Clinical Trials Roundup—Week of 12/7
Thalidomide Reduces Tumor Burden In Multiple Myeloma Trials
Researchers investigating thalidomide in the treatment of multiple myeloma have reported that 34% of patients undergoing therapy at the Arkansas Cancer Research Center experienced a reduction in tumor burden.
While researchers have not identified the mechanism by which thalidomide treats multiple myeloma, they suspect several possibilities, including the possibility that thalidomide suppresses tumor necrosis factor-a production, and that it increases the body's production of interleukin 10. Thalidomide may also work through anti-angiogenesis, by preventing the growth of vessels that aliment the malignant cells.
Immunex Corp. Demonstrates Tumor Rejection In Mice With Investigational Molecules
Scientists from Immunex Corp. have shown that mice treated with a combination of two investigational molecules, Mobist (Flt3 ligand) and CD40 ligand (CD40L), demonstrate a higher rate of tumor rejection than either molecule alone. Flt3 ligand is a cytokine that helps increase the number of certain blood cells including stem cells, progenitor cells and dendritic cells. CD40L is a protein primarily expressed on the surface of activated T cells. Its receptor, CD40, is expressed on B cells, dendritic cells and macrophages and plays a key role in activating the immune system.
The anti-tumor response was most likely caused by the generation of dendritic cells by Mobist and the activation of these cells by CD40L, the scientists say.
For more information: Tim Warner, manager of Corporate Communications, Immunex Corp., telephone: 206-470-4193.
Myelos Neurosciences Initiates Prosaptide TX14(A) Trial
Myelos Neurosciences Corp. has initiated a Phase II trial of the company's lead compound, Prosaptide TX14(A). The compound is designed to treat pain syndromes and a broad range of peripheral neuropathies, including those associated with diabetes, chemotherapy, and nerve injury.
In laboratory animals, Prosaptide TX14(A) has been demonstrated to induce neuronal regeneration, prevent neuronal death, alleviate peripheral neuropathy, and relieve neuropathic pain.
For more information: Melanie Marks, Myelos Neurosciences, telephone: 619-657-1040.
PowderJect Vaccine Seroconverts Patients' Antibody Levels
PowderJect Pharmaceuticals PLC and PowderJect Vaccines, Inc. have announced the results of a Phase Ib human clinical trial of their Hepatitis B prophylactic DNA vaccine. Interim analysis showed that all 11 subjects who have completed the vaccination schedule thus far, seroconverted to antibody levels that are accepted as conferring protection against Hepatitis B disease. Achievement of this clinical result triggers a $1 million milestone payment to PowderJect from Glaxo Wellcome under the collaboration agreement between the parties signed in March 1998.
For more information: PowderJect Vaccines, Inc., 585 Science Drive, Madison, WI 53711, USA. Telephone: 608-231-3150. Fax: 608-231-6990.
MGI Pharma Expands Prostate Cancer Study
MGI Pharma, Inc. is expanding its exploratory prostate cancer phase II study with MGI 114, the company's novel anti-cancer drug, to include an additional 16 evaluable patients. The decision to expand the trial was made after the minimum response criteria for expansion were observed in patients in the trial.
MGI 114 is the lead compound of a family of cytotoxic agents, called the acylfulvenes, that appear to have several potential advantages over existing therapies. These include a unique mechanism of action; activity against tumor cell lines that are resistant to standard antitumor therapies; and a synergistic effect against tumor cells when combined with certain approved drugs.
For more information: MGI Pharma, Inc., Suite 300E, Opus Center, 9900 Bren Road East, Minneapolis, MN 55343, USA. Telephone: 612-935-7335.
Targeted Genetics Initiates Phase I Trial
Targeted Genetics Corp. has initiated a Phase I clinical trial for an aerosolized version of the company's proprietary gene therapy product for the treatment of cystic fibrosis (CF), tgAAV-CF. The multi-center, dose-escalation, open-label study will evaluate the safety of tgAAV-CF in up to 12 adult patients with mild to moderate CF lung disease.
Targeted Genetics believes that an aerosolized formulation will provide widespread delivery of tgAAV-CF to the airways of the human lung and has the potential to alleviate the pulmonary symptoms associated with CF.
For more information: Targeted Genetics Corp., 1100 Olive Way, Suite 100, Seattle, WA 98101, USA. Telephone: 206-521-7824. Fax: 206-521-7872.
AVI BioPharma Releases Data From Phase II Avicine Trial
AVI BioPharma, Inc. has released clinical data from a multi-center Phase II clinical trial of Avicine, its therapeutic cancer vaccine, in advanced colorectal cancer. The data reflects a two-year clinical trial in which two doses of Avicine were compared in 77 patients with measurable metastatic colorectal cancer. Overall, patient data demonstrates a measurable immune response to human chorionic gonadotropin (hCG), increased survival in immune responders, and from a safety standpoint, essentially no toxicity.
For more information: Dr. Denis R. Burger, president and CEO, AVI BioPharma Inc., telephone: 503-227-0554.
Results From Xenotransplantation Toleragen Trials Prove Positive
La Jolla Pharmaceutical Co. has announced positive results from the testing in primates of a new xenotransplantation Toleragen candidate, LJP 920. Data indicate that LJP 920 was well tolerated and, on a short-term basis, reduced levels of antibodies involved in organ rejection.
La Jolla's Toleragen molecules are designed to inactivate specific immune system B cells that produce destructive antibodies without affecting the protective functions of the recipient's immune system. The xenotransplantation Toleragen is based on the Company's proprietary Tolerance Technology.
For more information: La Jolla Pharmaceutical Co., 6455 Nancy Ridge Drive, San Diego, CA 92121, USA. Telephone: 619-452-6600. Fax: 619-452-6893.
Seattle Genetics, Inc. Initiates Immunotoxin Trial
Seattle Genetics, Inc. has begun a Phase I clinical trial using the single-chain immunotoxin SGN-10 (BR96 sFv-PE40) in patients with carcinoma. The study is being performed at the University of Alabama at Birmingham Cancer Center and at Fox Chase Cancer Center in Philadelphia, PA.
Immunotoxins bear an antibody-binding site specific for tumor cells and a toxin that enzymatically blocks protein synthesis. Their mechanism of action is different from that of conventional chemotherapeutics.
For more information: H. Perry Fell, Seattle Genetics, Inc., telephone: 425-489-4990.