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All I have been able to find is this Hans.
Guilford entered into a corporate collaboration with Daiichi Radioisotope
Laboratories (DRL) in December, 1995 for the commercialization of DOPASCAN®
Injection in Japan, Korea, and Taiwan. DRL plans to initiate a Phase III
clinical trial of DOPASCAN® Injection in the second half of 2000.
This is the second half of 2000, so maybe they are having more trials, but
I can't seem to find it.
just me,
Marjorie
At 02:49 AM 09/08/2000 +0200, you wrote:
>Hi all,
>
>The DOPASCAN, DATSCAN and ALTROPANE are three DIFFERENT agents
>to diagnose PD. All three are in a different stage of development.
>- DATSCAN is approved in Europe for the market.
>- DOPASCAN is in a -to me- unclear phase after completing a trial in 1996.
>( see
>http://www.parkinson-study-group.org/Completed%20Clinical%20Trials.html )
>- ALTROPANE has just completed clinical trial Phase III.
>( see article or http://biz.yahoo.com/bw/000727/ma_boston_.html ).
>
>Hans.
>
>
>Thursday July 27, 9:29 am Eastern Time
>
>Company Press Release
>
>Boston Life Sciences' Altropane Successful in Phase III Study
>
>Parkinson's Disease Diagnostic Demonstrates Statistically Significant
>Positive Results
>
>BOSTON--(BW HealthWire)--July 27, 2000--Boston Life Sciences, Inc.
>(NASDAQ: BLSI - news) announced that the results of its Phase III clinical
>trial of
>Altropane as a diagnostic for Parkinson's Disease (``PD'') had successfully
>confirmed Altropane's ability to differentiate Parkinson's movement
>disorders (including Parkinson's Disease) from other movement disorders. The
>primary efficacy endpoints, ``Specificity'' and ``Sensitivity'' were both
>statistically significant. The Company's Phase II clinical trial previously
>demonstrated Altropane's utility in differentiating normal patients from
>those with PD.
>
>``We are delighted with these results which, we believe, document
>Altropane's ability to reliably differentiate Parkinsonian from
>non-Parkinsonian movement disorders,'' stated Dr. Marc Lanser, Chief
>Scientific Officer of BLSI. ``We believe that the results obtained in this
>study for Specificity and Sensitivity rank among the best reported for
>approved diagnostic nuclear medicine agents in general, and are further
>complemented by the excellent results achieved in our Phase II trial. It is
>widely acknowledged that the accuracy of the initial clinical diagnosis of
>PD by physicians needs to be improved. There is no other diagnostic for PD
>in the U.S., either approved or in active clinical trials. We believe,
>therefore, that Altropane could be a unique new and effective tool in
>increasing the reliability of initial diagnosis, and thus aid in the
>determination of appropriate therapy,'' added Dr. Lanser.
>
>The multi-center Phase III study was designed to assess the Sensitivity and
>Specificity of Altropane-SPECT scanning in a sample population
>representative of those individuals that consult with neurologists or
>internists for undiagnosed movement disorders. The study enrolled 95
>subjects having the clinical diagnosis of Parkinsonian Syndrome (``PS'') and
>70 patients having non-Parkinsonian Syndrome movement disorders with
>clinical features similar to PS but whose symptoms are caused by something
>other than a destruction of dopamine producing cells. These clinical
>diagnoses were made by expert neurologists specializing in movement
>disorders. Altropane SPECT scans were performed on each subject and were
>reviewed by an independent three-member panel of nuclear medicine physicians
>specializing in neuroimaging, who had no knowledge of the clinical
>diagnosis. The Altropane scans were read and categorized as being consistent
>with either PS or non-PS, and were then compared to the expert clinical
>diagnosis. Specificity was 86%, Sensitivity was 75%, and overall accuracy
>was 80%. ``Since clinical diagnosis has been shown to be wrong 25-30% of the
>time, we believe that the excellent specificity shown by Altropane in this
>study is particularly important,'' noted Dr. Lanser. Only six scans (out of
>160) could not be read due to technical or other difficulties. There were no
>Altropane-related adverse events reported in the study. The Company looks
>forward to presenting the Phase III and other related data to the FDA.
>However, there can be no assurance that these clinical results, or the
>related safety and manufacturing data, will be sufficient for the filing of
>an NDA or for approval of the product.
