Clinical Trials Roundup—Week of 6/28
Valentis Begins Phase II Trial of Interleukin-2 for Squamous Cell Carcinoma
Valentis Inc. (Burlingame, CA) has initiated a multi-center Phase II clinical trial of its Interleukin-2 (IL-2) gene therapy for the treatment of squamous cell carcinoma of the head and neck. The trial will evaluate the safety and efficacy of the IL-2 gene medicine compared to conventional therapy in approximately 80 patients who have failed first line chemotherapy.
The IL-2 gene medicine is comprised of a plasmid (a segment of DNA) encoding the human IL-2 gene and a proprietary cationic lipid gene delivery system that enhances uptake of the gene into the target cells after direct intratumoral injection. The product is designed to provide sustained, localized expression of the IL-2 protein and to promote a local and systemic immune response against the tumor. The use of a non-viral gene delivery systems is intended to enable repeated administration of genes in a safe and effective manner.
For more information: Benjamin F. McGraw III, President and CEO, Valentis Inc., 863-A Mitten Rd., Burlingame, CA 94010. Tel: 650-697-1900. Fax: 650-652-1990.
Neurocrine Reports Positive Results from Preclinical Trial of IL-4 Fusion Toxin
Neurocrine Biosciences Inc. (San Diego) reported that in preclinical models of Kaposi's sarcoma (KS), treatment with its IL-4 Fusion Toxin resulted in eradication of KS tumors and prevented disease-related symptoms, such as cachexia (weight loss) and lymphophenia. IL-4 Fusion Toxin was developed by scientists from the laboratory of molecular tumor biology of Center for Biologics Evaluation and Research (CBER) of the FDA in collaboration with scientists from the National Cancer Institute. Neurocrine Biosciences licensed the rights to IL-4 Fusion Toxin and is currently conducting Phase I/II clinical trials with the drug in the lead indication, glioblastoma (malignant brain tumors).
Preclinical data suggest that, when infused directly into the glioblastoma, IL-4 Fusion Toxin kills the tumor cells but not healthy cells. IL-4 Fusion Toxin is a protein in which a blood cell derived growth factor (IL-4) has been joined with a Pseudomonas exotoxin, a potent toxin that can destroy cancer cells. IL-4 has very high affinity for-IL-4 receptors, which are highly localized on malignant brain tumors, but not on normal brain cells. IL-4 binds tightly to the IL-4 receptors on the surface of the glioblastoma cells and delivers the exotoxin directly into the cell, resulting in cell death.
For more information: Gary A. Lyons, President and CEO, Neurocrine Biosciences Inc., 3050 Science Park Rd., San Diego, CA 92121. Tel: 619-658-7600. Fax: 619-658-7602.
Beta LT Phase I/II Trial Enrolls Three Post-Bone-Marrow-Transplant Patients
LifeTime Pharmaceuticals (Silver Spring, MD), Dovetail Technologies Inc. (College Park, MD), and the Jewish General Hospital (Montreal) have enrolled three post-bone marrow transplant patients in a Phase I/II clinical trial evaluating the anti-cancer and immune system boosting properties of Beta LT (beta-alethine) in patients with multiple myeloma. The full target dose was given to each of the enrolled patients without any adverse events or any side effects being reported by either patients or their physicians. The first myeloma patient treated has been receiving Beta LT for 9 weeks.
The clinical trial is designed to have the statistical power necessary to permit evaluation of potential effects of BetaLT on various immune parameters and on tumor size upon accrual and treatment of the full complement of patients (14–28). Beta-alethine is licensed to LifeTime Pharmaceuticals by Dovetail Technologies.
For more information: Floyd Taub, Chairman, Dovetail Technologies Inc., 387 Technology Dr., College Park, MD 20742-3371. Tel: 301-405-0608. Fax: 301-405-9187.
Specificity, Sensitivity of LeukoScan Confirmed in Phase II Trial
Immunomedics Inc. (Morris Plains, NJ) has released Phase III trial results of their study of LeukoScan in the detection of osteomyelitis (bone infection) in diabetic patients with foot ulcers. The study found that LeukoScan's performance was equivalent in specificity (true-negative rate) and superior in sensitivity (true-positive rate) to the currently used white blood cell (WBC) imaging test. The current test requires the patient's white blood cells being labeled outside of the body and reinjected back into the patient. LeukoScan also showed a significantly better specificity than bone scanning in this study.
