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Manufacturing Agreement for Radiation-Protection Compound

By MedImaging staff writers
Posted on 14 Nov 2006
Cleveland BioLabs, Inc. (CLBI; Cleveland, OH, USA), and SynCo Bio Partners B.V. (Amsterdam, The Netherlands), a leading biopharmaceutical manufacturer, have completed the transfer of technology in their joint effort to produce CBLI's leading radioprotection molecule, under current good manufacturing practices (cGMP) specifications and have signed an agreement to produce sufficient amounts for clinical trials and the commercial market.

Protectan CBLB502, Cleveland BioLabs's major product, demonstrated exceptional effectiveness in a recent study, when it rescued more than 70% of lethally irradiated primates and considerably delayed death for the others.

CBLI's development strategy for CBLB502 complies with recently adopted U.S. Food and Drug Administration (FDA) rules for investigational drugs that address situations, such as radiation injury, where it would be unethical to perform efficacy studies in humans. Whereas phase II and phase III human clinical trials are typically required for the marketing approval of an investigational drug, under the new FDA rule, Protectan CBLB502 would be considered for approval for radiation protection based on phase I safety studies in humans and efficacy studies in relevant primates.

Under the terms of the agreement, SynCo will work with CBLI to develop the manufacturing process based on pilot studies conducted by the company and product CBLB502 under cGMP standards for phase I safety testing in humans and commercial release. The SynCo facility has the capacity to manufacture considerable doses of CBLB502 for potential national stockpiling.

Dr. Michael Fonstein, Cleveland BioLabs's CEO stated, "This is an important milestone for Cleveland BioLabs. We are impressed by SynCo's track record in process development and GMP manufacturing and believe that they are the right manufacturing partner to assist us in the next phases of development. CBLB502's outstanding success as a radioprotectant in mouse and monkey clinical models provides us with confidence that we will have sufficient data to submit an NDA for biodefense applications to the FDA within 24 months.”

SynCo provides a broad range of GMP manufacturing services including bioprocess development, API manufacture for clinical trials and market supply, and aseptic filling and lyophilization. Cleveland BioLabs is a drug discovery and development company utilizing its proprietary discoveries about programmed cell death to treat cancer and protect normal tissues from exposure to radiation and other stresses.



