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 Betreff des Beitrags: Phase 3 Studie mit Pagoclone
BeitragVerfasst: Sa Sep 30, 2006 6:09 pm 
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Phase 3 Studie für 2007 geplant

Indevus Pharmaceuticals, Inc. hat weitere klinische Studien für Pagoclone zur Behandlung des Stotterns mit der Zielsetzung einer Zulassung durch die FDA bekanntgegeben. Dazu ist für das erste Halbjahr 2007 der Start einer Phase 3 Studie für Erwachsene geplant.

Parallel hierzu soll eine kleine pharmakokinetische Studie mit stotternden Kindern durchgeführt werden.
Die Pharmakokinetik beschreibt, wie rasch und in welchem Ausmaß nach der Verabreichung eines Stoffes dieser anschließend im Blutplasma und in den verschiedenen Körpergeweben auftritt und wo und in welcher Weise er wieder ausgeschieden wird. Aus diesen Resultaten werden die Dosen ermittelt um im weiteren Verlauf des Jahres pädiatrische Phase 2 und 3 Studien einzuleiten.

Indevus hat zu den Resultaten der Phase 2 Studie bislang noch keine umfassenden Angaben zur Effektstärke veröffentlicht.
Es wird aber berichtet, dass einige Probanden eine fast normale Sprechflüssigkeit erfahren haben.

Holger Stenzel



Indevus Announces Clinical and
Regulatory Plans for Pagoclone

Company to Move Forward in Phase III Trials in Stuttering

LEXINGTON, Mass. (Sept. 26, 2007) - Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced that following an End of Phase II meeting with the FDA, the Company has established a clinical plan towards regulatory approval of pagoclone for the treatment of persistent developmental stuttering (PDS) and will initiate a Phase III trial in the first half of 2007.



“The Company met with the FDA to discuss the results of our Phase II trial in adults with PDS and to explore ideas for the design and conduct of future trials,” said Glenn L. Cooper, M.D., president, chief executive officer and chairman of Indevus. “Although the FDA had never considered a drug for stuttering, FDA officials were, in my opinion, extremely well-prepared and were able to give us specific and useful guidance that has allowed us to map out a clear path toward an NDA submission. Specifically, the FDA advised the Company to: 1) pursue pediatric studies in parallel with adult studies so that if pagoclone is effective and safe in both populations, the NDA could be approvable for the broadest possible stuttering population; 2) conduct the next adult and pediatric placebo-controlled trials as fixed dose-response studies to determine the minimally-effective dose; 3) pursue Phase III trials under special protocol assessments (SPAs) to allow the FDA to formally sign off on trial designs. Importantly, the FDA tentatively agreed, pending the SPA review process, to the Company’s proposal on primary and secondary study endpoints and study duration.”



“We are pleased to follow the guidance of the FDA and are excited to pursue pagoclone for pediatric indications sooner rather than later,” continued Dr. Cooper. “There is a tremendous medical need to improve the lives of children and adolescents who stutter, as well as adults who have persistent stuttering. We are making plans to initiate a Phase III trial in adults in the first half of calendar 2007, and to conduct a small pharmacokinetic study in children to enable us to choose doses for a Phase II / III pediatric study to start later in 2007.”



Results from the Phase II clinical trial in adults were announced on May 24,2006 (see press release below). The trial was an 8-week, placebo-controlled, double-blind, multi-center trial with an open label extension. A total of 132 patients were randomized. Results from the trial showed that pagoclone produced a statistically significant benefit in multiple primary and secondary endpoints compared to placebo. Additionally, pagoclone produced either numerically superior improvement or trends for significant improvement on virtually all other primary and secondary endpoints when compared to placebo. Pagoclone was shown to be well tolerated and not associated with any serious adverse events.



“In addition to the promising results seen in the double-blind portion of the trial,” said Dr. Cooper, “the Company has been assessing the safety and efficacy of pagoclone as patients continue to receive the compound in the long term, open-label extension phase. It appears that in a significant number of patients, the magnitude of response to pagoclone increases with time, with some patients experiencing near normal fluency.”



About Stuttering

Nearly 3 million Americans, or as much as 1% of the population, are afflicted with persistent stuttering, with approximately 4 times as many males being affected by the condition as females. Stuttering is a DSM-IV-TR Axis I disorder and is characterized by symptoms in which the flow of speech is disrupted by prolongations, repetitions, and blocks of sounds, syllables, words or phrases. The exact cause of stuttering is unknown; however, emerging evidence has shown that this disorder is associated with abnormalities in brain areas related to speech motor control. Stuttering most often begins in early childhood and often persists into adulthood and this form is classified as persistent developmental stuttering. Given the importance of communication in daily life, stuttering can often impair an individual’s academic, social and occupational functioning. No medication is FDA approved for stuttering and the most commonly utilized treatment is speech therapy.



