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	<title>MS News Today &#187; maestro-01</title>
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	<description>Posting fresh info about MS, for people with MS and their supporters</description>
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		<title>Dirucotide Does Not Meet Primary Endpoint in Phase III Trial In Secondary Progressive MS</title>
		<link>http://www.msnewstoday.com/dirucotide-does-not-meet-primary-endpoint-in-phase-iii-trial-in-secondary-progressive-ms/</link>
		<comments>http://www.msnewstoday.com/dirucotide-does-not-meet-primary-endpoint-in-phase-iii-trial-in-secondary-progressive-ms/#comments</comments>
		<pubDate>Mon, 27 Jul 2009 23:46:18 +0000</pubDate>
		<dc:creator>caroline</dc:creator>
				<category><![CDATA[pipeline]]></category>
		<category><![CDATA[bioms medical corp]]></category>
		<category><![CDATA[dirucotide]]></category>
		<category><![CDATA[lilly]]></category>
		<category><![CDATA[maestro-01]]></category>
		<category><![CDATA[ph 3 trial discontinued]]></category>

		<guid isPermaLink="false">http://www.msnewstoday.com/?p=461</guid>
		<description><![CDATA[July 27, 2009 – Eli Lilly and Company and BioMS Medical Corp. today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as [...]]]></description>
			<content:encoded><![CDATA[<p><strong>July 27, 2009 </strong>– Eli Lilly and Company and BioMS Medical Corp. today announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study.</p>
<p style="font-family: Arial; font-style: normal; font-variant: normal; font-weight: normal; font-size: 12px; line-height: normal; font-size-adjust: none; font-stretch: normal; color: #636363;">The data also showed that dirucotide was generally well tolerated. There were no unexpected safety or tolerability issues. The most common side effect reported was injection site reaction. More details of the MAESTRO-01 study results are expected to be presented at a medical conference later this year.</p>
<p style="font-family: Arial; font-style: normal; font-variant: normal; font-weight: normal; font-size: 12px; line-height: normal; font-size-adjust: none; font-stretch: normal; color: #636363;">Lilly and BioMS also announced they would discontinue ongoing clinical trials – including MAESTRO-02 and MAESTRO-03 – and review the available data from these studies. MAESTRO-02 is an open-label follow-on study to MAESTRO-01. MAESTRO-03 is a 510-patient U.S. Phase III clinical trial designed to evaluate dirucotide for the treatment of SPMS that completed enrollment in August 2008. Lilly and BioMS will inform regulatory agencies and provide instructions to investigators outlining the process for discontinuing the studies. Patients involved in studies who have questions should contact their study investigator.</p>
<p style="font-family: Arial; font-style: normal; font-variant: normal; font-weight: normal; font-size: 12px; line-height: normal; font-size-adjust: none; font-stretch: normal; color: #636363;">“The MAESTRO-01 study was well designed and executed, and we believe these data, while disappointing, are very instructive for us and for the larger MS community,” said John Hayes, vice president of Lilly Research Laboratories. “We look forward to further conversations with BioMS Medical about this project.”</p>
<p style="font-family: Arial; font-style: normal; font-variant: normal; font-weight: normal; font-size: 12px; line-height: normal; font-size-adjust: none; font-stretch: normal; color: #636363;">&#8220;We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data and the available data from MAESTRO-02 and MAESTRO-03 to determine our next steps,” said Kevin Giese, President and CEO of BioMS Medical. &#8220;We are fortunate to have suitable resources in place to remain flexible to pursue whatever options emerge once we understand these results more fully.”</p>
<p style="font-family: Arial; font-style: normal; font-variant: normal; font-weight: normal; font-size: 12px; line-height: normal; font-size-adjust: none; font-stretch: normal; color: #636363;"><strong>BioMS Medical Webcast </strong><br />
Participants may listen to a discussion of the outcome of the MAESTRO-01 study by Kevin Giese, President and CEO of BioMS Medical. The audio webcast is accessible through the Company’s web site at <a href="http://www.biomsmedical.com/" target="_blank">www.biomsmedical.com</a>.</p>
<p style="font-family: Arial; font-style: normal; font-variant: normal; font-weight: normal; font-size: 12px; line-height: normal; font-size-adjust: none; font-stretch: normal; color: #636363;"><strong>About MAESTRO-01 </strong><br />
MAESTRO-01 was a multi-center, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of dirucotide in patients with SPMS. The study was conducted in Canada and nine countries in Europe and included 612 patients being administered either dirucotide or placebo intravenously every six months for a period of two years.</p>
