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04-28-2008, 11:43 AM | #1 | ||
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Titan Pharmaceuticals Announces Spheramine(R) Presentation at
76th Annual American Association of Neurological Surgeons (AANS) Meeting Results of Open Label Pilot Study Show Long-Term Improvement of Moderate to Advanced Parkinson's Disease; Spheramine Continues to Demonstrate Favorable Safety Profile CHICAGO & SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--April 28, 2008 Titan Pharmaceuticals, Inc. (AMEX:TTP) today announced that four-year follow-up data from an open label pilot study of Spheramine, its novel cell therapy product being developed in collaboration with Bayer Schering Pharma AG for the treatment of moderate to advanced Parkinson's disease, will be presented at the 76th Annual Meeting of the American Association of Neurological Surgeons (AANS) in Chicago. The pilot study was conducted at Emory University Hospital to evaluate the safety, tolerability and preliminary efficacy of Spheramine and included six patients with moderate to advanced Parkinson's disease. Study results will be discussed during a presentation titled "Intrastriatal Implantation of Human Retinal Pigment Epithelial (hRPE) Cells Attached to Gelatin Microcarriers (GM) for the Treatment of Parkinson's Disease (PD)." This presentation is scheduled to be given at the AANS meeting by Roy A. E. Bakay, M.D. on Tuesday, April 29. In this pilot study, Spheramine was administered in the most affected side of the patient's brain using a needle and MRI guidance. The study's primary efficacy measure was the improvement in the motor score of the Unified Parkinson's disease Rating Scale (UPDRS). Secondary efficacy variables included patient-reported quality of life measures. Results of the study show that: -- Long-term improvement of symptoms was demonstrated and, importantly, significant clinical improvements were noted in mobility - an average of 44 percent improvement from baseline at 48 months in UPDRS motor scores. -- Significant clinical improvements were seen in patient-reported quality of life scores - 23 percent improvement from baseline at 48 months -- There were no Spheramine-related serious adverse events reported -- The most frequent adverse event was post-surgical headache, which spontaneously resolved within 1-2 weeks for all patients. Based on the positive one-year results seen in the 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 in third quarter of 2008. The design of this study also will be discussed at the AANS meeting during a separate session. A discussion titled "The STEPS Trial: Design of a Phase 2 Study to Evaluate Spheramine(R), A Novel Cell-Based Therapy Administered by Stereotactic Implantation into the Striata of Patients with Parkinson's Disease (PD)" will be presented by Robert E. Gross, M.D. also on Tuesday, April 29. "We are very encouraged by these continued positive results, and of the promise of Spheramine in treating moderate to advanced Parkinson's patients - a patient population in need of safe and effective treatments that will remain effective over the long-term," said Marc Rubin, M.D., President and CEO of Titan. "We expect to have results of our ongoing Phase IIb trial in the third quarter of this year and look forward to important progress with this program." 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. |
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04-28-2008, 12:52 PM | #2 | |||
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Senior Member
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my fingers are double-crossed!
Peg |
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06-09-2008, 10:22 AM | #3 | ||
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Hi I just joined this little love- fest and boy am glad o be here. I was #4 of the 6 cohort of the saffety trials. I have never met or spoken with any of the others, but I believe one of us has dropped out of the program - Titan is now tracking us 10 years out. Its gettting harder and harder to get to Emory every year , but the surgery was more that worth it.
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06-09-2008, 12:28 PM | #4 | ||
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Senior Member
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I know everyone here would soooo love to hear how you are doing specifically. It is great to read about "average improvement of 44%", but what does that mean exactly? Could you please tell us how you were doing before spheramine, and how your life has changed since the surgery? Any details you could share would be most appreciated! Thanks very much!
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06-09-2008, 06:29 PM | #5 | ||
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As I said, Iam 4of6 in the safety trials. Dr Bakay did the surgery, and I had no adverse effects. I was diagnosed in November of 91, workd ten more years as a financial consultant, and in October of 2000, I retired and began screening at Emory for the safety trials. At this point only Titan was involved- and the surgery was great. Personaly I don't see how anyone could not know if they were given a placebo in the later phases. When I woke up after the implant, I felt 50% better immediatley, and my family said I even looked better
We made monthly pilgrimages the first year- and run through a battery of objectively scored testing. I have been returnig once a year since the second year and will finish at 10 yrs. With the arrival of the funding from the AG Schering volk, the protocol changed completely and became extremely subjective. To me it was not the same study - I only thank Dr Ray Watts for letting me stay" in his face" and ending up allowing me to participate in the safety trials. Spheramine gave me back 10 years and I will never be able to pay them back. |
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06-09-2008, 07:34 PM | #6 | ||
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I am curious as to what you meant by the changes in the study once Schering came on board. Can you describe specifically how you were prior to the surgery, what was most dificult for you? what has been the biggest improvement. Where you adversely affected by your meds (frequent dyskinesia) I could not find a doseage for my sinemet that gave me relief without having dyskinesia. Now that I have had DBS I take the sinemet but don't have them.
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06-10-2008, 07:15 AM | #7 | ||
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Senior Member
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Thanks so much for sharing, it's very encouraging. I also did not understand what you meant when you indicated things changed once Schering came along...how were the evaluations done before they came on board (you mentioned objectively) and how were they done after? I guess I am wondering because the report indicated that the improvement was 44% UPDRS but 23% patient-reported quality of life. I take that to mean that when the patient reported it, they felt it was (again, on average) a 23% improvement over where they were before the surgery, but when someone else did the evaluation/ it rose to 44%. You see where the concern is if this is correct.
Also, when you say you got ten years back, do you mean that you feel like you did ten years ago (and if so, you have one heck of a memory!) or that you feel like the surgery extended your life going forward by ten years. Sorry to be so clueless, maybe everyone else knows exactly what you mean but I am not clear on this. I was also wondering whether you feel that you have progressed at all on the side that received the surgery? And if so, in what way(s), and how long after the surgery did you notice it? It's so wonderful that you are feeling better, I hope you continue to do well. Thank you again for coming forward to share your experience with all of us. |
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06-10-2008, 07:19 AM | #8 | ||
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I believe you have recently met Titan management, can you share any details of interest with us ?
Neil. |
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06-13-2008, 04:06 PM | #9 | |||
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Senior Member
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for the study subjects : do you know the source of the donor tissue? thanks, madelyn
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