Clinical Trials Roundup—Week of 6/14
Vion's VNP20009 Inhibits Tumor Growth in Mice
Additional data of VNP20009, Vion Pharmaceuticals Inc.'s (New Haven, CT) first Tapet bacterial candidate, suggest that, following direct intratumoral injections in mice, VNP20009 is capable of migrating from injected tumors to distal non-injected tumors. Preclinical studies also demonstrate in animals that direct intratumoral administration of VNP20009 inhibited the growth of injected tumors, uninjected tumors, and lung metastases.
VNP20009 bacteria are unarmed Tapet vectors developed for Phase I clinical safety studies. Tapet (Tumor Amplified Protein Expression Therapy) uses bioengineered bacterial vectors that exhibit increased replication in solid tumors in preclinical tests. These Tapet vectors, based on highly attenuated Salmonella bacteria, have been engineered to thrive and multiply within the confines of a tumor.
For more information: Alan Kessman, CEO, Vion Pharmaceuticals Inc., 4 Science Park, New Haven, CT 06511. Tel: 203-498-4210. Fax: 203-498-4211.
Techniclone Begins Dosing In Cotara Phase I/II Trial
Techniclone Corp. (Tustin, CA) has begun treating its first two prostate cancer patients in its Phase I/II trial using Cotara for the treatment of pancreatic, prostate, and liver cancers. The study, held in Mexico City, will include approximately 18 patients with advanced prostate, pancreatic, and liver cancers, and will explore the benefits of alternative delivery procedures (which include intratumoral and intravenous injection).
Cotara, which binds to dead/decaying cells found in the core of solid tumors, is also presently in Phase II clinical trials in the US for malignant glioma (brain cancer).
For more information: Larry O. Bymaster, President and CEO, Techniclone Corp., 14282 Franklin Ave., Tustin, CA 92780-7017. Tel: 714-508-6000. Fax: 714-838-9433.
Avigen's AAV Vector Restores Dopamine Activity in Primate Model of Parkinson's
Research results of primate studies using Avigen Inc.'s (Alameda, CA) adeno associated virus (AAV) vector suggest that the drug has high potential for treating Parkinson's disease. The gene therapy technology can restore dopamine activity in a primate model of Parkinson's disease.
To date, the challenge in gene therapy has been identifying a mechanism by which genetic information can be successfully transferred to the appropriate cells to the body. Although viruses have been identified as possible delivery agents, many viruses are harmful or even deadly, and are effective only under certain carefully controlled conditions. Avigen's AAV vector system may be a potential solution to this challenge.
For more information: John Monahan, President and CEO, Avigen Inc., 1201 Harbor Bay Pkwy., Ste. 1000, Alameda, CA 94502. Tel: 510-748-7150. Fax: 510-748-7155.
Genentech, Alkermes Complete Successful Trial of GHD Drug
Genentech Inc. (South San Francisco, CA) and Alkermes Inc. (Cambridge, MA) have completed a Phase III multi-center trial of Nutropin Depot, the first long-acting form of recombinant growth hormone. The Phase III trial was designed to test the efficacy, safety, and tolerability of Nutropin Depot in the treatment of children with growth hormone deficiency (GHD) who had not received any previous treatment with growth hormone. Final results of the study demonstrated that Nutropin Depot increased growth rates in children with GHD.
Nutropin Depot is a long-acting formulation of Genentech's recombinant human growth hormone (rhGH) using Alkermes' ProLease injectable sustained-release drug delivery system. This new formulation was designed to reduce the frequency of injections by encapsulating the drug in biodegradable microspheres that, once injected, release rhGH slowly over a sustained period of time.
For more information: Arthur D. Levinson, President and CEO, Genentech Inc., One DNA Way, South San Francisco, CA 94080-4990. Tel: 650-225-1000. Fax: 650-225-6000.
Abgenix Completes Enrollment in Phase I/II Trial of Psoriasis Drug
Abgenix Inc. (Fremont, CA) has completed enrollment in its ongoing Phase I/II clinical trial of ABX-IL8 in psoriasis. The multi-center trial has enrolled 42 patients with moderate-to-severe psoriasis. The trial is placebo controlled and involves a multi-dose, dose-escalating cohort design.
ABX-IL8, a fully human antibody, is being studied in psoriasis because of its ability to block Interleukin-8 (IL-8). IL-8 is a cytokine that can cause unwanted inflammation by drawing immune cells into psoriatic tissue and activating them. IL-8 is also a growth factor for skin cells that proliferate in psoriatic tissue. IL-8 is also a potent angiogenesis factor that may contribute to the ingrowth of blood vessels that nourish psoriatic tissue.
For more information: R. Scott Greer, President and CEO, Abgenix Inc., 7601 Dumbarton Circle, Fremont, CA 94555. Tel: 510-608-6500. Fax: 510-608-6511.
Ligand's Targretin Reduces Breast Cancer Cell Growth in Rat Model
Results of Ligand Pharmaceuticals Inc.'s (San Diego) pre-clinical study show a novel molecular activity of Targretin (bexarotene), also known as LGD1069, in a rat breast cancer model. Targretin is a synthetic retinoid analogue that selectively activates a subclass of retinoid receptors called retinoid X receptors (RXR). These studies demonstrate that Targretin induces fat cell differentiation and reduces growth of cancer cells, resulting in regression of the tumors.
