this is the cost of zyc300 to mgi for 2006 so far.. as you can see i provided the link to the 2006 results for mgi..
ZYC300
License/milestone
2006 2005 2004
Other research and development
2,994 159 39
Total ZYC300
2,994 159 39
http://businessweek.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHTML1?SessionID=SzmvjTdF57RxvDb&ID=5003838
the link for the webcast tomorrow..
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=73842&eventID=1508488
Call Details
MGI PHARMA Earnings Conference Call (Q1 2007)
Scheduled to start Wed, Apr 18, 2007, 5:00 pm Eastern
Check back at the scheduled start time for
the audio link to appear in this spot.
Add This Event To Your Yahoo! Calendar
After the event has finished, the audio will be available
from this page until Thu, Apr 26, 2007
About MGI PHARMA (NasdaqGS:MOGN)
MGI PHARMA, INC., a biopharmaceutical company, engages in the discovery, acquisition, development, and commercialization of proprietary pharmaceutical products in the areas of oncology and acute care in the United States. Its products include Aloxi injection for the prevention of chemotherapy-induced nausea and vomiting (CINV); Dacogen for Injection, for the treatment of patients with myelodysplastic syndrome; Gliadel Wafer for the treatment of malignant glioma, and recurrent glioblastoma multiforme; Salagen Tablets, a treatment for the symptoms of xerostomia induced by radiation therapy in head and neck cancer patients; and Hexalen capsules for the treatment of ovarian cancer. The companys products in various phases of clinical trials comprise Aquavan Injection for sedation of patients undergoing diagnostic or surgical procedures; Aloxi Injection for the prevention of post operative nausea and vomiting; Aloxi Oral Capsule Formulation for the prevention of CINV; Saforis Powder for oral suspension; Amolimogene bepiplasmid to enhance the natural immune response of a patient infected with human papillomavirus; ZYC300, an encapsulated plasmid; Irofulven for chemotherapy treatment of cancer; PARP inhibitor compounds; and glutamate carboxypeptidase II for the prevention and treatment of chemotherapy-induced neuropathy. MGI PHARMA markets its products through direct sales force in the United States and through alliances with other pharmaceutical or biotechnology companies internationally. The company was founded in 1979 as Molecular Genetics, Inc. and changed its name to MGI PHARMA, Inc. in 1990. MGI PHARMA is headquartered in Bloomington, Minnesota.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2006
Commission File No. 0-10736
MGI PHARMA, INC.
ZYC300
Our second immunotherapy compound in clinical development is ZYC300. ZYC300, an encapsulated plasmid encoding a commonly expressed tumor antigen, has completed a phase 1 / 2 trial in 17 patients with late stage metastatic hematological and solid tumors. The enzyme cytochrome P450 1B1 (CYP1B1), is encoded by the ZYC300 plasmid. Data from this trial were selected for oral presentation at the American Society of Clinical Oncology (ASCO) 2003 Annual Meeting and demonstrated that ZYC300 was well tolerated and biologically active. During 2006, we began a second clinical trial in patients with solid tumors to further assess the safety and efficacy of ZYC300. Enrollment in this study is expected to be completed in 2007.
The Immune System and ZYC300
Recent studies, in both human and animal systems, have provided compelling evidence that the immune system can be activated to specifically recognize human tumor cells and kill them. Most attention has focused on T cells as the principal cause of anti-tumor immunity especially in light of findings that tumor-derived proteins function as tumor-associated antigens (TAA) and targets for T cells. The demonstration that TAA-specific immune responses can lead to tumor regression has been borne out extensively in animal models and data from clinical trials suggest that this approach is safe, feasible, and potentially effective in humans. Until recently, clinical
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efforts have been somewhat limited, in part because most tumor antigens are restricted in expression to one or a few tumor types and to a fraction of subjects with these types of tumors. CYP1B1, the enzyme encoded in the ZYC300 plasmid, is widely expressed in human cancer but rarely in normal tissues. Administration of ZYC300 in preclinical studies resulted in anti-tumor T cell responses and results from preclinical toxicity studies warranted clinical development.
A phase 1 / 2 a clinical trial in 17 subjects with advanced malignancies who had failed prior cancer treatments was conducted to test the safety, bioactivity and clinical activity of ZYC300. Each patient was administered ZYC300 intramuscularly every other week for the target number of at least 6 but not more than 12 doses at a fixed dose level. From a safety perspective, ZYC300 was well tolerated. With the exception of a single subject who experienced abscesses at the injection site, no systemic or local toxicity was considered related to treatment with ZYC300, and only mild to moderate localized injection site reactions were observed. From a bioactivity perspective, despite their advanced cancer stage and history of prior chemotherapy treatment, many patients were determined to have an immune response to ZYC300. Increased levels of CYP1B1, or biologic responses, were observed in 46 percent of 13 patients who received more than six doses and in 80 percent of the five patients receiving twelve doses of ZYC300. Clinical activity was observed in three patients that had stable disease following their last dose of ZYC300; all other patients had progressive disease. Each of the three patients who had disease stabilization was an immune responder. Durable clinical response to subsequent chemotherapy was seen in all six patients who had demonstrated a biologic response to ZYC300, including one complete response that lasted more than twelve months. Only one of the eleven non-biologic responders benefited from subsequent chemotherapy. In summary, we believe that the data support proceeding with additional clinical development of ZYC300.
http://businessweek.brand.edgar-online.com/EFX_dll/EDGARpro.dll?FetchFilingHTML1?SessionID=SzmvjTdF57RxvDb&ID=5003838