Health & Fitness
Health and Fitness
Health and Fitness
Tue, November 10, 2009
Mon, November 9, 2009
Fri, November 6, 2009 Agennix AG Shares Begin Trading on Frankfurt Stock Exchange
MARTINSRIED/MUNICH, GERMANY and PRINCETON, NJ and HOUSTON, TX--(Marketwire - November 6, 2009) - Agennix AG ( Financial update The Company reported that Agennix AG's cash and cash equivalents position (pro forma) at September 30, 2009 was EUR 17.9 million. The Company expects to have sufficient cash to fund operations into the second quarter of 2010. Agennix is considering different possible near-term financing options to further fund its ongoing clinical development efforts. The Company also announced that financial results for the third quarter of 2009 will be reported on November 23, 2009. Since the merger did not close until after the end of the third quarter, the results will be those of GPC Biotech only. The Company will also provide more detailed guidance for 2010 at that time. Development programs update Agennix also provided an update on its clinical development programs. Talactoferrin: Enrollment in the FORTIS-M Phase 3 trial is on track and will soon be expanded to Europe and the rest of the world. The FORTIS-M trial is a randomized, double-blind, placebo-controlled trial evaluating talactoferrin plus best supportive care versus placebo plus best supportive care in non-small cell lung cancer (NSCLC) patients whose disease has progressed after two or more prior treatment regimens. Enrollment in the FORTIS-C trial is ongoing at select sites in the U.S. The FORTIS-C trial is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating talactoferrin in combination with carboplatin and paclitaxel versus placebo in combination with carboplatin and paclitaxel as a first-line therapy in patients with locally advanced or metastatic NSCLC. Agennix has conducted two open label Phase 2 trials that evaluated talactoferrin as a monotherapy in renal cell carcinoma (RCC). The data from these trials suggest that talactoferrin has anti-cancer activity and is well tolerated in patients with RCC. Given that the standard of care has changed since these studies were conducted, the Company would anticipate continuing development in RCC in combination with other therapies rather than as a monotherapy. Therefore, Agennix is considering initiating a Phase 2b trial in combination with Sutent® (sunitinib) in patients with RCC. Data in the Phase 2 trial in severe sepsis is on target to be available at the end of the fourth quarter of 2009. RGB-286638: Dose escalation in the ongoing Phase 1 trial in solid tumors continues, with initial data expected in the second half of 2010. A Phase 1 trial in hematological tumors is expected to start in the first half of 2010 and will be conducted at the Dana-Farber Cancer Institute/Massachusetts General Hospital in Boston, MA, USA. Satraplatin: Discussions continue with the Company's partner for satraplatin in Japan, Yakult Honsha Co. Ltd., and other potential partners. Reminder: conference call scheduled Agennix AG will hold a conference call today, Friday, November 6, 2009 at 8 AM ET/14:00 CET to provide a business update. Participants may listen via live webcast, accessible through the Agennix Web site at [ www.agennix.com ], or via telephone. A replay will be available on the Web site following the live event. The call will be conducted in English. The dial-in numbers for the call are as follows: Please dial in 10 minutes before the beginning of the meeting. About Agennix AG Agennix AG is a publicly traded biopharmaceutical company focused on developing novel anti-cancer therapies. The Company was formed by the combination of GPC Biotech AG and Agennix Incorporated. The Company's most advanced program is talactoferrin, an oral targeted therapy that is in Phase 3 clinical trials in non-small cell lung cancer. Other clinical development programs include RGB-286638, a multi-targeted kinase inhibitor in Phase 1 testing; the oral platinum-based compound satraplatin; and a topical gel form of talactoferrin for wound healing. Agennix is a transatlantic company with sites in Munich, Germany; Princeton, New Jersey and Houston, Texas. For additional information, please visit the Agennix Web site at [ www.agennix.com ]. This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix AG. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future. Sutent® is a registered trademark of Pfizer Inc. Participants from Europe: 0049 (0) 69 667775756 0044 (0) 20 3003 2666 Participants from the U.S.: 1-646-843-4608