About Pagoclone

Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator. It is part of a new chemical class of agents and lacks many of the common benzodiazepine side effects such as sedation and withdrawal. Pagoclone trials have enrolled over 1,600 patients to date. The precise mechanism of action is unknown, however, GABA is believed to be an important neurotransmitter in the brain that may be disrupted in people who stutter. Pagoclone enhances the activity in GABA circuits in the brain and thus may help restore more normal function in speech areas of the brain. In early 2005, Indevus was granted a U.S. patent directed towards the use of pagoclone for the treatment of stuttering.



About Indevus

Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products to treat urological, gynecological and men’s health conditions. The Company currently co-promotes SANCTURA® for overactive bladder and markets DELATESTRYL® to treat male hypogonadism and currently has six compounds in clinical development. The compounds in clinical development include SANCTURA XR™, the once-daily formulation of SANCTURA, NEBIDO® for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.

Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA® and SANCTURA XR™; the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA, SANCTURA XR and NEBIDO®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing, marketing, and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; our reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.


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 Betreff des Beitrags: Pagoclone
BeitragVerfasst: Do Okt 05, 2006 4:07 pm 
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Das Medikament überzeugt mich überhaupt nicht. Es gibt schon andere Medikamente die nach dem gleichen Wirkunsprinzip funktionieren. Valium ist zum Beispiel eins.

grüsse


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BeitragVerfasst: Do Okt 05, 2006 6:07 pm 
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Dass Valium bei 50% der Probanten das Stottern signifikant beeinflusst, ist mir neu. Sicher hast Du da genauere Informationen?

Offenbar hast Du Pagoclone schon probiert, da es Dich nicht überzeugt. Warum schreibst Du dann keinen Erfahrungsbericht?

Gruß Suche


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BeitragVerfasst: Mo Okt 30, 2006 6:19 am 
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Experience of Pagoclone

The drug hasn't completely 'cured' me, but has helped tremendously. What I say to the folks in the clinic is -- am I supposed to sound like the folks on tv? So nice and so polished? Sometimes I do. Sometimes after a caffeine high, I just rip through my speech like an auctioneer.

I'm also getting a little more bold. I talk to people in public who I wouldn't have a year ago. At the pizza place, I now ask to change marinara sauce to garlic. Also, I never suffered from anxiety. I'm very laid-back. I have a rough time saying my name and introducing myself. But it's gotten a little better. I still drag out my first syllable, but it's not as long as it used to be. And I'm able to jump right into whatever I need to say so the listener doesn't think twice about it. Honestly, I feel that maybe the drug is relaxing me a bit more. That it's sort of forcing me to slow down my verbal output. It's strange. And as you said about the placebo effect, it's uncertain about what else is happening after I start speaking more fluently -- confidence builds, words are easier, I start smiling more, etc.

I've had absolutely no side effects from this as all. Then again, this is all just me. Your mileage will, of course, vary. I think once the next phase of this trial is over, I might get off the drug for a bit just to see what happens. I'm curious about the confidence effect. And the fact that I'm maybe thinking about slowing things down a lot more to make it easier. I'm also talking to my son more -- and not stuttering. He might have an effect.


Quelle: The Stuttering Brain


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BeitragVerfasst: So Nov 26, 2006 4:43 pm 
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Hoffnung: Eine Pille gegen das Stottern


Dr. Gerald Maguire, Psychologieprofessor an der University of California in Irvine, hat sich dem Kampf gegen das Stottern verschrieben - weil er selbst darunter gelitten hat. Er weiß deshalb auch aus Erfahrung, wie schwierig es ist, dieses Leiden durch spracherzieherische Mittel, die äußerste Disziplin erfordern, zu bekämpfen. „Eine Pille muss her, ein Medikament", wurde seine Devise. Sie basiert auf einem Umdenken, das in medizinischen Kreisen inzwischen weitestgehend akzeptiert wird: Stottern ist weniger eine nervös-emotionale, als eine neurologische Erscheinung, die auch genetische Wurzeln haben kann - also vererbt worden sein kann.

Unter der Leitung von Dr. Maguire ist kürzlich die bisher größte und zeitlich längste Testreihe mit einem Medikament gegen das Stottern abgeschlossen worden - er war selbst unter den „Versuchskaninchen". Sieben Jahre lang nahm er die von Eli Lilly entwickelte Pille Zyprexa, und jetzt - noch bevor dazu eine wissenschaftliche Studie veröffentlicht wird - erklärte er, seine Sprache sei durch Einnahme des Mittels „beträchtlich verbessert, viel fließender" geworden. Schon acht Wochen nach Beginn einer Testreihe mit Stotterern hatten 55 Prozent von ihnen bedeutende sprachliche Fortschritte gemacht.

Fast jedes Medikament hat Nebenwirkungen, so auch Zyprexa. Es wird mit Diabetes und Gewichtszunahme in Zusammenhang gebracht. Dr. Maguire nahm in den sieben Jahren, die er das Mittel zu sich genommen hat, etwa neun Kilogramm zu. „Aber wer aufs Mittelalter zu geht", kommentiert er das scherzend, „nimmt sowieso zu - also hätte ich einen Teil dieser neun Kilo auch angesetzt".