<p>The primary clinical endpoint for the trial was defined as a statistically significant increase in the time to progression of the disease, as measured by the EDSS, in patients with HLA-DR2 and/or HLA-DR4 immune response genes. It is estimated that up to 70% of all multiple sclerosis patients are HLA-DR2 and/or HLA-DR4 positive. The EDSS is the standard for measuring impairment in MS.</p>
<p style="font-family: Arial; font-style: normal; font-variant: normal; font-weight: normal; font-size: 12px; line-height: normal; font-size-adjust: none; font-stretch: normal; color: #636363;">View full post here:<a href="http://mail.google.com/mail/?zx=1uxsgprxumqg3&amp;shva=1#inbox/122be0fccf8636c5" target="_blank"> http://mail.google.com/mail/?zx=1uxsgprxumqg3&amp;shva=1#inbox/122be0fccf8636c5</a></p>
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		<title>SPMS Treatment Update: Spotlight on dirucotide (BioMS Medical Corp.)</title>
		<link>http://www.msnewstoday.com/spms-treatment-update-spotlight-on-dirucotide-bioms-medical-corp/</link>
		<comments>http://www.msnewstoday.com/spms-treatment-update-spotlight-on-dirucotide-bioms-medical-corp/#comments</comments>
		<pubDate>Tue, 17 Mar 2009 15:09:09 +0000</pubDate>
		<dc:creator>caroline</dc:creator>
				<category><![CDATA[pipeline]]></category>
		<category><![CDATA[bioms medical corp]]></category>
		<category><![CDATA[dirucotide]]></category>
		<category><![CDATA[maestro-01]]></category>
		<category><![CDATA[phase iii]]></category>
		<category><![CDATA[secondary progressive multiple sclerosis]]></category>
		<category><![CDATA[spms]]></category>

		<guid isPermaLink="false">http://www.msnewstoday.com/?p=104</guid>
		<description><![CDATA[BioMS Medical Announces 2008 Year End Results Edmonton, Alberta, March 17, 2009 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis [...]]]></description>
			<content:encoded><![CDATA[<p>BioMS Medical Announces 2008 Year End Results</p>
<p>Edmonton, Alberta, March 17, 2009 – BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced financial and operational results for the year ended December 31, 2008.</p>
<p>“Dirucotide has demonstrated the ability to safely affect MS progression in previous studies and we look forward to the results of the Canadian/European trial (MAESTRO-01) in the second half of this year,” said Kevin Giese, President and CEO of BioMS Medical. “Our hope is that the results of this trial will confirm that dirucotide is able to significantly slow the progression of MS, specifically in patients with secondary progressive multiple sclerosis.”</p>
<p>Currently, BioMS is conducting two clinical trials and one open-label follow-on trial of dirucotide for the treatment of secondary progressive MS (SPMS):</p>
<p>• MAESTRO-01: On January 22, 2007, BioMS announced that this pivotal phase III trial, being conducted in Canada and Western Europe, had completed full recruitment of 611 SPMS patients at 47 trial sites in ten countries. To date, there have been nine positive safety reviews from the Data Safety Monitoring Board (DSMB). The primary clinical endpoint for MAESTRO-01 (and MAESTRO-03) is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes.</p>
<p>On August 13, 2008, the DSMB conducted a scheduled interim analysis of efficacy and safety and recommended that the trial continue to completion. The interim analysis evaluated the first 200 patients to complete MAESTRO-01 and assessed the likelihood of the study reaching its primary endpoint at the end of the trial. Based on the DSMB decision, Eli Lilly and Company (Lilly) provided a US $10 million milestone payment to BioMS as part of the terms of the licensing and collaboration agreement.</p>
<p>BioMS anticipates MAESTRO-01 will be completed in 2009 with results from the trial expected in the second half of this year.</p>
<p>• MAESTRO-02: Eligible patients who have successfully completed MAESTRO-01 may choose to receive dirucotide on an un-blinded basis in this open-label follow-on study. To date, approximately 95% of the eligible patients who have successfully completed the MAESTRO-01 trial have enrolled in this follow-on study.</p>
<p>• MAESTRO-03: Enrollment was initiated in June, 2007 and completed on August 1, 2008 for this pivotal U.S. phase III trial of approximately 510 SPMS patients at 67 sites across the U.S. To date, the DSMB has conducted three reviews of the data from this trial and recommended it continue. The next DSMB review is expected to take place in the second quarter of fiscal 2009.</p>
<p>• MINDSET-01: MINDSET-01 was a randomized, double-blind study that recruited 218 relapsing-remitting MS patients at 24 trial sites in six countries across Europe. BioMS recently announced that the top line results of this exploratory study did not meet its primary endpoint of effecting annualized relapse rate or associated secondary magnetic resonance imaging (MRI) endpoints. Dirucotide did meet certain secondary endpoints related to the progression of the disease, including mean change from baseline in the EDSS and the MS Functional Composite (MSFC) score. Changes in EDSS and MSFC are primary and secondary outcomes in the ongoing phase III SPMS trials.</p>
