To: Ploni who wrote (21417 ) 9/22/2006 5:21:21 PM From: keokalani'nui Read Replies (1) | Respond to of 52153 >>I also worry when I see a drug start out in one firm (AnorMED) and then be licensed to another; that makes me wonder if AnorMED had some data suggesting it wouldn't be a valuable drug, or if AnorMED just decided they wanted to concentrate on other projects.<< Then you probably would not feel real good about Astra returning it to aom in 2001?However, on August 31, 2001, we announced that AstraZeneca would be re-assessing their Phase III clinical trial program for NX473 based on updated clinical data in the Phase II ovarian cancer study. This data, which was presented at the European Conference of Clinical Oncology (“ECCO”) in October 2001, showed a decreased and disappointing response rate in resistant ovarian patients from the previously reported 2/14 (14%) to 3/42 (7%). Updated data in sensitive ovarian patients remains encouraging with a response rate of 12/31 (39%) compared to the preliminary data of 5/12 (42%). Additional NX473 data were also presented at ECCO demonstrating encouraging anti-tumor activity including confirmed responses with mono and combination therapy in a number of other tumors including pancreatic cancer and hormone resistant prostate cancer, among others. The data also confirmed that NX473 has a manageable toxicity profile and it has not been associated with clinically significant neuro- or nephrotoxicity. On November 26, 2001, we announced that AstraZeneca would not continue to develop NX473 and would return all commercial development rights to AnorMED. This decision was primarily based on the updated response rate in resistant ovarian cancer patients. Regardless of the promising response rate in second line platinum sensitive ovarian patients, activity in a variety of tumor types and manageable safety profile, NX473 did not meet the differentiated profile required by AstraZeneca, particularly in overcoming platinum resistance in ovarian and lung cancer patients who have previously failed a platinum based therapy. Upon return of NX473 to AnorMED, ongoing clinical studies in hormone resistant prostate cancer and bladder cancer continued with recruitment/follow-up in accordance with the existing protocols. These trials were prepaid by AstraZeneca and have completed enrollment. In order to evaluate further development options for NX473, we held a clinical advisory board meeting on January 2002 and also commissioned market analyses. Based on all available clinical data from over 500 patients and a solid safety profile, in conjunction with the clinical advisory board recommendations and the market analyses, we believe NX473 as a new platinum based chemotherapy has a broad spectrum of anti-tumor activity and may address an unmet medical need particularly in tumor types where existing platinums have shown limited activity such as hormone resistant prostate cancer (HRPC), among others. We have completed studies to support the potential of NX473 as an oral chemotherapy for use in combination with other oral chemotherapies or in conjunction with radiation therapy. In April 2004, we were successful in licensing NX473 to NeoRx Corporation.....