Dr. Maguire hat auch mit anderen Pillen experimentiert, die Stottern beseitigen sollen: Risperdale etwa aus dem Hause Johnson and Johnson oder - die neueste Entwicklung - Pagoclone von Indevus Pharmaceuticals, früher bekannt unter dem Namen Interneuron. Er ist von Pagoclone besonders angetan: „Einige Patienten haben dank der Einnahme des Mittels Arbeitsplätze, die sie sich ersehnt hatten, gefunden und andere wagten sich wieder mehr in die Öffentlichkeit - sie fanden sogar Partner. Es ist, als ob betroffene Menschen ihr Schneckenhaus verlassen". Testperson Claire Byrne: „Mir ist zweifellos geholfen worden". Eine andere Frau, die an der Pagoclone-Reihe teilnahm: „Ich fühle mich befreiter und spreche jetzt viel lieber".

Zu den weltweit prominentesten Stotterern zählten der britische Kriegspremier Churchill und die Schauspielerin Marilyn Monroe. Auch Moses soll gestottert haben. Er schickte deshalb, so die Sage, mitunter seinen Bruder Aron vor, der dann verkündete, was er - Moses - selbst nur schwer verständlich von sich gegeben hätte.

Trotz aller Fortschritte bleibt Stottern ein Problem, sind die genauen Ursachen noch nicht restlos bekannt. In der Regel ist das Sprachzentrum in der linken Hälfte des menschlichen Hirns angesiedelt, bei Stotterern dagegen findet sich ein großer Teil dieser Aktivität in der rechten Hälfte. Es stottern weltweit viermal mehr Männer als Frauen. Einer Schätzung zufolge stottert ein Prozent der Weltbevölkerung. Etwa 50 Prozent der Stotterer können ihr Leiden auf Vererbung zurückführen. Das hat der Genetiker Dennis Drayna ermittelt. Er hat beispielsweise eine prominente Familie von Kamerun genau unter die Lupe genommen. Von 106 Erwachsenen dieser Familie waren 48 Stotterer. DNA-Studien ergaben in diesem Zusammenhang, dass Regionen der Chromosome Eins und Zwölf „Stotter-Gene" beherbergen.

Quelle: gesundheit.com/Wolfgang Will


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 Betreff des Beitrags: Spende für die Forschung
BeitragVerfasst: Mi Jan 03, 2007 10:07 pm 
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Das Forscherteam um Gerry Maguire an der University of California, Irvine in Orange kann sich über eine Spende von 1 Mio Dollar freuen.

Der Sponsor Grandville Kirkup hatte bereits die Multicenterstudie mit Olanzapine finanziell unterstützt.


Wednesday, December 20, 2006
UCI receives $1 million for speech research
Gift from Newport man with disorder will support endowed professorship.
By GARY ROBBINS
The Orange County Register
A Newport Beach man who suffers from a speech disorder has donated $1 million to UC Irvine to support the work of a researcher who does pioneering research in stuttering, the campus says.

Granville Kirkup, who founded the telecom company Telmar Logistics, donated the money to UCI's Department of Psychiatry and Human Behavior. It will endow a professorship to be held by researcher Gerald A. Maguire, who also has experienced periods of stuttering.

Maguire has been using old and new drugs to attempt to control stuttering, an affliction that affects about 3 million Americans, or 1 percent of the population.

UCI says in a release that Maguire has treated Kirkup, which allowed him to "go on and build and later sell Telmar Logistics, a multimillion-dollar distributor of telecommunications products."

Irvine has more than 60 endowed chairs, or professorships that use interest income from the gift to support the chief researcher and staff.

Contact the writer: Register science editor Gary Robbins can be reached at 714-796-7970 or grobbins@ocregister.com. Read his daily science blog at blogs.ocregister.com/sciencedude.


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BeitragVerfasst: Di Mär 06, 2007 2:21 pm 
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Die Phase 3 Studie mit Pagoclone beginnt vorraussichtlich im Juni diesen Jahres in den USA.

Zur Zeit wird an der University of California, Irvine ein von dem kalifornischen Unternehmer Granville Kirkup gestifteter Lehrstuhl eingerichtet (Kirkup Endowed Chair for Stuttering Treatment and Research).

Im weiteren öffnet in Orange, CA das erste Center für die medizinische Behandlung des Stotterns, wo, wie verlautbart wurde, sich Betroffene aus aller Welt nach dem letzten Stand der Forschung pharmakologisch behandeln lassen können.

Es wäre interessant zu recherchieren inwiefern hier eine Kostenübernahme durch deutsche Krankenkassen möglich wäre?


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BeitragVerfasst: So Mär 25, 2007 12:22 pm 
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Jetzt scheint eine erste Fachpublikation zur Pagoclone Studie submittiert zu sein:

Maguire, G., Franklin, D., Vatakis, N., Morgenshtern, E., Denko, T., Yaruss, S., Spotts, C., Davis, L., Davis, A., Fox, P., Ingham, R., Poonam, S., Blomgren, M., Silverman, A., Riley, G. (submitted).

