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 Betreff des Beitrags: Informationen zur Pagoclone Studie
BeitragVerfasst: So Jul 30, 2006 12:48 pm 
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Informationen zur Pagoclone Studie

Das US-Pharmaunternehmen Indevus Pharmaceuticals, Inc. hat im April 2005 eine Phase 2 Studie mit dem Wirkstoff Pagoclone zur Behandlung des Stotterns initiiert. Der klinische Versuch wird an 16 Forschungseinrichtungen in den USA mit 130 Probanden durchgeführt. Die möglichen neurobiologischen Effekte von Pagoclone sollen mit fMRI untersucht werden. Die Geschäftsführung von Indevus betont, dass man diese Studie für sehr bedeutsam erachtet und den Ergebnissen mit grosser Spannung entgegensieht: " Das Stottern ist ein lähmender Zustand, für den es zur Zeit keine FDA-zugelassene Pharmakotherapie gibt und wenn erfolgreich in der Entwicklung, so hat Pagoclone das Potential die dringend benötigte Entlastung für jene Patienten zu bieten, die durch diese Störung beeinflußt werden."

Indevus besitzt seit 1994 die Lizenzrechte für das Cyclopyrrolonderivat Pagoclone, welches ursprünglich von der französischen Firma Rhône-Poulenc Rorer (RPR) entdeckt wurde. Es kann auf eine umfangreiche Datenbank aus über 10-jähriger Entwicklungszeit zurückgegriffen werden, wobei an den klinischen Studien bislang 1500 Probanden beteiligt waren.

Pagoclone soll agonistisch als GABA-A-Modulator wirken. Die Gamma-Aminobuttersäure (GABA) ist der wichtigste inhibitorische Neurotransmitter im Zentralen Nervensystem. Die inhibitorische Wirkung von GABA beruht auf einem Chlorid-Einstrom (Hyperpolarisation). Dieser Anioneneinstrom verhindert die Depolarisation der Nervenzelle, die für das Auslösen von Aktionspotentialen notwendig wäre. Auf diese Weise reduziert GABA die elektrische Erregbarkeit von Neuronen.

Bei Pagoclone hatte man im Rahmen einer klinischen Studie mit anderer Indikation bei 3 Probanden mit der Sekundärdiagnose Stottern eine drastische Symptomreduzierung beobachtet, die nach dem Absetzen des Medikaments wieder verschwand. Indevus hat daraufhin als weltweit erste Pharmafirma Patentrechte für ein Stottermedikament angemeldet und verfolgt nun Zulassungsstudien für Pagoclone.

weitere Informationen:

Homepage von Indevus Pharmaceuticals, Inc.
http://www.indevus.com/product/pagaclon ... =pagaclone

United States Patent 6855721
"Methods and compositions for alleviating stuttering"
http://www.patentstorm.us/patents/6855721-fulltext.html

EXPRESS: Examining Pagoclone for Persistent Developmental Stuttering Study
http://www.clinicaltrials.gov/ct/show/NCT00216255

Schritt für Schritt zum neuen Medikament
http://www.die-forschenden-pharma-unter ... edikament/



INDEVUS ANNOUNCES PROMISING PHASE II DATA FOR PAGOCLONE IN STUTTERING


Compound Achieves Multiple Primary and
Secondary Endpoints and is Well-Tolerated


LEXINGTON, MA, May 24, 2006 – Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced top line results from the Company’s Phase II clinical trial for pagoclone in persistent developmental stuttering. Results from the trial show that pagoclone produces 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 also shown to be well tolerated and not associated with any serious adverse events.



The Phase II trial, known as the EXPRESS study, 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.



As a result of the promising outcome of this study, the Company plans to meet with the FDA in an End of Phase II meeting to discuss the findings and its plans for further clinical development.



