Clinical Trials Roundup—Week of 3/29
Biomira, Independent Panel Complete Phase I Evaluation of Cancer Vaccine
Biomira Inc. (Edmonton, AB, Canada) announced today the completion of its Phase I clinical trial with its synthetic BLP25 cancer vaccine in 14 evaluable patients with non-small cell lung cancer. Preliminary analysis of the data shows that BLP25 is both safe and triggers a cytotoxic T-lymphocyte immune response against cancer cells. An outside panel of oncology experts compared the clinical data from the Phase I testing of Biomira's two MUC-1 peptide cancer vaccines, BP16-KLH and BLP25, and agreed with the company that BLP25, a synthetic vaccine, should be developed further for the treatment of cancer. Biomira plans to conduct further testing in cancer patients to determine the optimal dosing for induction of an immune response to cancer.
BLP25 is a 25-amino acid sequence of the MUC-1 cancer mucin, encapsulated in a liposomal delivery system (a man-made phospholipid smaller than a red blood cell) to enhance recognition by the immune system. As a therapeutic vaccine, it is designed to induce an appropriate immune response to cancer cells. The vaccine is believed to have potential in the treatment of epithelial cancers such as cancers of the breast, lung and colon.
For more information: Alex McPherson, President and CEO, Biomira Inc., 2011 94th St., Edmonton, Alberta T6N 1H1, Canada. Tel: 403-450-3761. Fax: 403-463-0871. Email: amcpherson@biomira.com.
Aronex Begins Phase II Study of Platar
Aronex Pharmaceuticals Inc. (The Woodlands, TX) announced today the initiation of a Phase II clinical trial evaluating the use of Platar, a chemotherapeutic agent, in patients with metastatic renal cell carcinoma. This trial is funded by Aronex Pharmaceuticals and is being conducted by researchers at the University of Texas M.D. Anderson Cancer Center (Mdacc; Houston) under an Institutional Investigational New Drug application (IND).
Platar is a liposomal formulation of a novel platinum product designed to overcome the toxicity and drug resistance that currently limit the usefulness of platinum, a chemotherapeutic agent widely used in the treatment of solid tumors. In addition to the renal cell carcinoma indication, Platar is currently being evaluated at Mdacc under an Institutional IND in a Phase II clinical trial for the treatment of mesothelioma, a type of lung cancer. Aronex Pharmaceuticals is also evaluating the efficacy of Atragen (an injectable form of all-trans retinoic acid or tretinoin) in a Phase I/II clinical trial in patients with advanced renal cell carcinoma.
For more information: Geoffrey F. Cox, Chairman and CEO, Aronex Pharmaceuticals Inc., 8707 Technology Forest Place, The Woodlands, TX 77381-1191. Tel: 281-367-1666. Fax: 281-367-1676. Email: gcox@aronex-pharm.com.
BioChem Pharma Begins Phase II trials of Troxacitabine
BioChem Pharma Inc. (Quebec) has begun Phase II clinical trials of troxacitabine (formerly known as BCH-4556), a novel anticancer compound. The Phase II trial program is designed to evaluate the safety and efficacy of troxacitabine in the treatment of a variety of solid tumors (pancreas, prostate, breast, ovarian, colorectal, renal, non-small cell lung cancers, and melanoma) and in leukemia. The Phase II studies are planned to be conducted in approximately 40 hospital centres in North America and will involve about 250 patients. BioChem Pharma is conducting clinical trials of troxacitabine for CliniChem Development Inc. (Quebec), which was formed by BioChem in 1998 for the purpose of researching and developing certain therapeutic and vaccine products for human use.
Troxacitabine, discovered by BioChem Pharma, is the first dioxolane nucleoside analogue anticancer agent. Studies have shown troxacitabine to be a complete DNA chain terminator and DNA polymerase inhibitor. As such, it appears to incorporate itself into the growing DNA chain of cancer cells, interfering with their ability to replicate further. In addition, troxacitabine is not degraded by cytidine deaminase as is the case with other cytidine analogues used in cancer therapy.
