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BLX-155

1. [verwijderd] 14 juli 2007 21:57

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   Partner 2 produkt
   
   FOR IMMEDIATE RELEASE
   BIOLEX THERAPEUTICS PRESENTS PRECLINICAL RESULTS FOR CLOT
   BUSTER BLX-155 AT THE INTERNATIONAL SOCIETY ON THROMBOSIS AND
   HAEMOSTASIS MEETING
   
   -- Clinical Development Program for Also Announced --
   PITTSBORO, NORTH CAROLINA, JULY 13, 2007 - Biolex Therapeutics announced
   today that Company researchers have presented results at the XXIst Congress of The
   International Society on Thrombosis and Haemostasis (ISTH) in Geneva, Switzerland
   demonstrating that full-length recombinant plasmin (BLX-155) produced with the Company’s
   proprietary LEX SystemSM is indistinguishable from human plasma-derived plasmin in
   characterization and activity. Full-length, active plasmin has been proposed as a potential
   thrombolytic agent for several decades, and the LEX System is the first recombinant
   expression system reported to produce commercially viable levels of full-length plasmin.
   This achievement provides Biolex the opportunity to pursue development and
   commercialization of a therapeutic protein with a recognized mechanism of action for which
   development historically has been blocked by production challenges. The Company also
   announced that clinical studies of BLX-155 are planned to commence in the first half of 2008.
   Scientific Basis for Recombinant Full-Length Plasmin (BLX-155)
   BLX-155, a full-length recombinant plasmin, is a direct-acting thrombolytic agent designed to
   dissolve blood clots in patients with diseases or conditions that include acute peripheral
   arterial disease, deep vein thrombosis, and hemodialysis graft thrombosis, each of which
   currently lacks a safe and effective therapy. Plasmin is the key enzyme in the human body
   that dissolves the fibrin component of blood clots. In fact, dissolution of blood clots, whether
   it is accomplished naturally within the body or through treatment with indirect-acting drugs
   like tPA, is ultimately accomplished by plasmin. Researchers believe that plasmin’s accepted
   role in dissolving clots makes it the logical basis for a direct-acting thrombolytic, as it
   combines the potential for superior clot dissolution with substantial safety advantages.
   Full-length plasmin is a complex protein whose structure includes five kringle domains that
   provide a high affinity and specificity for binding to the fibrin component of blood clots.
   Biolex believes that full-length plasmin’s high affinity to fibrin may result in a therapy that is
   more effective than tPA, and also more effective than other direct-acting thrombolytics in
   development such as truncated forms of plasmin and alfimeprase, each of which lacks the five
   kringle domains of full-length plasmin. Additionally, as a naturally occurring protein,
   plasmin is regulated by a number of inhibitors within the body that exist in high quantities and
   serve to rapidly inactivate any plasmin that circulates beyond the immediate site of the clot.
   This safety mechanism may decrease the risk of bleeding complications associated with the
   - more -
   
