuticals, Inc.
FOR IMMEDIATE RELEASE TITAN LAUNCHES RANDOMIZED STUDY OF
SPHERAMINEÒ IN PARKINSON’S DISEASE
South San Francisco, CA – December 19, 2002 – Titan Pharmaceuticals, Inc. (ASE:TTP) today announced that it has initiated a multicenter, randomized, blinded, controlled study of SpheramineÒ in Parkinson’s disease. The newly launched Phase II clinical study will enroll 68 patients with later-stage Parkinson’s disease (Hoehn and Yahr Stages III and IV) to further evaluate the efficacy, safety, and tolerability of Spheramine, a novel cell therapy under development by Titan and Schering AG, Germany (FSE:SCH, NYSE:SHR), Titan’s corporate partner for worldwide development and commercialization of Spheramine. Schering AG, Germany is fully funding the clinical development program of Spheramine.
Spheramine is a unique cell therapy product utilizing normal human cells attached to microcarriers that enable long-term survival and function of the cells. The particular cells used, called retinal pigment epithelial cells or RPE cells, produce L-DOPA and directly enhance brain levels of dopamine, a neurotransmitter that is deficient in certain brain regions in Parkinson’s patients, leading to movement disorders. RPE cells can be grown in large numbers using cell culture manufacturing methods to produce many thousands of doses of Spheramine from a single starting tissue sample. Spheramine is injected into the brain regions lacking dopamine, using a surgical technique called stereotactic injection, which does not require general anesthesia.
Previous preclinical studies have demonstrated the preliminary efficacy and safety of Spheramine, including blinded studies in a primate model of Parkinson’s disease. Imaging studies have confirmed the presence of increased dopamine signals in regions treated with Spheramine.
A pilot clinical study of Spheramine performed by Titan in six patients with late-stage Parkinson’s disease demonstrated substantial improvement in motor function in all six patients at one year post treatment with no significant adverse events. These results were reported at the American Academy of Neurology annual meeting in 2002 and recently updated at the International Congress of Parkinson’s Disease and Movement Disorders in November 2002.
“Results from the initial pilot clinical study of Spheramine continue to look very positive,” stated Ray L. Watts, M.D., Professor and Vice Chairman of the Department of Neurology at Emory University School of Medicine and principal investigator for the newly launched study. “All six patients continue to show very good improvement, with five of six patients demonstrating greater than 30 percent improvement in motor function approximately two years after treatment. The duration and magnitude of clinical improvement suggest significant therapeutic potential for Spheramine. Therefore, we look forward to this larger study to more definitively evaluate the efficacy and safety of Spheramine.”
The new study will evaluate the change in motor function from baseline to one year on study, using the Unified Parkinson’s Disease Rating Scale, a validated efficacy parameter for clinical testing in Parkinson’s disease. Safety analysis will be performed by an independent safety monitoring committee after the first groups of 12 and 32 patients have been treated.
Patients will be randomized to Spheramine treatment or sham surgery, a minor surgical procedure that mimics the duration and setting of Spheramine treatment for study blinding. Patients will be evaluated regularly for safety and efficacy by an evaluating neurologist that is also blinded to the treatment received by the patient.
“This randomized study builds upon the strong results of our pilot clinical study,” said Dr. Louis R. Bucalo, Chairman, President and CEO of Titan. “We are pleased to take this important next step in the Spheramine development program.”
About Titan
Titan Pharmaceuticals, Inc. (ASE: TTP) is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system (CNS) disorders, cancer and other serious and life-threatening diseases. Titan’s numerous products in development utilize novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes partnerships with multinational pharmaceutical companies and government institutions for the development of its products.
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, unexpected 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 if necessary. 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.
# # #
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Searched English pages on www.titanpharm.com for spheramine. Results 1 - 30 of about 69. Search took 0.26 seconds.
Titan Pharmaceuticals, Inc.
