Pulled this off the web in regard to the LLY P3 DAB IL-2 trials. With a total of 5-10K sufferers, I am having a hard time figuring out where the 50M market comes from? Any ideas? Do you know if LGND gets the psoriasis rights to the drug as well? That could be worth something.
With the current low stock price and the extra stock LGND will be paying for the ALRI call, I hate to see another 20M worth of dilution for a drug that may only be used by a few thousand people.
>>Phase III Trials of IL-2 Fusion Toxin, DAB389IL-2, for the Treatment of Cutaneous T- cell Lymphoma (CTCL) (including Mycosis Fungoides/Sezary Syndrome)
Two separate trials: for patients with recurrent or persistent cutaneous T-cell lymphoma
One for patients who require immediate systemic therapy; all patients receive the study drug.
One for patients who do not require immediate systemic therapy; two-thirds of the patients receive study drug; one-third receive placebo.
Treatment schedule: patients may receive one course of treatment (once a day for five days) every three weeks for approximately 6 months.
Location: conducted at 23 medical centers in the U.S.
Background: -CTCL is a malignant lymphoma of the skin characterized by redness, plaque formation, and tumors. Therapies have included topical agents (e.g., nitrogen mustard), photopheresis, psoralen phototherapy (PUVA), electron beam irradiation, alpha-interferon, single agent or combination chemotherapy. None of these treatments are consistently effedtive for this disease, and only select patients with early stage disease may be curable. In half of these cases, the malignant cells express the interleukin-2 receptor. DAB389IL-2, the study drug, study drug, consists of fragments of diphtheria toxin genetically fused to interleukin-2 (IL-2) which targets the interleukin-2 receptor present on disease-involved cells. These cells internalize the diphtheria toxin and subsequently die.
History: DAB389IL-2 has been studied in several hundred patients with a variety of malignant and immunologic disorders. A significant proportion of patients with CTCL experienced responses, including several complete remissions. Side effects, including fever, nausea, flu-like symptoms, and rash have been generally well tolerated and transient.
Eligibility: will be determined at each site. Patients must have biopsy documented CTCL which expresses the interleukin-2 receptor.
Sponsors: Seragen, Inc. of Hopkinton, Massachusetts and Eli Lilly and Company.
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Clinical Trial Sites for Phase III CTCL Studies of DAB389IL-2.
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Glen Bowen, M.D. University of Michigan
Dept. of Dermatology 1910 Taubman Center Ann Arbor MI 48109-0314
Study Coordinator: Sandy Neckel, R.N. 313-936-9133
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Madeleine Duvic, M.D. U-T MD Anderson
Department of Dermatology 6431 Fannin, Room M5B 1.184 Houston TX 77030
Study Coordinator: Kathleen Hannah, R.N. 713-792-2360, Ext. 192.
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David Fivenson, M.D. Henry Ford Hospital
Dept. of Dermatology 2799 W. Grand Blvd. Detroit MI 28202
Study Coordinator: Melinda Thornton 313-876-1856/7911
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Francine Foss, M.D. BU Medical Center Dept. of Hematology/Oncology
88 East Newton Street, Evans Bldg. 556 Boston MA 02118
Study Coordinator: Helen Dewey, R.N., M.S.N. 617-638-7540
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Arthur Frankel, M.D. Med. U of South Carolina
Hollings Cancer Center, Rm. 306 171 Ashley St. Charleston, SC 29425-2225
Study Coordinator: Stephanie Menkhaus, R.N. 803-792-0641
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L. Michael Glode, M.D. University of Colorado Health
Sciences Center PO Box B171 4200 East Ninth St. Denver CO 80262
Study Coordinator: Jan Ferguson 303-372-9118
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Michael Gordon, M.D. University Hospital
550 N. University Blvd., Room 1730 Indianapolis IN 46202-5265
Study Coordinator: Pat Guiney 317-274-0932
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Peter W. Heald, M.D. Yale University School of Medicine
15 York Street, P.O. Box 208059 New Haven, CT 06520-8059
