Altor BioScience Advances Clinical Trial for Targeted Cancer Therapeutic, ALT-801
- Category: Proteins and Peptides
- Published on Friday, 21 December 2007 10:46
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Altor BioScience Corporation today announced it has completed treatment of the first cohort of metastatic cancer patients in a Phase I/IIa clinical trial with the Company's lead drug candidate, ALT-801
MIRAMAR, FL, USA | December 20, 2007 | Altor BioScience Corporation today announced it has completed treatment of the first cohort of metastatic cancer patients in a Phase I/IIa clinical trial with the Company's lead drug candidate, ALT-801. Altor also reported that the expansion phase of this clinical trial will be supported in part through funding awarded by the U.S. Food and Drug Administration (FDA) Orphan Products Development (OPD) Grant Program. ALT-801 is a novel tumor-targeted immunotherapeutic designed to improve on the efficacy and safety of the FDA-approved anticancer cytokine, interleukin-2 (IL-2).
The open-label dose escalation trial in patients with progressive metastatic malignancies is currently ongoing at the H. Lee Moffitt Cancer Center, Tampa, FL, and at the M.D. Anderson Cancer Center, Orlando, FL. The primary objectives of the study are to evaluate the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic profile of ALT-801. The secondary objectives are to evaluate the immunogenicity and assess the antitumor response. Following MTD determination, the trial will be expanded to treat additional patients for further assessment of ALT-801’s safety and antitumor activity. To date, no dose-limiting toxicities have been observed in patients who have completed the multidose treatment course at the first dose level. Preliminary results also indicate that ALT-801 is biologically active at this dose level in patients. Patient screening for enrollment at the next dose level is underway.
Hing Wong, Ph.D, Altor's President & CEO, commented, "Having renowned cancer research centers conducting this study combined with the FDA grant validates the strong interest in this product candidate and therapeutic approach. I'm very pleased with the progress we have made with ALT-801 and with the encouraging results we’ve seen at this early stage of the trial."
The FDA-ODP grant was awarded to Mayer Fishman, M.D., Ph.D., a Principal Investigator at the H. Lee Moffitt Cancer Center, to support treatment of patients with metastatic melanoma and renal cell carcinoma during the Phase IIa expansion. The ODP Grant Program funds clinical product development for orphan diseases, including many cancer indications. Forty previous ODP-sponsored products have advanced to marketing approval.
ALT-801 is composed of IL-2 genetically fused to a soluble T-cell receptor (TCR) directed against a p53-derived tumor-associated antigen. Altor’s approach uses the TCR to guide IL-2 bioactivity to the tumor site, where the cytokine-stimulated immune system attacks the cancerous cells. Altor has found in preclinical testing that tumor-targeted delivery of IL-2 resulted in better efficacy and less toxicity than was observed with standard IL-2 treatment. Altor’s preclinical studies on ALT-801 were funded by various grants from the National Institutes of Health. Additional information on the ALT-801 clinical trial (ID:NCT00496860) can be found at www.clinicaltrials.gov.
About Altor BioScience
Altor is a privately-held biotechnology company developing targeted immunotherapeutics for treating cancer, viral infections, and inflammatory diseases based on its proprietary, integrated technologies for creation of soluble TCRs. For more information, visit www.altorbioscience.com.
SOURCE: Altor BioScience Corporation