A Novel Treatment for Parkinson’s Disease Spheramine® is a proprietary,
cell-based therapeutic product for Parkinson’s disease. ...
www.titanpharm.com/products/spheramine_product.html - 22k - Cached - Similar pages
Spheramine Phase II
... FOR IMMEDIATE RELEASE. TITAN ANNOUNCES POSITIVE LONG-TERM RESULTS OF
PHASE I/II STUDY OF SPHERAMINEÒ IN PARKINSON’S DISEASE. Data ...
www.titanpharm.com/press/Spheramine-PhaseII.html - 32k - Cached - Similar pages
Spheramine Phase II Study launched
... 650-244-4993 212-537-8082 212-537-8025. FOR IMMEDIATE RELEASE. TITAN
LAUNCHES RANDOMIZED STUDY OF SPHERAMINEÒ IN PARKINSON’S DISEASE. ...
www.titanpharm.com/press/SpheraminePhaseII.html - 24k - Cached - Similar pages
Spheramine results after 2 years
... FOR IMMEDIATE RELEASE. TITAN ANNOUNCES SPHERAMINEÒ DEMONSTRATES SUSTAINED
BENEFIT TWO YEARS AFTER TREATMENT IN PILOT CLINICAL STUDY. ...
www.titanpharm.com/press/Spheramine_2_Year.html - 29k - Cached - Similar pages
DRAFT 1: SPHERAMINE UPDATE RELEASE
... 650-244-4990. FOR IMMEDIATE RELEASE. TITAN COMPLETES ENROLLMENT OF FIRST COHORT
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DRAFT 1: SPHERAMINE UPDATE RELEASE
... This increase in revenue is principally related to our corporate partnership with
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DRAFT 1: SPHERAMINE UPDATE RELEASE
... The increase in revenues is primarily due to Titan’s corporate partnership with
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www.titanpharm.com/ press/Titan_Q4_YE_2000_Earnings.html - 24k - Cached - Similar pages
DRAFT 1: SPHERAMINE UPDATE RELEASE
... of iloperidone in Japan, and higher SBIR grant revenues from the National Institutes
of Health in support of the development of Spheramine®, our novel ...
www.titanpharm.com/press/TTP_2001_Q2_Earnings.html - 23k - Cached - Similar pages
DRAFT 1: SPHERAMINE UPDATE RELEASE
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of Health in support of the development of Spheramine®, our novel ...
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DRAFT 1: SPHERAMINE UPDATE RELEASE
... Titan has also entered into a corporate partnership with Schering AG to develop
and commercialize Spheramine®, a novel treatment for Parkinson’s disease. ...
www.titanpharm.com/press/Drug_Delivery.html - 16k - Cached - Similar pages
DRAFT 1: SPHERAMINE UPDATE RELEASE
Titan Pharmaceuticals, Inc. Company: Louis R. Bucalo, MD Chairman, CEO & President
Titan Pharmaceuticals, Inc. Tel: 650-244-4990. FOR IMMEDIATE RELEASE. ...
www.titanpharm.com/press/Private_Placement.html - 13k - Cached - Similar pages
Titan Pharmaceuticals, Inc.
... top, Spheramine. 2 April 2003, Titan announces Spheramine® demonstrates
sustained benefit two years after treatment in pilot clinical study. ...
www.titanpharm.com/press/press_subj.html - 36k - Cached - Similar pages
Schering
... FOR IMMEDIATE RELEASE. TITAN PHARMACEUTICALS ANNOUNCES MILESTONE PAYMENT FROM SCHERING
AG IN DEVELOPMENT PROGRAM FOR SPHERAMINE™. South San Francisco, Calif. ...
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Louis R. Bucalo, MD
... South San Francisco, CA, July 28, 1999—Titan Pharmaceuticals, Inc. (AMEX: TTP)
today announced positive efficacy results with Spheramine™, the Company’s ...
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Louis R. Bucalo, MD Alison Roselli Amy Mumma Amy Mumma Alison ...
... TITAN PHARMACEUTICALS, INC. REPORTS POSITIVE PRELIMINARY RESULTS FOR CLINICAL
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www.titanpharm.com/press/Spheramine_Data.html - 29k - Cached - Similar pages
Louis R. Bucalo, MD
... President & CEO. Titan Pharmaceuticals, Inc. Tel: 650-244-4990. FOR IMMEDIATE RELEASE.
TITAN INITIATES CLINICAL TESTING OF SPHERAMINE™ FOR PARKINSON'S DISEASE. ...
www.titanpharm.com/ press/Spheramine_testing_begins.html - 18k - Cached - Similar pages
Titan Pharmaceuticals, Inc.
... results. 2 April 2003, Titan announces Spheramine® demonstrates sustained
benefit two years after treatment in pilot clinical study. 27 ...
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Titan Pharmaceuticals, Inc.
... Stereotaxic Intrastriatal Implantation of Retinal Pigment Epithelial (RPE) Cells
Attached to Microcarriers (Spheramine): A 12-Month Open-Lable Pilot Study ...
www.titanpharm.com/articles/article/spheramine.html - 23k - Cached - Similar pages
Louis R. Bucalo, MD Alison Roselli Amy Mumma Amy Mumma Alison ...