For more information: Michele Roy, Corporate Communications, BioChem Pharma Inc., 275 Armand-Frappier Blvd., Laval, Quebec H7V 4A7, Canada. Tel: 514-978-7771. Fax: 514-978-7755. Email: corpcom@biochempharma.com
Inflazyme To Commence Phase I Clinical Trials with Potential Asthma Therapy
Inflazyme Pharmaceuticals Ltd. (Richmond, BC, Canada) has received a preliminary report from Inveresk Research (Tranent, Scotland) on 14-day pre-clinical toxicology testing of Inflazyme's IPL576,092. Based on a detailed analysis of the results obtained, Inveresk Research has advised that, subject to review and approval of Inflazyme's Phase I protocol by an ethics committee, the company may proceed with Phase I human clinical trials. Inflazyme plans to initiate these trials before the end of Q2, 1999.
IPL576,092 is being developed for the treatment of asthma. Inflazyme has demonstrated that IPL576,092 has a significant effect on mediators of inflammation in vitro and in standard pre-clinical in vivo studies of asthma when administered orally or by inhalation. These pre-clinical studies demonstrate that IPL576,092 may have the efficacy of inhaled glucocorticoids without the related side effects.
For more information: Ian McBeath, President and CEO, Inflazyme Pharmaceuticals Ltd., Suite 425, 5600 Parkwood Way, Richmond, British Columbia V6V 2M2, Canada. Tel: (604) 279-8511. Fax: 604-279-8711. Email: imcbe@inflazyme.com.
TGC Completes PhaseI/II Trial of Gene Therapy Product for Treatment of CF
Targeted Genetics Corp. (TGC; Seattle) recently announced findings from a Phase I/II clinical trial of tgAAV-CF, the company's proprietary gene therapy product for the treatment of cystic fibrosis (CF). In this blinded, placebo-controlled trial, conducted at Stanford University, 23 cystic fibrosis patients were treated with tgAAV-CF in one maxillary sinus and with placebo in the other. There were no adverse events related to the test agent. Results from the study indicate that inflammation was reduced in sinuses treated with tgAAV-CF and not in sinuses treated with placebo. Full results of the study are being prepared for scientific review and publication.
For more information: Darrell J. Salk, Vice President, Clinical Affairs, Targeted Genetics Corp., 1100 Olive Way, Ste. 100, Seattle, WA 98101. Tel: 206-623-7612. Fax: 206-223-0288. Email: salk@targen.com.
Georgetown University Begins Study Of STGI's Anticort
Steroidogenesis Inhibitors International (STGI; Las Vegas) reported that Georgetown University has begun a study using Anticort, an anticortisol/steroidogenesis inhibitor drug, in an attempt to prevent retinitis pigmentosa in transgenic mice. Results of the study, expected in less than six months, should provide potential clues for the prevention and eventual treatment of retinitis pigmentosa, a disease leading to blindness with no known treatment.
The use of Anticort is based upon its anticortisol activity, intended to protect against retinal degeneration from the potentially destructive effect of corticosteriods manufactured in the retina itself.
For more information: Janet Greeson, Steroidogenesis Inhibitors International, 2001 East Flamingo Blvd., Suite 100B, Las Vegas, NV 89119. Tel: 702-735-7001. Fax: 702-737-7016. Email: asapse@aol.com.
NCI Begins Phase II Pilot Trial Of Celgene's Thalomid
Celgene Corp. (Warren, NJ) announced the initiation of a Phase II pilot trial by the National Cancer Institute (NCI) to administer Thalomid (thalidomide) to patients with recurrent and metastatic squamous cell carcinoma of the head and neck. The trial is sponsored by the NCI's Cancer Therapy Evaluation Program (CTEP), and will be conducted at the University of Texas M. D. Anderson Cancer Center (Houston) under a Clinical Trials Agreement (CTA) between the NCI and Celgene. Researchers will collect primary data on evidence of disease stabilization and/or response in approximately 35 patients.
Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant, due to the high risk of severe birth defects or death to an unborn baby. Major adverse drug reactions associated with thalidomide treatment include: peripheral neuropathy (a common, potentially severe side effect that may be irreversible), drowsiness/somnolence, dizziness/orthostatic hypotension, neutropenia, and increased HIV-viral load.