>
>BLSI is developing novel diagnostics and therapeutics for Parkinson's
>Disease (PD) and Attention Deficit Hyperactivity Disorder (ADHD) as well as
>treatments for cancer, autoimmune disease, and central nervous system
>disorders. BLSI's products in development include: Altropane, a radioimaging
>agent for the diagnosis of PD and ADHD; Troponin I, a naturally-occurring
>anti-angiogenesis factor for the treatment of solid tumors; AF-1 and
>Inosine, nerve growth factors for the treatment of acute and chronic CNS
>disorders; novel therapies for the treatment of PD and ADHD; and
>transcription factors that may control the expression of molecules
>associated with autoimmune disease and allergies.
>
>Statements made in this press release other than statements of historical
>fact represent forward-looking statements. Such statements include, without
>limitation, statements regarding expectations or beliefs as to future
>results or events, such as the expected timing and results of clinical
>trials, discussions with regulatory agencies, schedules of IND, NDA and all
>other regulatory submissions, the timing of product introductions, the
>possible approval of products, and the market size and possible advantages
>of the Company's products. All such forward-looking statements involve
>substantial risks and uncertainties, and actual results may vary materially
>from these statements. Factors that may affect future results include: the
>availability and adequacy of financial resources, the ability to obtain
>intellectual property protection, delays in the regulatory or development
>processes, results of scientific data from clinical trials, the outcome of
>discussions with potential partners, regulatory decisions, market acceptance
>of the Company's products, and other possible risks and uncertainties that
>have been noted in reports filed by the Company with the Securities and
>Exchange Commission, including the Company's Annual Report on Form 10-K.
>
>Contact:
>
> Boston Life Sciences, Inc.
> Maria Zapf
> 617.425.0200, ext.17
> www.bostonlifesciences.com
> or
> The Trout Group
> Brandon Lewis
> 212.477.9007, ext. 15
> www.troutgroup.com
> or
> Boston Life Sciences, Inc.
> Marc Lanser, MD
> 617.425.0200
> or
> Schwartz Communications
> Jim Weinrebe
> 781.684.0770
> www.schwartz-pr.com
>
>Copyright © 2000 Yahoo! All Rights Reserved.
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Week 4 June 1999, Week 3 June 1999, Week 2 June 1999, Week 1 May 1999, Week 5 May 1999, Week 4 May 1999, Week 3 May 1999, Week 2 May 1999, Week 1 April 1999, Week 5 April 1999, Week 4 April 1999, Week 3 April 1999, Week 2 April 1999, Week 1 March 1999, Week 5 March 1999, Week 4 March 1999, Week 3 March 1999, Week 2 March 1999, Week 1 February 1999, Week 4 February 1999, Week 3 February 1999, Week 2 February 1999, Week 1 January 1999, Week 5 January 1999, Week 4 January 1999, Week 3 January 1999, Week 2 January 1999, Week 1 December 1998, Week 5 December 1998, Week 4 December 1998, Week 3 December 1998, Week 2 December 1998, Week 1 November 1998, Week 5 November 1998, Week 4 November 1998, Week 3 November 1998, Week 2 November 1998, Week 1 October 1998, Week 5 October 1998, Week 4 October 1998, Week 3 October 1998, Week 2 October 1998, Week 1 September 1998, Week 5 September 1998, Week 4 September 1998, Week 3 September 1998, Week 2 September 1998, Week 1 August 1998, Week 5 August 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Week 4 October 1997, Week 3 October 1997, Week 2 October 1997, Week 1 September 1997, Week 5 September 1997, Week 4 September 1997, Week 3 September 1997, Week 2 September 1997, Week 1 August 1997, Week 5 August 1997, Week 4 August 1997, Week 3 August 1997, Week 2 August 1997, Week 1 July 1997, Week 5 July 1997, Week 4 July 1997, Week 3 July 1997, Week 2 July 1997, Week 1 June 1997, Week 5 June 1997, Week 4 June 1997, Week 3 June 1997, Week 2 June 1997, Week 1 May 1997, Week 5 May 1997, Week 4 May 1997, Week 3 May 1997, Week 2 May 