“Indevus has completed what we believe is the largest pharmaceutical trial ever conducted for stuttering and the results are very exciting,” stated Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. “Our results today show that stuttering, a condition with no approved pharmacological treatment, is potentially treatable with pagoclone. This study was designed as an exploratory trial to follow up on a limited number of observations of the effect of pagoclone on stuttering during previous anxiety trials. The design of the EXPRESS trial enabled us to evaluate the condition from several clinical perspectives and we believe this provides us with a strong foundation to develop a clinical plan for further development.”



Gerald A. Maguire, M.D., associate professor, department of psychiatry, University of California, Irvine School of Medicine, stated, “Being a person who stutters and a physician who researches and treats stuttering, I am very excited about the results of this trial. As an investigator on this study, I saw first hand the positive impact pagoclone can have on the lives of patients. Consistent with the results of the entire study sample, more than half of my pagoclone treated patients had a clinically meaningful decrease in the severity of their stuttering. Although there is no cure for stuttering, pagoclone holds significant promise as a well-tolerated, effective and viable treatment for the millions of Americans who stutter.”



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).



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.



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).



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.



Approximately 90% of patients continued into the open-label phase of the study in which all patients receive pagoclone. Early results of the open-label phase indicate that patients initially randomized to pagoclone have continued to show improvement in their stuttering and those initially randomized to placebo, and now receiving pagoclone, are exhibiting improvement in their condition.



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.



Nearly 3 million Americans, or approximately 1% of the adult population, are afflicted with stuttering, with more than 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 the 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.



Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology, gynecology and men's health. The Company currently markets SANCTURA® for overactive bladder and DELATESTRYL® for the treatment of male hypogonadism. The Company has multiple compounds in clinical development, including 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.



For more information on Indevus, please visit www.indevus.com.



For more information on pagoclone and stuttering, please visit www.stutteringstudy.com.



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) and SANCTURA XR(TM); 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(R); 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 patients 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: IFA Kongress in Dublin
BeitragVerfasst: So Jul 30, 2006 12:56 pm 
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Zur Zeit findet in Dublin der IFA Kongress statt. Die Arbeitsgruppe um Garald Maguire hat hier Ergebnisse der Pagoclone Studie vorgestellt.
Tom Weidig berichtet auf The Stuttering Brain vom Kongress und auch speziell zu diesem Thema.

http://thestutteringbrain.blogspot.com/


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BeitragVerfasst: So Jul 30, 2006 6:41 pm 
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Hallo Holger,

interpretiere ich den ersten Artikel richtig, das nach 4 bis 8 Wochen bei 55% der Probanden (ohne die Placebos) eine signifikante Besserung eingetreten ist?

Gruss,
Uli


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BeitragVerfasst: Mo Jul 31, 2006 8:50 am 
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was nach erkenntnissen unabhängiger beobachter einfach nur auf einem abbau der angst beruht.
und das kann man mit starkem willen und viel training auch ohne medikamente erreichen.


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BeitragVerfasst: Mo Jul 31, 2006 8:07 pm 
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Uli hat geschrieben:
Hallo Holger,

interpretiere ich den ersten Artikel richtig, das nach 4 bis 8 Wochen bei 55% der Probanden (ohne die Placebos) eine signifikante Besserung eingetreten ist?

Gruss,
Uli


Hallo Ulli,
im ersten Pressecommuniqué zur Pagoclone-Studie ist die Effektstärke nicht so umfassend beschrieben. Hier wird man sicherlich den restlichen Verlauf der Studie, die ja noch bis Jahresende läuft, abwarten wollen. Da aber bereits Gespräche mit der FDA angekündigt sind und schon Probanden für weitere klinische Studien gesucht werden, kann man davon ausgehen, dass die Resultate zuversichtlich stimmen. Prof. Maguire hat auf dem IFA Kongress in Dublin bemerkt, dass immerhin 90% der Teilnehmer den offenen Teil der Studie fortgesetzt haben.