For more information: John W. Jackson, Chairman and CEO, Celgene Corp., 7 Powder Horn Dr., Warren, NJ 07059. Tel: 732-271-1001. Fax: 732-271-4184. Email: jjackson@celgene.com.
Cytel Halts Clinical Trials of Cylexin
Cytel Corp. (San Diego) today announced that it has halted clinical trials with its lead therapeutic compound, Cylexin, based on disappointing results from its ongoing Phase II/III clinical trial. Cylexin showed no benefit over placebo in the 138-patient trial for the treatment of reperfusion injury in infants undergoing cardiopulmonary bypass to facilitate the surgical repair of life threatening heart defects. Based on these results, Cytel will end its pursuit of cell adhesion therapeutics.
For more information: Virgil Thompson, President and CEO, Cytel Corp., 3525 John Hopkins Ct., San Diego, CA 92121. Tel: 619-552-3000. Fax: 619-552-8801.
AMBI Releases Results of Chromax Clinical Trial
AMBI Inc. (Purchase, NY) announced the results of a clinical trial of its patented Chromax brand chromium picolinate. Cromax reduced or eliminated the symptoms of diabetes in 41 out of 44 patients with steroid-induced diabetes. The study was conducted by Alexander Ravina at the Diabetes Department of the Linn Clinic (Haifa, Israel) and was reported in the British Journal Diabetic Medicine.
In the study, patients took Chromax chromium picolinate and were then able to reduce or eliminate their diabetic medication, such as insulin; in addition, their blood sugar levels were lowered as well. These patients had developed diabetes as a result of undergoing steroid treatment for other diseases and had lost high levels of chromium. Patients were given Chromax chromium picolinate supplements beginning at 600 micrograms daily, gradually decreasing to 200–400 micrograms daily within one week. None of the patients treated experienced adverse side effects.
For more information: Fredric D. Price, President and CEO, AMBI Inc., 4 Manhattanville Rd., Purchase, NY 10577-2197. Tel: 914-701-4500. Fax: 914-696-0860. Email: FPrice@AMBIinc.com.
Results of Effexor XR Studies Presented at ADAA Meeting
Two new studies presented at the 19th Annual Meeting of the Anxiety Disorders Association of America (ADAA; Rockville, MD) demonstrate Effexor XR (venlafaxine HCl) Extended-Release Capsules to be an effective, long-term treatment for symptoms of GAD. In each of the two studies, which were funded by Wyeth-Ayerst Laboratories (Wayne, PA), patients given Effexor XR showed significant improvements in symptoms of GAD for up to six months, compared with those given a placebo.
The two randomized, double-blind, placebo-controlled trials evaluated the short- and long-term efficacy and safety of Effexor XR in treating symptoms of GAD. Patients treated with Effexor XR experienced significant reductions in symptoms of GAD, which were maintained for six months. Additionally, more patients treated with Effexor XR reported symptom improvement. The higher dose (150 and 225 mg) of Effexor XR also appeared to improve the ability of patients to adjust socially.
For more information: Wyeth-Ayerst Laboratories Inc., 555 E. Lancaster Ave., Wayne, PA 19087-5109. Tel: 610-688-4400. Fax: 610-995-4668.
Aquila Initiates Phase Iib Clinical Trial of Quilimmune-P
Aquila Biopharmaceuticals Inc. (Worcester, MA) has initiated a Phase IIb clinical trial of Quilimmune-P, a product designed to prevent pneumococcal infections in the elderly. The company has completed a Phase I trial in healthy volunteers and a Phase IIa study in the elderly. Results from the IIa study showed that Quilimmune-P was generally well tolerated but the differences between Quilimmune-P and the commercially available vaccine, in the frequency of a two fold or greater increase in antibody titer following a single immunization, were minor and not consistent.
Quilimmune-P is designed to enhance the immune response to Streptococcus pneumoniae, a prominent bacterial pathogen, and to provide improved protection in the elderly against diseases such as pneumonia, bacteremia, and meningitis.
For more information: Alison Taunton-Rigby, President and CEO, Aquila Biopharmaceuticals Inc., 365 Plantation St., Worcester, MA 01605. Tel: 508-766-2700. Fax: 508-766-2705. Email: ataunton@auilabio.com.