Previous studies have shown the efficacy of Targretin in preclinial models for breast cancer prevention and for the treatment of well-established breast tumors. Additional preclinical studies have shown that a combined therapy of Targretin and tamoxifen cause complete or partial regression in 94% of tamoxifen-resistant primary breast tumors.
For more information: David E. Robinson, President and CEO, Ligand Pharmaceuticals Inc., 10275 Science Center Dr., San Diego, CA 92121-1117. Tel: 619-550-7500. Fax: 619-550-7506.
Sensus Completes Successful Phase III Trial of Acromegaly Drug
Sensus Drug Development Corp. (Austin, TX) announced positive results in its Phase III clinical trial with its lead compound, pegvisomant (B2036-PEG), a novel growth hormone receptor antagonist. Pegvisomant demonstrated statistical significance in the reduction of IGF-I, its primary endpoint (p<.0001), and in the relief of clinical symptoms (p<.05) associated with acromegaly. These results were achieved across all three active dose groups.
Pegvisomant is a growth hormone receptor antagonist. The compound targets growth hormone receptors and binds with them to prevent circulating growth hormone from attaching to these sites. In doing so, pegvisomant ultimately blocks the action of growth hormone, as well as the consequent production of IGF-I, which is ultimately responsible for acromegaly.
For further information: John A. Scarlett, President and CEO, Sensus Drug Development Corp., 98 San Jacinto Blvd., Ste. 430, Austin, TX 78701. Tel: 512-487-2000. Fax: 512-487-2045.
Cantab Wraps up Phase I Trial of Anti-Cocaine Vaccine
Cantab Pharmaceuticals plc (Cambridge, UK) has completed a Phase I clinical trial with its anti-cocaine vaccine, TA-CD. The trial, designed to demonstrate the safety and immunogenicity of TA-CD, found that TA-CD: was safe and had no vaccine-associated adverse events, caused a dose-related antibody response in patients that lasted 84 days, and was capable of recognizing free cocaine in the blood.
A randomized placebo-controlled Phase II clinical trial is planned to commence in the second half of 1999. In addition to providing further information on product safety and immunogenicity, it will aim to evaluate the effect of TA-CD on reducing patient cocaine use.
For more information: Jurek Sikorski, CEO, Cantab Pharmaceuticals plc, 184 Cambridge Science Park, Milton Rd., Cambridge CB44GN, UK. Tel: +44-1223-423-413. Fax: +44-1223-423-458.
Novogen's NV-06 Shows Promise in Prostate Cancer Treatment
Results from ongoing studies with Novogen Ltd.'s (New South Wales, Australia) drug candidate NV-06 show that the drug has an inhibitory effect on the smooth muscle cells in the walls of blood vessels in the prostate. Smooth muscle cells are an important key to the development of prostate diseases, such as prostate enlargement (or BPH) and prostate cancer.
NV-06 is a synthetic form of a naturally-occurring human phenolic hormone that has demonstrated significant anti-cancer activity in the laboratory against a wide range of human cancer cells, including breast, prostate, large bowel, melanoma, and leukemia cancer cells.
For more information: Graham Kelly, Executive Chairman, Novogen Inc., 140 Wicks Rd., North Ryde, New South Wales 2113, Australia, Tel: +61-2-9878-0088. Fax: +61-2-9878-0055.
Novogen's Red Clover Product Decreases Hot Flashes in Menopausal Women
Promensil, Novogen's (New South Wales, Australia) herbal treatment derived from red clover, significantly reduces the number and intensity of hot flashes and night sweats occurring in menopausal women, according to a recent clinical study. In the study, 25 postmenopausal women (age 40–60) who suffered from hot flashes and other menopausal symptoms were treated with Promensil, a red clover derivative that is rich in isoflavones, which have estrogen-like biologic activities.
After eight weeks of taking the red clover supplement, the mean number of hot flashes decreased by 56%, from an average of 7.7 a day to 3.2 a day. In addition, patients indicated that the rate of intensity of hot flashes and night sweats, on a scale of 0 to 3, decreased from 1.9 to 1 and 1.8 to 0.7 respectively. The study indicated no adverse effects. Also, the uterine lining did not thicken as a result of taking red clover supplements.
For more information: Graham Kelly, Executive Chairman, Novogen Inc., 140 Wicks Rd., North Ryde, New South Wales 2113, Australia, Tel: +61-2-9878-0088. Fax: +61-2-9878-0055.
Novopharm Begins Phase I/II Trial of NovoVAC-M1 for Melanoma
Novopharm Biotech Inc. (Toronto) has commenced treating melanoma patients in a Phase I/II clinical trial of NovoVAC-M1, its fully human antibody vaccine. The purpose of the trial is to establish the safety of, and the specific immune response to, NovoVAC-M1. The study is currently accruing a minimum of 15 patients into three groups of five, each measuring the immune response to GD2 (a melanoma-associated antigen).
For more information: Anthony Schincariol, President and CEO, Novopharm Biotech Inc., 54 Novopharm Court, Scarborough, ON, M1B 2K9 Canada. Tel: 416-291-8876. Fax: 416-291-0608.