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95 (40.054321289062): SELECT show_live FROM jos_com_show_setting LIMIT 1
96 (42.915344238281): SELECT show_live FROM jos_com_show_setting LIMIT 1
97 (38.14697265625): SELECT show_live FROM jos_com_show_setting LIMIT 1
98 (85.115432739258): SELECT show_live FROM jos_com_show_setting LIMIT 1
99 (46.014785766602): SELECT show_live FROM jos_com_show_setting LIMIT 1
100 (42.915344238281): SELECT show_live FROM jos_com_show_setting LIMIT 1
101 (39.100646972656): SELECT show_live FROM jos_com_show_setting LIMIT 1
102 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1
103 (375.98609924316): SELECT show_live FROM jos_com_show_setting LIMIT 1
104 (50.067901611328): SELECT show_live FROM jos_com_show_setting LIMIT 1
105 (37.908554077148): SELECT show_live FROM jos_com_show_setting LIMIT 1
106 (!!!!! 4522.0851898193): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
107 (117.06352233887): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
108 (95.844268798828): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=212670000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
109 (!!!!! 2769.947052002): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=212670000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
110 (!!!!! 6518.1255340576): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
111 (916.0041809082): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
112 (!!!!! 5943.0599212646): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=212670000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
113 (!!!!! 1158.9527130127): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.id=212670000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
114 (!!!!! 4966.0205841064): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
115 (!!!!! 1006.8416595459): SELECT dp.name, dp.id, dp2.name as channel, ex.name as author_name, ex.specialization, ex.images FROM jos_deeppockets as dp LEFT JOIN jos_experts as ex ON ex.id = dp.author LEFT JOIN jos_deeppockets as dp2 ON dp2.id = dp.fid WHERE dp.author != 0 AND dp.cat = 10 AND dp.published = 1 AND ( (dp.fid = 294743300) OR (dp.fid = 294743301) OR (dp.fid = 294743302) OR (dp.fid = 294743303) OR (dp.fid = 294743304) OR (dp.fid = 294743305) OR (dp.fid = 294743306) OR (dp.fid = 294743307) OR (dp.fid = 294743308) OR (dp.fid = 294743309) OR (dp.fid = 294743310) ) ORDER BY RAND() LIMIT 1
116 (!!!!! 1734.0183258057): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
117 (499.96376037598): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
118 (!!!!! 4215.9557342529): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
119 (148.05793762207): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
120 (!!!!! 1797.9145050049): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
121 (!!!!! 1971.960067749): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
122 (520.94459533691): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
123 (584.84077453613): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
124 (!!!!! 4318.9525604248): SELECT * FROM trending_articles WHERE `journal_id` = 10 AND `timestamp` <= NOW() + INTERVAL 7 DAY ORDER BY `order`
125 (!!!!! 122689.00871277): SELECT * FROM jos_deeppockets WHERE jos_deeppockets.cat = 10 AND jos_deeppockets.type = 'deeppockets_item' AND jos_deeppockets.published = 1 AND jos_deeppockets.created + INTERVAL 14 DAY >= NOW() ORDER BY jos_deeppockets.hits DESC LIMIT 7
126 (!!!!! 10967.016220093): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=212670000 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=212670000 AND type='deeppockets_item' AND published='1' LIMIT 1
127 (!!!!! 28599.977493286): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
128 (!!!!! 1938.1046295166): ( SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.video != '' AND dp.video_source != '' AND dp.cat = 10 AND dp.published = 1 AND dp.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) UNION ( SELECT dpa.id, dpa.name, dpa.title, dpa.video, dpa.video_source, dpa.created FROM jos_deeppockets_archive AS dpa WHERE dpa.video != '' AND dpa.video_source != '' AND dpa.cat = 10 AND dpa.published = 1 AND dpa.type != 'deeppockets_item_link' ORDER BY created DESC LIMIT 3 ) ORDER BY created DESC LIMIT 3
129 (481.84394836426): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
130 (156.87942504883): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803337 LIMIT 1
131 (947.95227050781): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
132 (61.03515625): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294803276 LIMIT 1
133 (342.13066101074): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
134 (57.93571472168): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets_archive AS dp WHERE dp.id = 294803276 LIMIT 1
135 (66.041946411133): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
136 (46.014785766602): SELECT dp.id, dp.name, dp.title, dp.video, dp.video_source, dp.created FROM jos_deeppockets AS dp WHERE dp.id = 294802958 LIMIT 1
137 (!!!!! 7646.0838317871): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
138 (!!!!! 7932.9013824463): SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
139 (!!!!! 8335.1135253906): SELECT name FROM jos_deeppockets WHERE id=217
140 (!!!!! 7703.0658721924): SELECT name FROM jos_deeppockets WHERE id=217
141 (!!!!! 8177.9956817627): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))217((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
142 (!!!!! 7740.9744262695): SELECT *, DATE_FORMAT(publish_up,'%d %b %Y') AS date_publish_up, DATE_FORMAT(publish_down,'%d %b %Y') AS date_publish_down FROM jos_events WHERE state=1 AND publish_up > NOW() and extra_info REGEXP '((;)|(^))217((;)|($))' AND catid IN (0,110) ORDER BY publish_up ASC LIMIT 3
143 (!!!!! 7818.9373016357): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
144 (!!!!! 7753.849029541): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
145 (!!!!! 24880.886077881): TRUNCATE TABLE jos_trademed_module
146 (!!!!! 3433.9427947998): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=212670000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
147 (!!!!! 5571.8421936035): SELECT dp.*, ch.title as channel, exp.name as author_name, exp.specialization as author_specialization, exp.images as author_photo FROM jos_deeppockets_archive as dp LEFT JOIN jos_experts as exp ON exp.id = dp.author LEFT JOIN jos_deeppockets as ch ON dp.fid = ch.id WHERE 1=1 AND dp.cat=10 AND dp.id=212670000 AND (dp.type='deeppockets_item' OR dp.type='deeppockets_item_link') AND dp.published='1' LIMIT 1
148 (592.94700622559): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
149 (84.161758422852): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND (type='deeppockets_item' OR type='deeppockets_item_link') AND published='1' LIMIT 1
150 (96.08268737793): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
151 (107.0499420166): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
152 (!!!!! 7282.9723358154): SELECT jos_item.* FROM jos_item INNER JOIN jos_number ON jos_item.numberID=jos_number.id WHERE 1=1 AND (jos_item.imgMini<>'') AND jos_item.type='L' AND jos_item.numberID= ( SELECT jos_number.id FROM jos_number WHERE jos_number.journalID IN (10) and jos_number.id in (select distinct jos_number.id from jos_number join jos_item on jos_item.numberid=jos_number.id where jos_item.type='P') ORDER BY (CONVERT(SUBSTRING(issue,1,2),SIGNED) + (CONVERT(SUBSTRING(issue,3,2),SIGNED)*100)) DESC LIMIT 0,1 ) ORDER BY RAND() DESC LIMIT 6
153 (701.1890411377): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
154 (293.01643371582): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
155 (!!!!! 1132.9650878906): SELECT fid FROM jos_deeppockets WHERE cat=10 AND id=212670000 AND type='deeppockets_item' AND published='1' union SELECT fid FROM jos_deeppockets_archive WHERE cat=10 AND id=212670000 AND type='deeppockets_item' AND published='1' LIMIT 1
156 (339.03121948242): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=217 or channel_id is null)
157 (!!!!! 4364.013671875): select distinct links.* from jos_textlinks links join jos_textlinks_placement placement on links.id=placement.link_id where journal_id=(10) and (channel_id=217 or channel_id is null)
158 (!!!!! 7770.0614929199): SELECT livesite FROM jos_dp_categories WHERE id=10 AND published='1' LIMIT 1
159 (!!!!! 7351.1600494385): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
160 (!!!!! 3876.2092590332): SELECT * FROM jos_deeppockets WHERE 1=1 AND id=212670000 AND published='1' union SELECT * FROM jos_deeppockets_archive WHERE 1=1 AND id=212670000 AND published='1' LIMIT 1
161 (!!!!! 7728.099822998): select jos_twitters.link from jos_twitters where cat=10
162 (!!!!! 7913.1126403809): select jos_facebook.link from jos_facebook where cat=10
163 (!!!!! 7965.087890625): select jos_google_plus.link from jos_google_plus where cat=10
164 (!!!!! 7889.986038208): select jos_linkedin.link from jos_linkedin where cat=10