"Exploratory randomized clinical study of Pagoclone in persistent developmental stuttering: The EXPRESS Trial."


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BeitragVerfasst: Mi Apr 18, 2007 7:20 pm 
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In einem aktuellen Quartalsreport schätzt Indevus Pharmaceuticals Inc. die weiteren Entwicklungskosten für
Pagoclone for Stuttering auf etwa 60 Mio. US-Dollar.

Siehe auch dazu den Kommentar von Tom Weidig auf The Stuttering Brain.

http://thestutteringbrain.blogspot.com/


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BeitragVerfasst: Di Mai 01, 2007 2:02 pm 
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Hier ein Auszug aus einem CNN Beitrag:


GUPTA (voice-over): For Ken Steinhardt, making a simple phone call can be nerve-racking.

KEN STEINHARDT, STUTTERER: Would you tell her that Ken S -- Ken, Ken, ah, Ken Steinhardt called?

GUPTA: Ken has stuttered since he was a little boy. For years, he tried to hide it.

STEINHARDT: I wouldn't talk unless I absolutely had to.

GUPTA: Some 3 million Americans stutter. Most people start stuttering when they first learn to speak. And boys tend to stutter more than girls. For years, the conventional treatment has been speech therapy. Often, children come up with creative ways to cope. GERALD MAGUIRE, DR., UNIV. OF CALIFORNIA, IRVINE: I remember in kindergarten, first, second grade, I would imitate cartoon voices in class when I would be called upon. Hello, my name is Donald Duck or whatever. I haven't done them for a while, but...

GUPTA: Jerry Maguire grew up to be Dr. Maguire.

MAGUIRE: I likely stuttered the rest of my life.

GUPTA: A psychiatrist and researcher at UC Irvine, Dr. Maguire is one of the world's leading experts on stuttering. He's one of a growing number who believes stuttering is not caused by a psychological weakness, but by an anatomical problem in the brain.

MAGUIRE: We're learning that stuttering is actually a miscommunication of the brain speech centers with the mouth, throat, and tongue in getting the words out.

GUPTA: To better understand, let's take a tour through the brain. First off, this is the basil ganglea (ph), which controls speech. In people who stutter, it is believed the striatum is bombarded with too much dopamine.

Maguire and other researchers believe this anti-anxiety medication called pagaclone, can control stuttering by controlling dopamine, with no side effects.

MAGUIRE: We found that the medication was effective in reducing stuttering in over half, in over half the patients.

GUPTA: Pagaclone doesn't cure stuttering, but it does curb it.

MAGUIRE: I believe that the future of stuttering treatment will combine therapy and medications both.

GUPTA: Ken Steinhardt has been participating in the clinical trial for over a year.

STEINHARDT: Move, move...

GUPTA: And while Ken still stutters, pagaclone has helped dramatically.

STEINHARDT: Well, now, I have a free flow of thought that I've never experienced before. It's kind of weird. It's like a, kind of a revelation.

GUPTA: A revelation that doctors hope other people who stutter will soon experience.

(END VIDEOTAPE)


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BeitragVerfasst: So Mai 06, 2007 9:32 pm 
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New drugs for stuttering may be on the horizon

Gerald A. Maguire, M.D. University of California,Irvine School of Medicine

A medication for stuttering? This question has plagued clinicians for years with the general
consensus that it could never be attained. With advancements in neuropharmacology, medical science is now closer than ever in the development of medication treatment for stuttering.

In the last ten years, studies suggest that dopamine-blocking medications are effective in reducing
stuttering symptoms.

These studies employed the gold-standard of being placebo controlled and double-blind (meaning that the subjects and clinicians did not know if the specific individuals were receiving a real pill or a fake pill).

These studies were of relatively limited subject size so further research is warranted before these medications are to be routinely used in stuttering.

No one medication is without the potential of side-effects and this class of medication is associated with weight gain and the potential for blood sugar increases.

However, a novel edication, pagoclone, holds promise as an effective, well-tolerated medication for the treatment of stuttering. Pagoclone is a medication under development from Indevus Pharmaceuticals.

In May 2006, Indevus released results of the largest pharmacologic trial of stuttering ever completed Pagoclone affects a natural neurochemical in the brain known as GABA which has been postulated to play a significant role in stuttering. The study utilized a doubleblind, randomized design of over 130 adult individuals who stutter. Pagoclone was found to improve stuttering symptoms in over 50 percent of the individuals treated—statistically greater than those receiving a placebo. Pagoclone was found to be well-tolerated with only minor side-effects of eadache and fatigue reported in a minority of those treated. In this study, pagoclone not only improved the fluency of speech but also reduced the social anxiety that often accompanies
stuttering.