Study Coordinator: Inger Christensen 203-785-6445
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Brian Jegasothy, M.D. University of Pittsburgh Medical
Center 200 Lothrop Street Pittsburgh, PA 15213
Study Coordinator: Sue McCann 412-648-8168
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Youn Kim, M.D. Stanford University Medical Center
Dermatology Clinic 900 Blake Wilbur Drive, Room W0069 Stanford CA 94305
Study Coordinator: Emily Lee 415-723-5841
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Elizabeth Knobler, M.D. Columbia-Presbyteria Dept. of Dermatology
Dana Atchley Pavilion 161 Fort Washington Ave., Room 750 New York NY 10032
Study Coordinator: George Nevrodis 212-305-8615
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Timothy Kuzel, M.D. Northwestern U Cancer Center Section of Hematology/Oncology
303 East Chicago Avenue Olson Pavillion, Rm 8-524 Chicago IL 60611-3008
Study Coordinator: Ellen Samuelson, R.N., M.S. 312-908-5400
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Ann G. Martin, M.D. Washington University-Dermatology
4570 Children's Place St. Louis MO 63110
Study Coordinator: Jackie Dudley, R.N. 314-362-9841
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Arturo Molina, M.D. City of Hope Nat'l. Medical Center
Dept. of Hematology & Bone Marrow Transplant 1500 E. Duarte Rd. Duarte CA 91010
Study Coordinator: Karen McCurdy, R.N. 818-359-8111 Ext. 4971
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Elise Olsen, M.D. Duke University Medical Center Division of Dermatology
PO Box 3294 Durham NC 27710
Study Coordinator: Janice Eyer, R.N., B.S.N. 919-684-6844
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Allan R. Oseroff, M.D. Roswell Park Cancer Institute
Elm & Carlton Streets Buffalo, NY 14263
Study Coordinator: Terri Reddington 716-845-4403
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Lauren Pinter-Brown, M.D. Olive View UCLA Med. Center
Dept. of Internal Medicine 14445 Olive View Drive Sylmar CA 91342
Study Coordinator: Jane Hobbs 310-794-6500
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Mansoor Saleh, M.D. University of Alabama at Birmingham
1824 Sixth Avenue South WTI 263, UAB Station Birmingham AL 35294-3300
Study Coordinator: Tami Steedly 205-934-6927
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Daniel Sauder, M.D. Sunnybrook Health Science Centre
A-3 Dermatology 2075 Bayview Avenue Toronto, Ontario M4N 3M5 Canada
Study Coordinator: Deborah Ellard 426-480-5823
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Stanford Steward, M.D. Director, Medical Oncology Vanderbilt University
22 Avenue South 1956 The Vanderbilt Clinic Nashville TN 37232-5536
Study Coordinator: Linda Jackson, R.N. 615-322-4967
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Eric Vonderheid, M.D. Hahnemann Dermatology M.S.
478 Broad and Vine St. Philadelphia PA 19102
Study Coordinator: Kathy Kerrigan Vonderheid 215-762-4350
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Gary Wood, M.D. VA Hospital, Dept. of Dermatology
11100 Euclid Ave. Cleveland OH 44106
Study Coordinator: Mary Ann Buchholz 216-844-7164
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PARTICIPANTS SOUGHT FOR NEW CANCER THERAPY
Hollings Cancer Center researchers are participating in two clinical trials of a new drug designed to treat cutaneous t-cell lymphoma (CTCL), which includes mycosis fungoides and sezary syndrome. The drug, IL-2 Fusion Toxin, is genetically engineered to target only cancer cells, not the healthy cells around them.
CTCL is an uncommon cancer of the lymph system which affects between 5,000-10,000 people in the United States. The disease causes disfiguring skin lesions and in later stages, it can enter the bloodstream and spread to other organs. The new study drug consists of a fragment of cell-killing diphtheria toxin fused to IL-2, a growth factor that the body normally produces. The single protein formed by the fusion is capable of binding to and subsequently killing cancer-causing cells.
Seragen, Inc., and Eli Lilly and Company are sponsoring the Phase III trials of the drug at 23 sites. Dr. Arthur Frankel is the primary investigator for the studies at the Hollings Cancer Center. For information, call (803) 792-4271.<< |
