CuraGen Corporation (Nasdaq: CRGN) and TopoTarget A/S (Copenhagen Stock Exchange: TOPO) announced nowadays the initiation of patient dosing during a part II clinical trial evaluating the activity of PXD101, alittle molecule histone deacetylase (HDAC) inhibitor, for the treatment of mesothelioma. This trial is being sponsored by the National Cancer Institute (NCI) underneath a Clinical Trials Agreement with CuraGen for the clinical development of PXD101.
The part II clinical trial is an open-label study being led by Suresh Ramalingam, M.D., Assistant Professor of medication at the University of Pittsburgh college of medication in Pittsburgh, PA. Patients with unresectable malignant pleural mesothelioma, who have failed one previous line of chemotherapy, are enrolled and receive PXD101 by intravenous infusion each 3 weeks. the first endpoint for the study is response rate, with secondary endpoints evaluating safety and measuring each the time to treatment failure and survival. a complete of roughly thirty seven patients are expected to be enrolled into this study at multiple sites across the u. s..
“A important quantity of preclinical analysis suggests that HDAC inhibitors, together with PXD101, alter the regulation of the many genes, leading to growth inhibition of human mesothelioma cells. Given the flexibility of HDAC inhibitors to down-regulate genes like BCL-XL and VEGF and up-regulate cell-cycle regulating genes, together with p21, we have a tendency to are excited to start evaluating PXD101 as a possible treatment for this sort of cancer,” stated Dr. Ramalingam. “There are not any proven treatment choices beyond the first-line chemotherapy regimen for mesothelioma, highlighting the importance of evaluating promising therapeutics like PXD101 for this patient population.”
Correlative pharmacodynamic studies will be conducted to judge the potential inhibition of HDACs in mesothelioma tumor cells from patients enrolled during this trial. analysis of the genes regulating proliferation and apoptosis (programmed cell death), similarly as acetylation of histone and non-histone proteins, are performed.
About Mesothelioma
As several as three,000 new cases of malignant mesothelioma are expected to be diagnosed within the u. s. in 2006. Mesothelioma may be a form of cancer arising from the cells, referred to as mesothelium, with the bulk of cancers starting within the chest cavity. The incidence of mesothelioma will increase with age and is never diagnosed in patients underneath fifty five years recent. though environmental exposure to bound chemicals and radiation are believed to play a job within the development of mesothelioma, exposure to asbestos is believed to be the most reason behind mesothelioma. The five-year survival rate for mesothelioma is approximately 100 percent, with a median survival of 1 to 2 years following diagnosis.
PXD101 may be a promising little molecule HDAC inhibitor being investigated for its role within the treatment of a large vary of solid and hematologic malignancies either as a single-agent, or together with alternative active anti-cancer agents, together with 5-fluorouracil (5-FU), carboplatin, paclitaxel and Velcade(R) (bortezomib) for Injection. HDAC inhibitors represent a brand new mechanistic category of anti-cancer therapeutics that concentrate on HDAC enzymes and are shown to: arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to beat drug resistance when employed in combination with alternative anti-cancer agents.
PXD101 is currently being evaluated in multiple clinical trials as a possible treatment for multiple myeloma, T-cell lymphoma, and colorectal and ovarian cancers, either alone or together with anti-cancer therapies. In August 2004, CuraGen signed a Clinical Trials Agreement with the NCI underneath that the NCI can sponsor many clinical trials to research PXD101 for the treatment of varied cancers, each as a single-agent and together chemotherapy regimens. In might 2005, TopoTarget announced the signing of a Cooperative analysis and Development Agreement (CRADA) with the NCI to conduct pre-clinical and non-clinical studies on PXD101 so as to higher perceive its anti-tumor activity and to produce supporting data for clinical trials.
About CuraGen
CuraGen Corporation (Nasdaq: CRGN) may be a biopharmaceutical company developing numerous approaches, together with novel protein, antibody, and little molecule therapeutics, that aim to supply hope for patients with cancer, inflammatory diseases, and diabetes. CuraGen’s strategic alliances have resulted during a deep pipeline of potential therapeutics that’s being developed by the Company’s experienced analysis and development groups. By leveraging the drug development strengths cultivated over the years, CuraGen expects to create a distinction within the lives of patients by bringing forward promising therapeutics that address unmet medical wants. To any exploit CuraGen’s intensive analysis and development experience, CuraGen founded a majority-owned subsidiary, 454 Life Sciences, that has developed and is commercializing advanced technologies for the sequencing of DNA. CuraGen and 454 Life Sciences are headquartered in Branford, Connecticut. for added data on the businesses please visit http://www.curagen.com and http://www.454lifesciences.com.
About TopoTarget
TopoTarget (CSE: TOPO) may be a totally integrated biopharmaceutical company, headquartered in Denmark and with subsidiaries within the UK and Germany, and dedicated to finding “Answers for Cancer” and developing improved cancer therapies. TopoTarget is founded and run by clinical cancer specialists and combines years of hands-on clinical expertise with in-depth understanding of the molecular mechanisms of cancer. Focus lies on key cancer enzyme regulators (mainly HDAC, mTOR, and topoisomerase II inhibitors) and a powerful development foundation of proprietary, highly predictive cancer models has been designed. TopoTarget encompasses a broad portfolio of little molecule preclinical drug candidates and eight medication are in clinical development, consisting of each novel anti-cancer therapeutics and new cancer indications for existing medication. the foremost advanced drug candidate, Savene(tm) for extravasations is anticipated on the market finish 2006. additionally to organic growth, TopoTarget consistently appearance for opportunities to strengthen and expand its activities through acquisitions and in-licensing. For a lot of data, please consult with http://www.topotarget.com.
Safe Harbor
This press unharness contains forward-looking statements together with statements concerning the expected effects and edges of PXD101. we have a tendency to caution investors that there is no assurance that actual results or business conditions won’t differ materially from those projected or prompt in such forward-looking statements as a results of numerous factors, including, however not restricted to, the following: the danger that anyone or a lot of of the PXD101 or the other CuraGen drug development program won’t proceed as planned for technical, scientific or industrial reasons or thanks to patient enrollment problems or primarily based on new data from nonclinical or clinical studies or from alternative sources; the success of competing product and technologies; technological uncertainty {and product|and merchandise|and product} development risks; uncertainty of further funding; CuraGen’s history of incurring losses and also the uncertainty of achieving profitability; CuraGen’s stage of development as a biopharmaceutical company; government regulation; patent infringement claims against CuraGen’s products, processes and technologies; the flexibility to shield CuraGen’s patents and proprietary rights; uncertainties regarding commercialization rights; and products liability exposure. Please consult with CuraGen’s Annual and Quarterly Reports on Forms 10-K and 10-Q for a whole description of those risks. CuraGen disclaims any intention or obligation to update or revise any forward-looking statements, whether or not as a results of new data, future events, or otherwise, unless needed by law.