Mit freundlichen Grüssen
Holger Stenzel


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BeitragVerfasst: Di Aug 01, 2006 9:06 am 
Und würdest Du uns noch mal die Nebenwirkungen :twisted: beschreiben ?!

Gruß ANdreas


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BeitragVerfasst: Di Aug 01, 2006 9:16 am 
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Steht ja schon da:

"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). "

Kopfschmerzen und Ermüdungserscheinungen duerften Standard sein.

Ausserdem: "As with all prior trials for pagoclone, reports of somnolence and sedation were similar between pagoclone and placebo."

Also nichts besonderes.

Die Frage ist eher: Woher stammt der Englische Text? Aus einer Pressemeldung des Pharma-Unternehmens? :)

-Uli


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BeitragVerfasst: Di Aug 01, 2006 1:57 pm 
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moin,

die frage nervt bestimmt, da sie sehr oft gestellt worden ist.
aber meine einzige hoffnung ist momentan dieses medikament(viele therapien hinter mir) - bitte jetzt nicht über das für und wider von medikamenten reden;-)

zur frage:

in wieviel jahren,kann man UNGEFÄHR damit rechnen,dass dieses medikament auf den deutschen markt kommt?


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BeitragVerfasst: Di Aug 01, 2006 5:30 pm 
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Ben hat Folgendes geschrieben:

die frage nervt bestimmt, da sie sehr oft gestellt worden ist.
aber meine einzige hoffnung ist momentan dieses medikament(viele therapien hinter mir) - bitte jetzt nicht über das für und wider von medikamenten reden;-)

Hi Ben,
mit dem Medikament wird das wohl noch etwas dauern. Und auf keinen Fall soll das die einzige Hoffnung darstellen, sondern neue Optionen und Chancen, sowie neue Erkenntnisse.
Versuchs doch mal mit dem Angebot von Andreas Starke.

Mit freundlichen Grüssen
Holger Stenzel


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BeitragVerfasst: Di Aug 01, 2006 5:43 pm 
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Uli hat geschrieben:
Die Frage ist eher: Woher stammt der Englische Text? Aus einer Pressemeldung des Pharma-Unternehmens? :)

-Uli


Hi Uli,
den Text solltest Du hier finden:

http://phx.corporate-ir.net/phoenix.zht ... highlight=

Holger


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BeitragVerfasst: Di Aug 01, 2006 7:33 pm 
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Ansprache zum NSA-Kongress 2006 in Long Beach, Ca


Gerald Maguire's Keynote Address

Gerald Maguire, M.D., delivered the keynote address at the 2006 National Stuttering Association Conference in Long Beach, California. Dr. Maguire began his presentation, “The Medical Treatment of Stuttering: A Life’s Perspective,” by discussing his own experience growing up as a person who stutters. He told the audience that he was already discovering factors that lead to fluent speech when he was just a first grader, as he would often speak as a cartoon character in order to get his words out. He also found that reading prayers in a group increased his fluency. While giving the valedictorian speech at his high school graduation, he suddenly realized that he was speaking fluently due to the echo from the speakers in the auditorium. He did not know why these factors made him fluent, and he wanted to find out. When he was ready to pursue a medical career, however, he was told that he should enter fields requiring little communication, such as radiology or pathology. But his father, also a psychiatrist, encouraged him to become a psychiatrist, and to be the one to figure out why people stutter. Thankfully for people who stutter, Dr. Maguire took his father’s advice, and now is a licensed psychiatrist and associate professor at the University of California, Irvine School of Medicine.

Dr. Maguire has been a member of NSA since 1991, and stated that the NSA has helped him to let go of many of the negative feelings he had about stuttering and allowed him to be more open about his stuttering. Dr. Maguire stated that he has come to realize that just because you are a person who stutters does not mean that you cannot be a great communicator. “Many people who stutter are great communicators,” he said, “and many fluent speakers are terrible communicators.” Dr. Maguire believes that people must choose a career that they will love, and to never let stuttering be a deciding factor.