1997, Week 1 April 1997, Week 5 April 1997, Week 4 April 1997, Week 3 April 1997, Week 2 April 1997, Week 1 March 1997, Week 5 March 1997, Week 4 March 1997, Week 3 March 1997, Week 2 March 1997, Week 1 February 1997, Week 5 February 1997, Week 4 February 1997, Week 3 February 1997, Week 2 February 1997, Week 1 January 1997, Week 5 January 1997, Week 4 January 1997, Week 3 January 1997, Week 2 January 1997, Week 1 December 1996, Week 5 December 1996, Week 4 December 1996, Week 3 December 1996, Week 2 December 1996, Week 1 November 1996, Week 5 November 1996, Week 4 November 1996, Week 3 November 1996, Week 2 November 1996, Week 1 October 1996, Week 5 October 1996, Week 4 October 1996, Week 3 October 1996, Week 2 October 1996, Week 1 September 1996, Week 5 September 1996, Week 4 September 1996, Week 3 September 1996, Week 2 September 1996, Week 1 August 1996, Week 5 August 1996, Week 4 August 1996, Week 3 August 1996, Week 2 August 1996, Week 1 July 1996, Week 5 July 1996, Week 4 July 1996, Week 3 July 1996, Week 2 July 1996, Week 1 June 1996, Week 5 June 1996, Week 4 June 1996, Week 3 June 1996, Week 2 June 1996, Week 1 May 1996, Week 5 May 1996, Week 4 May 1996, Week 3 May 1996, Week 2 May 1996, Week 1 April 1996, Week 5 April 1996, Week 4 April 1996, Week 3 April 1996, Week 2 April 1996, Week 1 March 1996, Week 5 March 1996, Week 4 March 1996, Week 3 March 1996, Week 2 March 1996, Week 1 February 1996, Week 5 February 1996, Week 4 February 1996, Week 3 February 1996, Week 2 February 1996, Week 1 January 1996, Week 5 January 1996, Week 4 January 1996, Week 3 January 1996, Week 2 January 1996, Week 1 December 1995, Week 5 December 1995, Week 4 December 1995, Week 3 December 1995, Week 2 December 1995, Week 1 November 1995, Week 5 November 1995, Week 4 November 1995, Week 3 November 1995, Week 2 November 1995, Week 1 October 1995, Week 5 October 1995, Week 4 October 1995, Week 3 October 1995, Week 2 October 1995, Week 1 September 1995, Week 5 September 1995, Week 4 September 1995, Week 3 September 1995, Week 2 September 1995, Week 1 August 1995, Week 5 August 1995, Week 4 August 1995, Week 3 August 1995, Week 2 August 1995, Week 1 July 1995, Week 5 July 1995, Week 4 July 1995, Week 3 July 1995, Week 2 July 1995, Week 1 June 1995, Week 5 June 1995, Week 4 June 1995, Week 3 June 1995, Week 2 June 1995, Week 1 May 1995, Week 5 May 1995, Week 4 May 1995, Week 3 May 1995, Week 2 May 1995, Week 1 April 1995, Week 5 April 1995, Week 4 April 1995, Week 3 April 1995, Week 2 April 1995, Week 1 March 1995, Week 5 March 1995, Week 4 March 1995, Week 3 March 1995, Week 2 March 1995, Week 1 February 1995, Week 4 February 1995, Week 3 February 1995, Week 2 February 1995, Week 1 January 1995, Week 5 January 1995, Week 4 January 1995, Week 3 January 1995, Week 2 January 1995, Week 1 December 1994, Week 5 December 1994, Week 4 December 1994, Week 3 December 1994, Week 2 December 1994, Week 1 November 1994, Week 5 November 1994, Week 4 November 1994, Week 3 November 1994, Week 2 November 1994, Week 1 October 1994, Week 5 October 1994, Week 4 October 1994, Week 3 October 1994, Week 2 October 1994, Week 1 September 1994, Week 5 September 1994, Week 4 September 1994, Week 3 September 1994, Week 2 September 1994, Week 1 August 1994, Week 5 August 1994, Week 4 August 1994, Week 3 August 1994, Week 2 August 1994, Week 1 July 1994, Week 5 July 1994, Week 4 July 1994, Week 3 July 1994, Week 2 July 1994, Week 1 June 1994, Week 5 June 1994, Week 4 June 1994, Week 3 June 1994, Week 2 June 1994, Week 1 May 1994, Week 5 May 1994, Week 4 May 1994, Week 3 May 1994, Week 2 May 1994, Week 1 April 1994, Week 5 April 1994, Week 4 April 1994, Week 3 April 1994, Week 2 April 1994, Week 1 March 1994, Week 5 March 1994, Week 4 March 1994, Week 3 March 1994, Week 2 March 1994, Week 1 February 1994, Week 4 February 1994, Week 3 February 1994, Week 2 February 1994, Week 1 February 1994 January 1994 December 1993 November 1993
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