More studies of this compound are being planned, and Indevus is working closely with the Food and Drug Administration (FDA) to achieve approval so that this medication may one day be routinely available from a physician’s prescription. For the time being, it is only available as part of a research study. The next study of pagoclone will begin this summer, and one can earn more by accessing www.stutteringstudy.com.

In addition, the University of California, Irvine, has received a generous gift from the philanthropists, Granville and Sidney Kirkup, which will support further research on the medical treatment of stuttering. The University of California, Irvine will participate as a site in the pagoclone study, but will also be investigating other medications for the treatment of stuttering as well. For further information, please e-mail gerald.maguire@uci.edu.

Even though medications for stuttering may be on the horizon, no form of therapy for stuttering
is a cure. Therefore, future treatment will likely involve the combination of medication
with speech therapy to achieve the optimal results.


Quelle: Stuttering Foundation of America, Newsletter Summer 2007


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BeitragVerfasst: Mi Jun 13, 2007 6:04 pm 
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News Release
Indevus Announces Presentation of Pagoclone Data at 47th Annual New Clinical Drug Evaluation Unit Meeting
Open-label Extension of Phase II Study Demonstrates Significant Additional
Improvement for Patients on Pagoclone
LEXINGTON, Mass., June 12 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that results from the Company's Phase II EXPRESS trial for pagoclone in persistent developmental stuttering will be presented today at the 47th annual meeting of the New Clinical Drug Evaluation Unit (NCDEU), sponsored by National Institute for Mental Health (NIMH) and being held in Boca Raton, Florida. In addition, the presentation will include data from the first three months of open label treatment.

"The progress of the ongoing Phase II open-label phase has been extremely encouraging," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "Our investigators are reporting significant benefit for the vast majority of patients continuing in the open label phase and for several patients, these benefits have been life-changing."

"The results from the open-label extension study reveal that pagoclone is a promising medication for the long-term treatment of stuttering," stated Gerald A. Maguire, M.D., associate professor, department of psychiatry, University of California, Irvine School of Medicine. "As a researcher and a person who stutters, I am excited about the results. Although there is no cure for stuttering, this study suggests that pagoclone holds significant promise as a well-tolerated, effective pharmacologic treatment for stuttering and further studies are indicated."

The open label data demonstrated an improvement in nearly all efficacy measures compared to baseline that was at least double the magnitude seen in the initial 8 weeks of double-blind treatment. During the 8-week, double-blind portion of the study, patients who were randomized to placebo experienced a mean reduction in the percentage of syllables stuttered of 5%. After three months in the open label portion of the study, these same patients experienced a 31% mean reduction. These open label gains lagged slightly the gains made by patients originally randomized to 8 weeks of active pagoclone (5 months total exposure). For those patients randomized to pagoclone in the double- blind phase, the mean reduction in percent syllables stuttered was 18%, while in the open label phase, the mean reduction was 40%.

Similarly, data for the Clinician's Global Impression of Improvement (CGI- I) showed considerable gains during the three months of open label treatment. For patients receiving placebo during the double blind phase, 36% were rated as improved, while following three months of open label treatment, 80% were rated as improved. For patients receiving active pagoclone during the double blind phase, 55% had been rated as improved, and following three additional months of open label treatment with pagoclone, 90% were rated as improved. These results indicate that, while the beneficial effects of pagoclone were evident within the 8-week double-blind phase, the magnitude of benefit continued to grow for at least three months. Pagoclone has continued to demonstrate a very favorable safety profile during the open label phase. These results have been submitted for publication to a leading journal in this field.

Additionally, approximately half the patients who participated in the double-blind phase had a high level of social anxiety symptoms pre-treatment, as measured using the Liebowitz Social Anxiety Scale (LSAS). In this high- severity subgroup, pagoclone demonstrated statistically significant improvements in the LSAS Total scale compared with placebo. Both groups, those receiving active pagoclone as well as those receiving placebo, demonstrated continued improvement, achieving over a 20 point mean decrease over the five month period.

Study Design

The Phase II study, known as the EXPRESS trial, was an 8-week, placebo controlled, double-blind, multi-center trial with an open label extension. There were a total of 132 patients randomized in the trial. Eighty-eight patients received escalating doses of pagoclone from 0.3 mg to 0.6 mg per day. Forty-four patients received placebo. Seventy-nine percent of the patient population was male, which is reflective of the gender distribution of this disorder. Although open label treatment is not blinded, patients and investigators remained blinded to the original treatment allocation during the 8-week double-blind phase.

More than 70% of the 119 patients who entered the open label phase of the EXPRESS trial were included in the three month open label data being presented at NCDEU.

Study Results

The primary endpoints evaluated in the double-blind, phase of the study were the Frequency and Duration Subscale of the Stuttering Severity Instrument Version 3 (SSI-3), the Stuttering Severity Scale (SEV) and the Subjective Screening of Stuttering (SSS) Severity Subscore. Given that this was an exploratory study, pre-specified analyses utilized 1-tailed tests of significance.