LeukoScan consists of a vial of an antibody fragment against a surface marker of neutrophils (subset of white blood cells responding to acute infections) that can be labeled with the nuclear tracer, technetium-99m, in just five minutes.
For more information: Robert J. DeLuccia, President and CEO, Immunomedics Inc., 300 American Rd., Morris Plains, NJ 07950. Tel: 973-605-8200. Fax: 973-605-8282.
Amylin Initiates Phase II Trial of AC2993 for Type 2 Diabetes
Amylin Pharmaceuticals Inc. (San Diego) has initiated a Phase II, multiple-dose clinical study with its drug candidate, AC2993 (synthetic exendin-4) in people with type 2 diabetes. This single-blind, multiple-dose, placebo-controlled crossover clinical study, conducted in the United States, will include people who use diet and exercise to manage their diabetes, those who take oral hypoglycemic agents, and those who use insulin.
The study will focus on the safety and tolerability of AC2993 in the three groups, as well as the drug candidate's effect on plasma glucose. Additionally, the study is designed to examine the effect of AC2993 on insulin concentrations and other metabolic parameters.
For more information: Joseph C. Cook Jr., CEO Amylin Pharmaceuticals Inc., 9373 Towne Centre Dr., San Diego, CA 92121. Tel: 619-552-2200. Fax: 619-552-2212.
Ranolazine May Increase Exercise Time in Chronic Stable Angina Patients
Results from a Phase II clinical trial of CV Therapeutics Inc.'s (Palo Alto, CA) ranolazine will appear in the July 1, 1999 issue of The American Journal of Cardiology. The paper reports the results of a randomized, double-blind, placebo-controlled crossover study of three dose levels of immediate release ranolazine (ranolazine IR). The study demonstrated that ranolazine may increase exercise time in chronic stable angina patients, and clarifies divergent findings from earlier studies.
The study assessed the potential anti-anginal action of ranolazine IR using treadmill exercise testing, generally considered the standard method for evaluating anti-anginal treatments. The paper presents data which indicate that at peak ranolazine plasma concentrations, all ranolazine dosing regimens tested may increase the following treadmill exercise parameters in patients with angina: duration of exercise, time to onset of angina, and time to 1mm ST-segment depression.
For more information: Louis G. Lange, CEO, CV Therapeutics Inc., 3172 Porter Dr., Palo Alto, CA 94304. Tel: 650-812-0585. Fax: 650-858-0390.
Active Biotech to Initiate Phase I Trial of SAIK Compounds for MS
Active Biotech (Lund, Sweeden) has received permission from Lakemedelsverket (the Swedish Medical Products Agency) to initiate Phase I clinical trials of a compound from the SAIK-project in humans. SAIK is Active Biotech's term for a family of compounds for the regulation of the immune defense system. The SAIK compounds will be concentrated primarily on the treatment of multiple sclerosis (MS). The product will be orally active, as opposed to the daily injections that MS patients are currently treated with.
For more information: Sven Andreasson, CEO and President, Active Biotech AB, P.O. Box 724, SE-220 07 Lund, Sweden. Tel: +46 46-19-20-00. Fax: +46 46-19-20-50.
Trimeris Begins Patient Selection, Dosing in T1249-101 Phase I Trial
Patient selection and dosing have begun in Trimeris Inc.'s (Durham, NC) T1249-101 Phase I clinical trial for T1249, the second of a new class of anti-HIV drugs that block the entry of the virus into cells. This dose escalation trial is designed to assess the safety and pharmacokinetics of T1249.
Three different daily doses of T1249 will be administered as monotherapy for 14 days to HIV-infected adults by once- or twice-daily subcutaneous injection. T1249-101 will enroll up to 60 HIV-infected individuals at up to eight sites in the United States. At entry these patients will have received no other anti-HIV drugs for at least two weeks prior to entering the study.
For more information: Dani P. Bolognesi, CEO, Trimeris Inc., 4727 University Dr., Ste. 100, Durham, NC 27707. Tel: 919-419-6050. Fax: 919-419-1816.