Dr. Maguire’s presentation was more than just inspirational, however. He also brought with him very exciting news that not only are researchers coming closer to understanding the cause of stuttering, but that there is medication currently being researched that is proving to help some people stutter less severely. Dr. Maguire noted that researchers have believed that stuttering is due to a developmental difference in the brain since the 1920s. Recently, evidence is suggesting that the striatum, the area of the brain that controls the timing and initiation of speech, is less active when people who stutter speak compared to fluent speakers. Dr. Maguire has also found that people who stutter have elevated levels of dopamine in the striatum, which may be hindering the striatum from working properly.

Along with news about the possible cause of stuttering, Dr. Maguire spoke about his personal and research experiences with drugs aimed at reducing stuttering. Dr. Maguire has been taking the medication olanzapine for his own stuttering for the past eight years and estimates that his stuttering has decreased by about 50%, as has the expectancy and anxiety that used to accompany his stuttering. Although this drug is not currently approved for treating people who stutter, and does have some side-effects, it has proven to Dr. Maguire that medications can be very helpful for some people who stutter. Perhaps even more exciting is Dr. Maguire’s participation in the trials of the drug Pagoclone, which is currently being researched to become the first medication specifically used to treat stuttering. Although a larger study is needed, Dr. Maguire reported that early results have been promising. He stated that if the drug continues to show benefits for people who stutter, it may be available by prescription in three or four years. We hope that Dr. Maguire can continue coming back to the NSA to keep us updated on his exciting and life-changing research.

By Joe Klein


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BeitragVerfasst: Fr Aug 04, 2006 11:05 am 
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Und noch mehr englischer Text >>>>>>>>>>>>>>>><!

Wer hier so viel Englisch reinkopiert sollte auch eine Übersetzung ins Deutsche nicht scheuen.

Gruß Andreas W.


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BeitragVerfasst: Fr Aug 04, 2006 2:55 pm 
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Mein logischer Berater kam zu folgender Meinung:

Englischer Text ist besser als gar kein Text.

Die auf den ersten Blick verblüffende Begründung ist, dass englischen Text wenigstens einige Leute lesen können, während keinen Text niemand lesen kann.

Erscheint logisch, oder?

Andreas Starke
www.andreasstarke.de


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BeitragVerfasst: Fr Aug 04, 2006 3:00 pm 
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Andreas Weiser hat geschrieben:
Und noch mehr englischer Text >>>>>>>>>>>>>>>><!

Wer hier so viel Englisch reinkopiert sollte auch eine Übersetzung ins Deutsche nicht scheuen.

Gruß Andreas W.


Ein tip: http://babelfish.altavista.com/translate.dyn


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BeitragVerfasst: Fr Aug 04, 2006 3:30 pm 
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AndreasStarke hat geschrieben:
Mein logischer Berater kam zu folgender Meinung:

Englischer Text ist besser als gar kein Text.

Die auf den ersten Blick verblüffende Begründung ist, dass englischen Text wenigstens einige Leute lesen können, während keinen Text niemand lesen kann.

Erscheint logisch, oder?

Andreas Starke
www.andreasstarke.de


Alle Achtung, das hast du sehr treffend gesagt! Das ist sehr logisch, ich werde bei dir das logische Argumentieren lernen.

Da ist überhaupt keine Ironie oder so dabei.

Natürlich ist es ein bisschen mühsam, solch lange wissenschaftliche Texte auf Englisch zu lesen, aber wer was nicht versteht, kann ja gezielt nachfragen.

Ich meine sogar, Holger hätte in grauer Vorzeit mal Übersetzungen angefertigt oder ich hatte ihm angeboten, ihm dabei zu helfen??

Von babelfish halte ich persönlich ehrlich gesagt....... nada.......niente....... nothing. Aber jedem Tierchen sein Plaisirchen. Adrie, übersetzt du dir die Forumsbeiträge damit ins Niederländische? Versuchs mal, was kommt denn dabei so raus?


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