Clinical Trials Roundup—Week of 11/30

Immune Response Announces Results From Rheumatoid Arthritis Trial

The Immune Response Corp. has published the results from a Phase II double-blind, placebo-controlled trial using the Company's IR501 therapeutic vaccine. The immune-based, T cell receptor (TCR) peptide therapy was used to treat 99 patients with active rheumatoid arthritis.

The trial results suggest that patients receiving intramuscular injections of IR501 combined with Incomplete Freund's Adjuvant (IFA) showed statistically significant improvement when compared with patients receiving only IFA.

For more information: Immune Response Corp., 5935 Darwin Court, Carlsbad, CA 92008, USA. Telephone: 619-431-8636.

AVI Biopharma Satisfied With Avicine Trial Results

AVI Biopharma, Inc. has completed Phase Ib/II clinical trials of Avicine, a therapeutic cancer vaccine, in patients with pancreatic cancer. Both the Phase Ib study conducted by Dr. Pierre Triozzi at Ohio State University and a pilot Phase II study conducted by the Company, showed evidence that Avicine is a safe and well-tolerated drug, with no observation of drug-related adverse effects.

Avicine elicits a highly specific immune response to the human hormone and growth factor hCG, a cancer-associated oncofetal protein.

For more information: Dr. Denis R. Burger, president and CEO, AVI Biopharma, Inc., telephone: 503-227-0554.

Transkaryotic Therapies Initiates Hemophilia Treatment Trial

Transkaryotic Therapies, Inc. has begun an initial clinical trial evaluating its non-viral gene therapy treatment for Hemophilia. Twelve patients with Hemophilia A will be enrolled in the Phase I safety study of Transkaryotic therapy, which will be conducted at the Beth Israel Deaconess Medical Center.

In Transkaryotic therapy, cells obtained from an outpatient skin biopsy are isolated and the gene of therapeutic interest is introduced into the cells. The genetically engineered cells are propagated and characterized and then returned to the physician for injection.

For more information: Transkaryotic Therapies, Inc., 195 Albany Street, Cambridge, MA 02139, USA. Telephone: 617-349-0200. Fax: 617-491-7903.

Studies Show Neurotin Reduces Chronic Neuropathic Pain

Two new studies reported in the Journal of the American Medical Association have shown that Neurotin (gabapentin capsules) can significantly reduce chronic neuropathic pain. One study examined the effects of Neurontin on patients with diabetic peripheral neuropathy (DPN). A companion study examined the use of Neurontin in patients suffering from post-herpetic neuralgia (PHN), the chronic neuropathic pain condition that can follow shingles (herpes zoster).

Neurontin, marketed by Parke-Davis as 100 mg, 300 mg and 400 mg capsules, is indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults.

For more information: Warner-Lambert Co., 201 Tabor Rd., Morris Plains, NJ 07950.

Cytokine Increases Cell Recruitment In Wound Healing

Cistron Biotechnology, Inc. has reported the results of a preclinical animal study of surgical wounds which indicated that IL-1 beta (IL-lb) increased cell recruitment, tissue growth, and production of key wound healing factors. The study concluded that IL-lb accelerated the deposition of collagen and prolonged the expression of the angiogenic (blood vessel growth) factor VEGF, as compared to the study's control group.

Interleukin-1B (IL-1B) is a primary cytokine that is able to localize and coordinate inflammatory processes. It is normally present in skin, and it is capable of modulating many of the cellular mechanisms necessary for wound healing.

For more information: Cistron Biotechnology, Inc., 10 Bloomfield Ave., Box 2004, Pine Brook, NJ 07058, USA. Telephone: 800-642-0167 or 973-575-1700. Fax: 973- 575-4854.

Impotence Treatment Proved Safe And Effective In China

NexMed, Inc.'s alprostadil (prostaglandin E1) cream was proven to be safe and effective for treating male erectile dysfunction (impotence) in a Phase III clinical trial conducted at three sites in China. A total of 143 impotent men were evaluated in double-blind and open label trials at the three sites. Of the 143 men, 54 were categorized as severely impotent and 89 as mildly to moderately impotent. The total overall efficacy rate for the combined trials was 75%.

For more information: Vivian Liu, NexMed, Inc., telephone: 609-208-9688, ext. 101.

MGI Pharma Begins Patient Enrollment In Ovarian Cancer Therapy Trials

MGI Pharma, Inc. has begun enrolling patients in a phase II clinical study with MGI 114, the company's anti-cancer drug, to evaluate the drug's ability to treat ovarian cancer. The patients for this study are women with advanced ovarian cancer who did not respond or are no longer responding to a chemotherapy regimen that includes paclitaxel (Taxol) and platinum-based agents.

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.

For more information: MGI Pharma, Inc., 9900 Bren Road East, Suite 300E, Opus Center, Minnetonka, MN 55343-9667, USA. Telephone: 612-935-7335. Fax: 612-935-0468.

Allelix Compound Increases BMD And BMC in Postmenopausal Osteoporosis Patients

Allelix Biopharmaceuticals has announced the results of a Phase II clinical trial demonstrating that its compound ALX1-11 significantly increases bone mineral density (BMD) and bone mineral content (BMC) in the spine of women with postmenopausal osteoporosis. The Phase II trial was conducted in 18 centers in the United States and Canada and involved 217 women with postmenopausal osteoporosis.

ALX1-11 is a proprietary recombinant version of human PTH and is identical to the naturally occurring protein produced by the parathyroid gland.

For more information: Allelix Biopharmaceuticals Inc., 6850 Goreway Drive, Mississauga, Ontario, L4V 1V7, Canada. Telephone: 905-677-0831. Fax: 905-677-9595.

Signal Completes Preclinical Studies Of Designer Estrogens

Signal Pharmaceuticals has successfully completed preclinical studies demonstrating the ability of two series of compounds to safely inhibit bone resorption in animal models of osteoporosis. The drug leads belong to a new class of small molecule compounds termed selective estrogen receptor modulators (SERMs), also referred to as 'designer estrogens.'

SERMs are designed to mimic the positive effects of estrogen by inhibiting bone loss in postmenopausal women, while avoiding some of estrogen's adverse effects such as increased risk of breast and uterine cancer.

For more information: Signal Pharmaceuticals, Inc., 5555 Oberlin Dr., San Diego, CA 92121, USA. Telephone: 619-558-7500. Fax: 619-558-7513.