CEP-7055 has broad anti-tumor activity - WHERE IS THE DRUG?

new_direction

http://temple.pure.elsevier.com/en/publications/cep7055(d9bfced5-c800-4a2a-a647-7bb5ddde06be).html
Back in 2003: 'Inhibition of the vascular endothelial growth factor VEGF-VEGF receptor (VEGF-R) kinase axes in the tumor angiogenic cascade is a promising therapeutic strategy in oncology... Orally administered CEP-7055 has entered Phase I clinical trials in cancer patients.'

Where are these results?

http://yadda.icm.edu.pl/yadda/element/bwmeta1.element.elsevier-02e6ec89-385e-30e8-aaa1-d36656baf98a/c/main.pdf
'Numerous strategies could be used to inhibit this lymphangiogenic signaling pathway (Table 1), including ...  blocking the tyrosine kinase activity of VEGFR-2 and VEGFR-3 using orally active small molecule inhibitors that enter the cell; small molecules inhibiting both VEGFR-2 and VEGFR-3 include BAY 43-9006 (Wilhelm et al., 2004), CEP-7055..'

http://investors.cephalon.com/phoenix.zhtml?c=81709&p=irol-newsArticle&ID=238699&highlight=

Cephalon and Sanofi-Synthelabo Form Partnership for Worldwide Development and Marketing of Novel Angiogenesis Inhibitors

West Chester, PA - December 20, 2001 - Cephalon, Inc. (Nasdaq: CEPH) and Sanofi-Synthélabo   (Paris Bourse: Sicovam code 12057) today announced an agreement to co-develop   and co-market angiogenesis inhibitors for oncology that are based upon Cephalon's   proprietary kinase inhibitor technology. The agreement covers a number of orally   active molecules that are potent inhibitors of angiogenesis, the process by   which the body not only produces healthy blood vessels, but also provides the   nutrients and oxygen that feed the development and spread of solid tumors, such   as breast and lung cancers. Cephalon and Sanofi-Synthélabo will collaborate on the development and   marketing of these angiogenesis inhibitors in the United States, Canada and   Mexico, and will share in profits generated from product sales. Sanofi-Synthélabo   will acquire exclusive marketing rights to these angiogenesis inhibitors in   Europe and the rest of the world; Cephalon retains such rights in Japan. The   agreement includes an upfront license fee, milestone payments and royalties   on potential product sales for Cephalon. Total payments for this collaboration   have not been disclosed; however, payments to Cephalon for the first drug in   development, CEP-7055, could reach $32 million. "We believe that CEP-7055 will be the first of hopefully several innovative   compounds that will come from this R&D collaboration," said Jeffry   Vaught, Ph.D., president of research and development at Cephalon. "CEP-7055   is a new generation oncology compound that holds promise due to its specificity   for inhibiting tumor growth without the widespread toxicity that accompanies   traditional chemotherapy." Four compounds in Cephalon's portfolio of selective   tyrosine kinase inhibitors have entered human testing. Cephalon's VEGF Platform   In solid tumors, the pathological process of angiogenesis is induced by a number   of factors, the primary of which is polypeptide vascular endothelial growth   factor (VEGF). Cephalon's VEGF kinase inhibitors have been shown in vivo to   slow the growth of certain tumors. Preclinical studies have demonstrated that   one of these compounds, CEP-7055, has broad anti-tumor activity. The efficacy   of CEP-7055 is mediated by inhibition of the growth of the endothelial cells   necessary for angiogenesis in cancerous tumors. CEP-7055 is now being evaluated   in Phase 1 clinical trials for its potential utility in a variety of solid tumors. Sanofi-Synthélabo   With sales in 2000 of EUR 6 billion and 29,000 employees in more than 100 countries,   Sanofi-Synthélabo ranks among the world's top 20 pharmaceutical companies.   Sanofi-Synthélabo is focused on a core group of four therapeutic areas:   cardiovascular disease/thrombosis, disorders of the central nervous system,   internal medicine and oncology. Cephalon, Inc.   Cephalon, Inc., headquartered in West Chester, Pennsylvania, is an international   biopharmaceutical company that discovers, develops and markets products to treat   sleep and neurological disorders, cancer and pain. The company currently markets   its three proprietary products in the United States and nine products internationally.   Cephalon develops innovative products for the treatment of neurological diseases   and cancers through identification of novel compounds that affect cell survival   and death. Copies of press releases and additional information about Cephalon   can be obtained by visiting the company's Web site at http://www.cephalon.com.  In addition to historical facts or statements of current condition, this press   release may contain forward-looking statements. Forward-looking statements provide   Cephalon's current expectations or forecasts of future events. These may include   statements regarding our ability to complete an offering of subordinated notes,   anticipated scientific progress on its research programs, development of potential   pharmaceutical products, interpretation of clinical results, prospects for regulatory   approval, manufacturing development and capabilities, market prospects for its   products, sales and earnings projections, and other statements regarding matters   that are not historical facts. You may identify some of these forward-looking   statements by the use of words in the statements such as "anticipate,"   "estimate," "expect," "project," "intend,"   "plan," "believe" or other words and terms of similar meaning.   Cephalon's performance and financial results could differ materially from those   reflected in these forward-looking statements due to general financial, economic,   regulatory and political conditions affecting the biotechnology and pharmaceutical   industries as well as more specific risks and uncertainties such as those set   forth below and in its reports on Form 8-K, 10-Q and 10-K filed with the U.S.   Securities and Exchange Commission. Given these risks and uncertainties, any   or all of these forward-looking statements may prove to be incorrect. Therefore,   you should not rely on any such factors or forward-looking statements. Furthermore,   Cephalon does not intend to update publicly any forward-looking statements,   except as required by law. The Private Securities Litigation Reform Act of 1995   permits this discussion.

Just one example of promising treatment - what has happened since the initial findings?

new_direction

http://mct.aacrjournals.org/content/5/7/1744.long
in 2006: ...show the efficacy, survival benefit, and tolerability of chronic administration of CEP-7055 in combination with cytotoxic chemotherapeutic agents used clinically for the treatment of these malignancies. These preclinical data lend support for consideration of the potential clinical evaluation of CEP-7055 in combination with standard-of-care therapies in patients with glioblastoma and metastatic  colorectal cancer.