... SPHERAMINE ® IN THE TREATMENT OF PARKINSON’S DISEASE. ... Spheramine is Titan's
first product utilizing the Company's proprietary CCM ™ technology. ...
www.titanpharm.com/press/Spheramine_Helsinki.html - 53k - Cached - Similar pages
[PDF] SECURITIES AND EXCHANGE COMMISSION FORM 8-K CURRENT REPORT Titan ...
File Format: PDF/Adobe Acrobat - View as HTML
... 2002. The change in revenue and net loss is the result of a milestone
payment received for Spheramine® in the first quarter 2002. ...
www.titanpharm.com/pdf/051503_8-K.pdf - Similar pages
[PDF] SECURITIES AND EXCHANGE COMMISSION FORM 8-K CURRENT REPORT Titan ...
File Format: PDF/Adobe Acrobat - View as HTML
... The difference in revenue is primarily due to additional licensing fees for
iloperidone and SBIR grant revenue for Spheramine received in 2001. ...
www.titanpharm.com/pdf/8-K_March_27_2003.pdf - Similar pages
Quarterly Earnings Press Release
... The increase in revenue was primarily due to a milestone payment Titan received
from Schering AG for Spheramine®, Titan’s product in development for ...
www.titanpharm.com/press/Q1_2002.html - 27k - Cached - Similar pages
Quarterly/Year-End Earnings Press Release
... The difference in revenue is primarily due to additional licensing fees for
iloperidone and SBIR grant revenue for SpheramineÒ received in 2001. ...
www.titanpharm.com/press/2002YearEndRelease.html - 31k - Cached - Similar pages
Titan Pharmaceuticals, Inc.
... into a corporate partnership with Schering AG in February 2000 for the worldwide
development, manufacture and commercialization of Spheramine, Titan’s novel ...
www.titanpharm.com/alliances/schering.html - 17k - Cached - Similar pages
Q2 2003 Financial Results
... The difference in revenue is primarily the result of a milestone payment Titan
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www.titanpharm.com/press/Q2_2003.html - 23k - Cached - Similar pages
Quarterly Earnings Press Release
... The difference in revenue is primarily due to a milestone payment Titan received
from Schering AG for Spheramine® in the first quarter of 2002. ... Spheramine®. ...
www.titanpharm.com/press/Q3_2003b.htm - 43k - Cached - Similar pages
2001 Year End Earnings Press Release
... treatment iloperidone in Japan, and higher SBIR grant revenues from the National
Institutes of Health in support of the development of Spheramine®, Titan’s ...
www.titanpharm.com/press/2001_Year_End_Results.html - 28k - Cached - Similar pages
Titan Pharmaceuticals, Inc.
Spheramine. Parkinson's disease, Phase II, Based upon positive results
of a pilot clinical study, Titan and Schering AG, Titan’s ...
www.titanpharm.com/clinical_studies/ spheramine_study.html - 18k - Cached - Similar pages
[PDF] Data Handout2
File Format: PDF/Adobe Acrobat - View as HTML
... efficacy of unilateral stereotaxic implantation of cultured human retinal pigment
epithelial (RPE) cells attached to microcarriers, Spheramine ® , in patients ...
www.titanpharm.com/pdf/SpheramineHandout2.pdf - Similar pages
Quarterly Earnings Press Release
... these supportive study results, the Company is preparing to initiate a number of
new clinical studies, including randomized clinical testing of SpheramineÒ in ...
www.titanpharm.com/press/Q2-2002.html - 56k - Cached - Similar pages
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Wendy Siegel <[log in to unmask]> wrote:
Anybody ever heard of this before?
Eye cell transplants aid Parkinson's patients
18.04.2002
11.00am
WASHINGTON - Eye cells transplanted into the brains of Parkinson's
patients have markedly improved their symptoms and may provide an
alternative to steadily increasing doses of medication, doctors say.
The eye cells produce dopamine, the important chemical lacking in the
brains of people with Parkinson's, whose disease begins with trembling
or stiffness and progresses to a rigidity that leaves them virtually
paralysed.
Dr Ray Watts, a professor of neurology at Emory University School of
Medicine in Atlanta, today said six patients who got the eye cell
transplants showed a regression of their symptoms.
Full story at:
http://www.nzherald.co.nz/storydisplay.cfm?storyID=1542293&thesection=ne
ws&thesubsection=world&reportid=16
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