The SSI-3 is a validated measure of stuttering. During study visits at week 4 and week 8, patients were videotaped while engaged in both a conversational and reading task. The videotapes were analyzed and scored at a central laboratory. Raters were blinded with regard to treatment and visit. The frequency and duration subscales were calculated by measuring the proportion of syllables stuttered compared to syllables spoken and the length of time of each stuttering block or event. The variability of stuttering naturally tends to wax and wane over time. Accordingly, two data points were collected prior to treatment and two data points were collected while on treatment at week 4 and week 8 to determine the on-treatment effect of pagoclone. The on-treatment effect of pagoclone was shown to produce a statistically significant reduction in the frequency and duration of stuttering as measured by the SSI-3 scale when compared to placebo (p=.02). While receiving 8 weeks of placebo, patients had experienced a mean reduction of approximately 5% in the percentage of syllables stuttered, however after three months of open label treatment, patients achieved a reduction of 31%. These open label gains lagged slightly the gains made by patients originally randomized to 8 weeks of active pagoclone (5 months total exposure), who had, during the double blind phase, experienced a mean reduction of 18% of syllables stuttered and then went on to achieve a reduction of 40% of syllables stuttered after three months of the open label extension.

The SEV, measured at week 2, week 4 and week 8, is a validated measure of stuttering. The SEV is a 9-point, clinician rated severity scale anchored by "no stuttering" and "extremely severe stuttering." The on-treatment effect of patients receiving pagoclone demonstrated a numerically superior rating versus patients treated with placebo (p=.18).

The SSS Severity Subscore, measured at week 2, week 4 and week 8, is a validated, patient-rated assessment of stuttering that takes into account specific speaking situations that have taken place over the prior week. Pagoclone produced a statistically significant reduction at week 2 (p=.004) and week 4 (p=.05) and a trend for significant improvement at week 8 (p=.08) as compared to placebo.

The secondary endpoints evaluated in the study included the Clinician Global Impression-Improvement (CGI-I), the Liebowitz Social Anxiety Scale (LSAS) and the Speech Naturalness Scale (SNS).

The CGI-I, measured at week 2, week 4 and week 8, is a 7-point, validated and widely accepted clinician-rated measure of improvement as compared to baseline, considering all sources of available clinical information about the patient. For analysis of the improvement in the severity of stuttering, patients were categorized as having either "improved" versus "no change or worsened." Pagoclone produced numerically superior improvement at week 2 (p=.20) and statistically significant improvement at week 4 (p=.007) and at week 8 (p=.02) as compared to placebo. At week 8, 55% of pagoclone treated patients were improved compared to 36% of placebo treated patients. Open label data showed considerable gains after three months of open label treatment. For patients receiving placebo during the double blind phase, 36% were rated as improved, but following 3 months of open label treatment, 80% were rated as improved. For patients receiving active pagoclone during the double blind phase, 55% had been rated as improved, and following 3 additional months of open label treatment, 90% were rated as improved. These results indicate that, while the beneficial effects of pagoclone were evident within the 8-week double-blind phase, the magnitude of benefit continued to grow for at least three months.

The LSAS, measured at week 4 and week 8, is a validated measure of social anxiety symptoms. Stuttering is often co-morbid with symptoms of social anxiety which can be a disabling consequence of stuttering. Although patients with primary anxiety disorders were excluded from participating in the trial, pagoclone produced a trend for significant improvement in social anxiety symptoms (total LSAS score) compared to placebo at week 4 (p=.09) and week 8 (p=.07). On a subscale comprised of the elements of the LSAS that evaluate anxiety-provoking speaking situations, pagoclone produced statistically significant improvement at both week 4 (p=.02) and week 8 (p=.02). Approximately half the patients who participated in the double-blind phase had a high level of social anxiety symptoms pre-treatment, as measured using the LSAS. Patients treated with pagoclone demonstrated statistically significant improvements in the LSAS Total scale compared with placebo. During the open label extension, both groups, those receiving active pagoclone as well as those receiving placebo, demonstrated continued improvement, achieving approximately a 20 point mean decrease over the five month period.

Pagoclone was shown to be safe and well-tolerated. There were no serious adverse events associated with pagoclone. The most commonly reported side effects associated with pagoclone were headache (12.5% for pagoclone and 6.8% for placebo) and fatigue (8% for pagoclone and 0% for placebo). As with all prior trials for pagoclone, reports of somnolence and sedation were similar between pagoclone and placebo. Additionally, pagoclone exerted its clinical effect on patients without disrupting the naturalness of their speech as assessed by the SNS, a validated 9-point scale.

Pagoclone has continued to demonstrate a very favorable safety profile during the open label phase.

