Antigenics Begins Phase 1 Trial of Aroplatin in Solid Tumors and B-Cell Lymphoma
Posted on: Tuesday, 25 October 2005, 09:01 CDT
Antigenics Inc. (NASDAQ: AGEN) today announced that it has initiated a multicenter Phase 1 clinical trial of Aroplatin(TM), an investigational liposomal formulation of a proprietary platinum chemotherapeutic. The dose-ranging study will evaluate the safety and pharmacokinetic profile of Aroplatin, which has been reformulated to enhance the drug's activation and stability.
"The launch of the Phase 1 trial of the new Aroplatin reflects Antigenics' growing presence in oncology as well as the continued strength and versatility of our pipeline," said Renu Gupta, MD, senior vice president of development for Antigenics. "In addition to improving convenience of use, the reformulation of Aroplatin is designed to potentially lead to an increase in its efficacy."
The primary objectives of the multicenter Phase 1 study are to establish the maximum tolerated dose for Aroplatin, and to determine the product's pharmacokinetics and overall safety profile. The protocol is designed to enroll about 16 to 28 patients with advanced solid malignancies or B-cell lymphoma. Based on safety assessment and data indicative of preliminary clinical activity, Antigenics expects to implement a clinical development plan to further investigate the use of Aroplatin in multiple cancers.
Aroplatin is a novel, third-generation liposome-encapsulated platinum compound developed for the treatment of cancer. It is designed to reduce certain types of toxicities typically associated with other platinum agents as well as to overcome drug resistance.
About Antigenics
Antigenics is working to develop patient-specific immunotherapeutics and revolutionary treatments for cancers and infectious diseases. The company's lead product candidate is Oncophage(R) (vitespen; formerly HSPPC-96), a late-stage, patient-specific cancer vaccine being evaluated in several indications, including renal cell carcinoma and metastatic melanoma. Antigenics' portfolio also includes AG-858 (HSPPC-70), a patient-specific cancer vaccine in Phase 2 development; two liposomal cancer treatments, Aroplatin and ATRA-IV; and AG-707, a Phase 1 genital herpes program. For more information, please visit www.antigenics.com.
This press release contains forward-looking statements, including statements regarding Antigenics' presence in oncology and the state of the company's pipeline; the ability of the reformulation to lead to an increase in the efficacy of Aroplatin; and the company's plans to investigate the use of Aroplatin in multiple cancers. These risks and uncertainties include, among others, that the Phase 1 trial of Aroplatin may indicate that it causes side effects or that it has limited clinical utility; even if the results from this trial are positive, significant additional trials, the outcome of which are uncertain, would be required before submitting an application for marketing approval; decisions by regulatory agencies; timing and results of preclinical studies; and the factors described under Factors That May Impact Future Results in the Management's Discussion and Analysis of Financial Condition and Results of Operations section of Antigenics' Form 10-Q as filed with the Securities and Exchange Commission on August 9, 2005. Antigenics cautions investors not to place considerable reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this document, and Antigenics undertakes no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Antigenics' business is subject to substantial risks and uncertainties, including those identified above. When evaluating Antigenics' business and securities, investors should give careful consideration to these risks and uncertainties.
Source: Business Wire
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