   July 13, 2007
   Page2
   
   therapeutic administration of tPA and alfimeprase. The combination of plasmin’s high
   affinity to fibrin and the presence of high levels of circulating plasmin inhibitors may result in
   less bleeding complications than are associated with tPA and direct thrombolytics under
   development and potentially could result in a therapy with a higher therapeutic index.
   Preclinical Results and Clinical Development Plans
   In a presentation at the ISTH meeting entitled “Recombinant Human Plasmin Produced in
   Lemna Minor,” Biolex researchers presented data demonstrating that BLX-155, recombinant
   full-length plasmin produced using the LEX System, is indistinguishable from human plasmaderived
   plasmin in characterization, activity and inhibition by alpha 2 antiplasmin. These
   results are significant, due to the fact that the production of full-length human plasmin at
   commercially viable levels has not been reported with any traditional recombinant production
   system. As a result of these limitations, full-length plasmin previously could only be derived
   from human donor plasma, but this source is limited and carries the potential for transmitting
   human pathogens.
   “The development of BLX-155 using the LEX System may allow exploitation of the natural
   binding, efficacy and safety attributes of native plasmin without the limitations or risks
   associated with truncated plasmin, plasma-derived plasmin, plasminogen activators, or
   alfimeprase,” said Jan Turek, President and CEO of Biolex. “Plasmin has been shown to be
   more effective in dissolving clots than tPA in both in vitro and in vivo preclinical models, and
   therefore we are excited to proceed with the clinical development of BLX-155. In addition,
   preclinical animal studies assessing bleeding complications have shown that plasmin has a
   substantially lower risk of bleeding than tPA, demonstrating the potential of BLX-155 to
   provide a safety advantage to patients suffering from blood clots.”
   The Company also announced that clinical testing of BLX-155 is planned to commence in the
   first half of 2008 under a United States Investigational New Drug (IND) Application. The
   planned Phase 1 trial is expected to be a dose-escalation study conducted in hemodialysis
   graft thrombosis patients. The study is designed to provide data regarding the safety of BLX-
   155 while allowing for an assessment of clot dissolution in this medical condition. A planned
   Phase 2a study will be conducted in deep vein thrombosis patients and is expected to
   commence in the second half of 2008, after evaluation of the initial safety results from the
   Phase 1 study. These two trials are designed to facilitate the exploration of a wide range of
   doses for BLX-155, including the higher doses expected to be evaluated if acute peripheral
   arterial disease is selected as an indication for development.
   BLX-155 is an investigational therapeutic candidate and has not been approved for sale by the
   United States Food and Drug Administration or any international regulatory agency.
   - more -
   
   July 13, 2007
   Page 3
   
   About Biolex Therapeutics
   Biolex Therapeutics is developing and commercializing therapeutic proteins based on its
   proprietary LEX SystemSM, an expression system that enables the commercially-viable
   production of hard-to-make proteins and the optimization of monoclonal antibodies. The
   Company is developing a proprietary pipeline of biologic product candidates that have known
   mechanisms of action and have the potential to provide a reduced risk profile while targeting
   large, proven pharmaceutical markets. Biolex’s lead candidate, Locteron™, under joint
   development with OctoPlus N.V., is in Phase 2 clinical trials as a controlled-release interferon
   alfa for the treatment of hepatitis C. The Company’s second product candidate, BLX-155, is
   a direct-acting thrombolytic, designed to break up blood clots in patients with diseases or
   conditions such as acute peripheral arterial disease, deep vein thrombosis and hemodialysis
   graft thrombosis. In addition, the unique capabilities of the LEX System have led to
   collaborations with Centocor, Medarex, Genmab and other leading pharmaceutical and
   biotech companies. Biolex is a venture-capital-backed company located in the Research
   Triangle region of North Carolina, United States. For additional information, please visit
   Biolex’s web site at www.biolex.com.
   ###
   Contacts:
   Media: Miche
2. [verwijderd] 16 juli 2007 12:18

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   we hebben vandaag nog geen euro omzet....gaat lekker zo.....
3. [verwijderd] 16 juli 2007 13:17

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   Het voordeel is, dat we dan ook niet zakken!
   
4. [verwijderd] 17 juli 2007 22:31

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   Wel raar dat de Hoekman hier zijn eigen stukken aan het verkopen is .
   
   Zal wel te maken hebben dat Duitsland lager
   staat .
   
   aktien.wallstreet-online.de/477692.html
   
   Lijkt ook wel of daar niet gehandeld wordt .Zie volume 0
   
   Weet iemand , hoe dat een beetje dat werkt .
   
   Bv Dank
   
   Gr zenzoe
5. [verwijderd] 23 juli 2007 17:40

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   misschiens weten ze meer al ons?
   weet wel dat wederom de beurs omhoog is gegaan en dat octo naar beneden is gegaan