About Stuttering

Nearly 3 million Americans, or as much as 1% of the population, are afflicted with persistent stuttering, with approximately 4 times as many males being affected by the condition as females. Stuttering is a DSM-IV-TR Axis I disorder and is characterized by symptoms in which the flow of speech is disrupted by prolongations, repetitions, and blocks of sounds, syllables, words or phrases. The exact cause of stuttering is unknown; however, emerging evidence has shown that this disorder is associated with abnormalities in brain areas related to speech motor control. Stuttering most often begins in early childhood. It often persists into adulthood and this form is classified as persistent developmental stuttering. Given the importance of communication in daily life, stuttering impairs an individual's academic, social and occupational functioning. No medication is FDA approved for stuttering and the most commonly utilized treatment is speech therapy.

About pagoclone

Pagoclone is a novel, non-benzodiazepine, GABA-A selective receptor modulator. It is part of a new chemical class of agents and lacks many of the common benzodiazepine side effects such as sedation and withdrawal. The precise mechanism of action is unknown, however, GABA is believed to be an important neurotransmitter in the brain that may be disrupted in people who stutter. Pagoclone enhances the activity in GABA circuits in the brain and thus may help restore more normal function in speech areas of the brain.

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA(R) for overactive bladder, VANTAS(R) for advanced prostate cancer, and DELATESTRYL(R) to treat male hypogonadism, all of which are currently marketed, as well as SUPPRELIN(R) LA, which was recently approved for central precocious puberty. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include SANCTURA XR(TM), the once-daily formulation of SANCTURA, VALSTAR(R) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and pagoclone for stuttering.

Forward-Looking Statements

Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA(R), SANCTURA XR(TM), NEBIDO(R) and VANTAS(R); the early state of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, VALSTAR(R) and SUPPRELIN(R)-LA; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR and the manufacture of NEBIDO, VANTAS and VALSTAR; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; changes in reimbursement policies and/or rates for SANCTURA, VANTAS, DELATESTRYL and any future products; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; the risk that the businesses of Indevus and Valera Pharmaceuticals, Inc. will not be integrated successfully during the period following the related merger; the risk that the cost savings and any other synergies from the merger may not be fully realized or may take longer to realize than expected; market acceptance for the merger and approved products; risks of regulatory review and clinical trials; disruption from the transaction making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; general worldwide economic conditions and related uncertainties; the effect of changes in governmental regulations and other risks. Indevus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Contact:
Michael W. Rogers Brooke D. Wagner
Executive Vice President and CFO VP, Corp. Communications
(781) 861-8444 (781) 402-3410

SOURCE Indevus Pharmaceuticals, Inc.
-0- 06/12/2007
/CONTACT: Michael W. Rogers, Executive Vice President and CFO,
+1-781-861-8444, or Brooke D. Wagner, VP, Corp. Communications,
+1-781-402-3410, both of Indevus Pharmaceuticals/
/Web site: http://www.indevus.com /
(IDEV)

CO: Indevus Pharmaceuticals, Inc.; New Clinical Drug Evaluation Unit;
National Institute for Mental Health
ST: Massachusetts
IN: MTC HEA
SU: TDS TRI

AM-JK
-- NETU058 --
2435 06/12/2007 07:50 EDT http://www.prnewswire.com


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BeitragVerfasst: Di Jun 19, 2007 7:44 pm 
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Bei Tom Weidigs Blog "The Stuttering Brain" gibt es zur Zeit viele interessante Kommentare zu den aktuellen Daten der Pagoclone Studie.

Im weiteren berichtet ein promovierter Physiker von seinen verblüffenden Erfahrungen mit dem Medikament Ativan ( Wirkstoff Lorazepam).

http://thestutteringbrain.blogspot.com/


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 Betreff des Beitrags: Positive Tendenz
BeitragVerfasst: Fr Aug 03, 2007 7:32 am 
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Stuttering: Drug destined for different disorders decimates defect
02 August 2007
Hats off to drug company Indevus Pharmaceuticals for its persistence in trying to find a health problem for its drug pagoclone.
The drug started life as a therapy for panic disorders, but this approach was abandoned after research found it didn’t help. Then it was pushed forward as a solution to premature ejaculation, but again the company had to admit that the drug was not effective.

Possibly out of sympathy, officials at America’s drug regulator, the Food and Drug Administration (FDA), suggested to distressed Indevus staff that they might like to try out the drug on children and adolescents who stutter.

“We are pleased to follow the guidance of the FDA,” said a relieved Dr Glenn Cooper, the company’s president, chief executive and chairman.

A study labelled by Dr Cooper as “the largest ever trial for stuttering” – which sounds impressive but actually involved 132 stutterers – gave the drug the thumb’s up.

Now it’s the toast of local newspapers throughout the USA. One interviewed former stutterer John Ohman, whose life has been transformed since he started taking pagoclone. “I think the new medicine is going to be an answer to a lot of prayers,” he told reporters.

I think we can all thank the FDA.


