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"Catherex’ oncolytic virus drugs tArgeting brAin, liver cAncers Philadelphia start-up Catherex Inc. is seeking to raise $5 million in a Series A financing to fund clinical trials of two candidate therapies for bladder and brain cancer, a pair of oncolytic virus assets that the company gained through a recent portfolio spin out from Germany’s MediGene AG. The founders of Catherex originated much of the technology behind the company’s pipeline of oncolytic herpes simplex virus (oHSV)-based therapies, in which the virus is used to potentially kill a significant portion of the tumor. Michael Christini, president and CEO of Catherex, noted that the team that worked on the technology has been together for a long time and has “first-hand experience” with the oncolytic virus approach.
The technology originally was developed by Bernard Roizman at the University of Chicago, and colleagues, who are now involved in the new venture. In addition to Christini and Roizman, the company’s founders include Richard Whitley, G. Yancey Gillespie and James Markert, all of the University of Alabama, Birmingham; Ralph Weichselbaum, of the University of Chicago; and Gabriella Campadella Fiume, of the University of Bologna, in Italy.
“We have a straight oncolytic virus,” Christini said of the two lead products, both of which are traditional oncolytic viruses. “They don’t express any genes” he said, rather they use virus replication to spread through and kill the tumor. Oncolytic viruses are engineered to selectively infect and kill tumor cells, while causing little if any damage to healthy tissues. MediGene gained ownership of the program via its purchase of NeuroVir Therapeutics Inc., of San Diego, a decade ago, in a stock-based deal then valued at $77 million. MediGene maintains a 40 percent ownerhip in Catherex. Drug candidate G207 has completed early stage clinical trials in glioblastoma, and NV1020 has undergone clinical studies as a treatment for liver metastases. Each of the two products has been safely administered to more than 40 patients. Catherex aims to move NV1020 into a Phase I/II trial in bladder cancer and to move G207 into a Phase II trial in brain cancer. A related product, M032, licensed from the University of Alabama, will also be studied in brain cancer initially and could offer greater potency than G207, as it expresses the human cytokine interleukin-12. There is a relatively crowded field of companies in the early stages of developing oncolytic viral cancer therapies. Among the companies that are further along in development is Biovex Inc., of Woburn, Mass., which has a Phase III candidate, OncoVex (Anm.von mir.. Inzw.bekanntl.für 1 Mrd.an Amgen verkauft), for metastasic melanoma. A Phase II study in squamous cell carcinoma of the head and neck was due to get under way in 2010. Crusade Laboratories Ltd., of Glasgow, Scotland, has a Phase II/III product candidate, Seprehvir, for glioblastoma that is similar to Catherex’s G207 candidate and Canada’s Oncolytics Biotech Inc. has Phase III study in head and neck cancer. Others developing oncolytic viral therapies include BioVex Inc., of Woburn, Mass., whose OncoVEX product is undergoing a Phase III 20 BioWorld’s innovations in Biotechnology 2011 trial in metastatic melanoma. A Phase II study in squamous cell carcinoma of the head and neck was due to get under way in 2010. Other players in the space include San Franciscobased Jennerex Inc., which uses a vaccinia virus strain to target tumors, and Wellstat Biologics Corp., of Gaithersburg, Md., which has Phase II oncolytic virus programs in colorectal and cervical cancer. In addition, there are numerous earlier stage academic programs focused on oncolytic virusbased cancer therapies. One of the potential advantages of oncolytic HSv therapy being developed by Catherex is that the treatment regimen developed by the company’s scientists involves precise and timely delivery of radiation and virus to achieve a synergistic effect and enhanced efficacy, according to the company. In addition, non viral genes such as cytokines can be stably incorporated into the viral genome to overcome the resistance of some tumors to oncolytic virus therapy. The company expects that its oncolytic HSV therapies could be administered repeatedly without impairing the efficacy of treatment. Catherex also expects that side effects will be significantly more benign than widely used cytotoxic chemotherapy products http://docslide.us/documents/bio-world.html |