<p>The data also showed that dirucotide was generally well tolerated. The most common side effects reported were redness and burning sensation at the injection site. No patients withdrew due to adverse events.</p>
<p>Eligible patients in this trial are now receiving dirucotide on an un-blinded basis to the end of their 27th month in the trial.</p>
<p>Licensing and Development Agreement with Lilly<br />
On December 17, 2007, BioMS entered into a licensing and development agreement (the “Agreement”) granting Lilly exclusive worldwide rights to dirucotide. The transaction closed on January 25, 2008 and BioMS received an upfront payment of US $87 million. In September 2008, BioMS received a development milestone payment of US $10 million as a result of the positive interim analysis from the DSMB for MASESTRO-01. BioMS has the potential to receive future development and sales milestones up to US $400 million and escalating royalties on sales if dirucotide is commercialized.</p>
<p>Not later than sixty (60) days following receipt of the final written report of the results of the MAESTRO-01 trial, Lilly shall notify BioMS in writing whether Lilly will terminate the Agreement or alternatively Lilly shall bear 100% of any and all continuing development costs incurred by Lilly or BioMS for dirucotide.</p>
<p>HYC750 and BioCyDex<br />
On May 9, 2008, BioMS entered into a Royalty and Assignment Agreement with Orcrist Bio. Inc. for HYC750, a technology based on hyaluronic acid that has a number of potential therapeutic uses and is being developed as a treatment for the side effects of chemotherapy. BioMS held an exclusive worldwide license to HYC750 from the University of Alberta. As a result of the Royalty and Assignment Agreement, BioMS terminated its license with the University of Alberta and the University entered into a direct license with Orcrist. BioMS assigned all BioMS owned patents relating to HYC750 and transfered all HYC750 assets to Orcrist. Under the terms of the agreement, BioMS will receive certain milestone payments in addition to a royalty on net sales of products which otherwise would have infringed on patents related to the HYC750 technology.</p>
<p>BioMS also ceased all development activities with respect to BioCyDex. Future development or licensing activities will be the responsibility of BioCyDex.</p>
<p>Financial Results<br />
The consolidated net loss for the year ended December 31, 2008 was $0.5 million or ($0.01) per share compared with a consolidated net loss of $47.2 million or ($0.56) per share for the previous year. The consolidated net income for the three months ended December 31, 2008 was $0.3 million or $0.01 per share compared with a net loss of ($11.7) million or ($0.13) per share for the previous year.</p>
<p>Revenue of $52.6 million was recorded for the year ended December 31, 2008 compared to $Nil for the year ended December 31, 2007. The revenue is the result of the amortization of the upfront payment and development milestone received from the Agreement with Lilly. Investment income earned on funds invested for the year ended December 31, 2008 increased to $2.4 million from $1.6 million for 2007 due to the increase in cash and cash equivalents as a result of the Agreement with Lilly. The increase was partially offset by a general reduction in interest rates experienced in the market. The investment income is earned from the short-term investment of cash reserves in low risk term deposits and bankers acceptance notes.</p>
<p>Total consolidated expenses for the year ended December 31, 2008 were $61.9 million compared with $48.0 million for 2007. Total consolidated expenses for the three months ended December 31, 2008 totaled $16.5 million as compared to $12.1 million in the same quarter the previous year.</p>
<p>Research and development expenses for the year ended December 31, 2008 totaled $46.5 million compared with $38.9 million in 2007. Research and development expenses were $13.9 million for the three months ended December 31, 2008 compared to $9.3 million for the same quarter the previous year. The increase in expenses was the net result of: achieving full enrolment of clinical sites and patients in the MAESTRO-03 trial; increased costs for the MAESTRO-02 trial as patients enter the trial; reduced costs of the MAESTRO-01 and MINDSET-01 trials as more patients complete these trials; a decrease in drug manufacturing expenses as the manufacture of validation batches is completed; a licensing bonus payment related to the Agreement with Lilly, and; additional expenses related to alliance management and support.</p>
<p>About BioMS Medical Corp.<br />
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, dirucotide, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for Secondary Progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. In December 2007, BioMS entered into a licensing and development agreement granting Eli Lilly and Company exclusive worldwide rights to dirucotide in exchange for an $87 million upfront payment, milestone payments and escalating royalties on sales. For further information please visit our website at http://www.biomsmedical.com </p>
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