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BeitragVerfasst: So Okt 07, 2007 8:37 pm 
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The Center for the Medical Treatment of Stuttering Opens at University of California, Irvine Medical Center
Researchers Study the Neurological Basis of Stuttering and Help Patients Speak Clearly

Irvine, Calif., October 4, 2007 - Orange, Calif., Oct. 4, 2007 – A one-of-a-kind center offering medical treatment and medication therapy for people who stutter will open today at the University of California, Irvine Medical Center. Dr. Gerald A. Maguire, associate professor of clinical psychiatry and a national expert in the treatment of stuttering, will direct The Center for the Medical Treatment of Stuttering and will welcome community supporters and representatives from the National Stuttering Association at the center’s ribbon cutting ceremony in the UC Irvine Neuropsychiatric Center from 6 to 8 p.m.

“We are tremendously proud to announce the opening of this new center,” said Maureen Zehntner, interim chief executive officer of UC Irvine Healthcare. “Patients who come here for treatment will meet experts who understand the complexities of their disorder and who are passionate about patient care.”

The Center for the Medical Treatment of Stuttering is located on the third floor of the UC Irvine Neuropsychiatric Center. It will be the first center in the world dedicated to improving speech fluency primarily using pharmacologic and potential biologic treatments. Biologic treatments or medications that are made up from proteins found naturally in the body are being studied for their effectiveness in the treatment of stuttering. Adolescent and adult patients who visit The Center for the Medical Treatment of Stuttering will receive a unique combination of services grounded in the latest scientific research and medical advancements available anywhere.

Funding for the new center came in large part from private donors, including Newport Beach resident Robert Granville Kirkup, founder of the telecom company, Telmar Logistics. Kirkup’s gift of $1.25 million to UC Irvine’s Department of Psychiatry and Human Behavior funded an endowed professorship held by Maguire and is helping support the center’s mission to further research the neurologic and genetic aspects of stuttering.

“Our stuttering center is unique in the world in that it is based on the medical model of treatment and is staffed with physicians and other medical professionals,” Maguire said. “We will utilize pharmacologic methods that have been shown in well-controlled studies to be effective treatments in stuttering.”

Stuttering, a speech disorder characterized by an inability to sustain fluency of speech, affects nearly 3 million Americans, or 1 percent of the population. It typically runs in families and affects more men than women. Symptoms may include frequent pauses, repetitions, phrases or prolonged syllables. The face or upper-body of a person who stutters might also twitch with the struggles to pronounce words correctly. Signs of stuttering tend to emerge in early childhood when language first develops.

Maguire, who stutters himself, understands the frustration and social anxiety that can result. “Simple tasks like speaking on the telephone can exacerbate stuttering and can contribute to elevated levels of anxiety,” he said. “I personally know that people will go to great lengths to avoid speaking publicly. They will limit interpersonal interactions, which can harm relationships, academic achievement and careers.”

Experts no longer believe that stuttering is the result of nervousness or stress alone. Upon looking at brain images of people who stutter, Maguire confirmed that there is a neurological basis for the disorder. He noticed higher levels of dopamine in the areas of the brain responsible for speech. Since that discovery, he has researched various medications for their ability to control stuttering symptoms. Currently, there is no cure for stuttering but researchers are working towards proving the efficacy and safety of pharmacologic treatments.

Maguire is the chief investigator of a study involving pagoclone, a medication that alters the brain chemical GABA and may directly enhance fluency in individuals who stutter. The clinical trials at UC Irvine Medical Center have already yielded positive results. Participants have seen a dramatic improvement in their ability to sustain clear conversations and are experiencing more freedom at work and in social settings. Researchers are continuing to monitor their progress but Maguire believes pagolcone could become the first FDA-approved medication for stuttering.

“Most people will undergo speech therapy to control their stuttering but it might not be enough, especially if treatment did not begin in childhood,” said Maguire. “What may give people the greatest chance for improvement is a combination of effective medication and speech therapy. Our center will also provide speech therapy to those patients interested in combining this with their medication treatment.”

Maguire contends that more people who stutter should receive a thorough evaluation by a medical professional who is familiar with the disorder. Medications affect each individual differently and certain medications used for other conditions may actually worsen stuttering. Also, a trained physician is needed to monitor for the potential of side-effects.

“What patients and the medical community need to understand is that breakdowns in speech are not the result of emotional instability or anxiety alone. They occur because of physical changes in the brain. Effective treatment for stuttering requires a therapeutic and scientific approach,” said Maguire.

The Center for the Medical Treatment of Stuttering will be a resource for adolescents and adults who are seeking medical consultation. For more information or to make an appointment with a UC Irvine Healthcare provider, call 714-456-5807 or e-mail Maguire directly at gerald.maguire@uci.edu.

About University of California, Irvine Healthcare: UC Irvine Healthcare is a clinical entity comprising UC Irvine Medical Center and University Physicians & Surgeons, a faculty practice organization of more than 400 specialty and primary care physicians. UC Irvine Healthcare is committed to providing the highest quality care to Orange County and surrounding communities through UC Irvine Medical Center, a leading university medical center and Level I trauma center. UC Irvine Medical Center is ranked among the nation’s best hospitals by U.S. News & World Report’s annual listing of “America’s Best Hospitals.” For more about UC Irvine Healthcare, visit www.ucihealth.com


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