Surely hope it is.
TTP news today (very small numbers of the pts in trial with Spheramine, but for the first time some evidence of the medical benefit with dopamine-cell based approach) also deserve to be mentioned here, imo.
If someone disagree, well he/she can complain at SI web-master. <g>
Thursday April 18, 8:13 am Eastern Time
Press Release
SOURCE: Titan Pharmaceuticals, Inc.
Titan Announces Positive Long-term Results of Phase I/II Study of Spheramine in Parkinson's Disease
SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--April 18, 2002-- Titan Pharmaceuticals, Inc. (ASE:TTP)
Data Presented at American Academy of Neurology Demonstrate
Significant Improvement in Motor Function
in Late-Stage Parkinson's Patients
Titan Pharmaceuticals, Inc. (ASE:TTP) today announced that treatment with Spheramine® produced a nearly 50 percent improvement in motor function in patients with advanced Parkinson's disease in a recently completed, 12 month Phase I/II study. Spheramine is a novel cell therapy product for the treatment of Parkinson's disease being developed by Titan in collaboration with Schering AG (FSE:SCH, NYSE: SHR), Titan's corporate partner for the development of Spheramine.
The new data, presented today at the 54th annual meeting of the American Academy of Neurology, also demonstrated significant improvement in quality of life for all patients treated, with no significant adverse events. Based upon the positive results of this study, Titan and Schering are preparing to initiate a randomized clinical study of Spheramine.
``The long-term results from this pilot clinical study with Spheramine are very favorable and confirm the preliminary findings of the study,'' said Ray L. Watts, M.D., professor and vice chairman of the Department of Neurology at Emory University School of Medicine and principal investigator of the study. ``These data indicate that this new approach may hold significant promise for improved treatment of Parkinson's patients.''
Positive Efficacy and Safety Results Seen
The open label Phase I/II study in six patients with advanced PD was designed to evaluate the safety of Spheramine and its efficacy in improving motor function. Patients were evaluated pre- and post-treatment, both `on' and `off' their normal medication, using the Unified Parkinson's Disease Rating Scale (UPDRS), a standard measure of Parkinson's disease severity. The primary efficacy endpoint was the `off' state motor score of the UPDRS at 12 months, which was evaluated pre-treatment and every three months thereafter.
All patients demonstrated significant improvement in motor function, and other outcome measures, with no safety concerns. At 12 months post treatment:
Patients experienced an average 48 percent improvement in motor UPDRS score, off all other medication.
Patients experienced an average 43 percent improvement in total UPDRS score.
Improvements were noted in quality of life and activities of daily living.
Half the patients demonstrated a reduction in pre-existing dyskinesias (involuntary movements) while the remainder had no change from baseline.
No `off' state dyskinesias were observed (patients off PD medication overnight).
All six patients completed the one-year study, with no safety concerns.
Patients will continue to be monitored beyond the one-year study.
``We are very pleased with the success of this pilot study and look forward to advancing the Spheramine development program into randomized, clinical testing in the near future,'' said Dr. Joachim-Friedrich Kapp, head of the Strategic Business Unit Specialized Therapeutics of Schering AG.
Spheramine and Parkinson's Disease
In Parkinson's disease, a neurotransmitter called dopamine is deficient in certain brain regions causing progressive motor symptoms such as tremors, rigidity, and slowed, difficult movements of the arms and legs. Spheramine consists of normal human cells that provide dopamine (RPE cells) attached to microcarriers, and is designed to deliver dopamine to the regions of the brain affected by Parkinson's disease. In this study, Spheramine was delivered unilaterally to the brain. Subsequent studies of Spheramine will utilize bilateral treatment, which may further enhance the therapeutic profile.
``The positive clinical study results demonstrate the potential of Spheramine to contribute significantly to the treatment of Parkinson's patients and we look forward to further clinical testing,'' said Louis R. Bucalo, M.D., chairman, president and CEO of Titan. ``In addition, these data further support the broad potential value of Titan's CCM technology on which Spheramine is based.''
Clinical Results Driven by Broadly Enabling Technology
Spheramine utilizes Titan's novel cell-coated microcarrier (CCM(TM)) technology, which allows normal human cells to survive after surgical injection into the brain. Cell therapy for the treatment of central nervous system (CNS) disorders is normally limited by death of most of the transplanted cells after a few weeks. By maintaining their viability and function, Titan's innovative technology allows the use of normal mature cells, rather than embryonic or stem cells, and eliminates the need for drugs to suppress rejection of the cells. This breakthrough technology potentially allows any cell type to be used in neural transplantation, moving the science of CNS cell therapy beyond stem cells to numerous other cell types.
Numerous scientific studies have demonstrated the efficacy of Titan's CCM technology, which allows normal cells to survive implantation to the brain and provide therapeutic activity. Separately reported, controlled studies in animal models of Parkinson's disease(1-3) and glioma(4), have confirmed the therapeutic potential of this platform technology. Additional controlled, preclinical efficacy studies will be presented at the International Society for Cellular Therapy in May. <snip> |
