NEW YORK, Oct. 15 /PRNewswire/ — Antigenics Inc. (Nasdaq: AGEN) announced today that the U.S. Food and Drug Administration (FDA) has designated Oncophage(R), the company’s personalized cancer vaccine, a Fast Track Product for the treatment of renal cell carcinoma.
Under the FDA Modernization Act of 1997, designation as a Fast Track Product means FDA will take appropriate actions to expedite the development and review of an application for approval. Fast Track designation is granted to products determined by the agency to treat a serious or life-threatening condition and have the potential to address an unmet medical need. In the FDA’s letter to Antigenics, the agency stated that it is “designating as a Fast Track development program the investigation of Autologous Tumor-Derived gp96 Heat Shock Protein-Peptide Complex (HSPPC-96, Antigenics) for its superior effect on survival as an adjunct to surgical resection of renal cell carcinoma compared to no additional post-surgical treatment.”
Oncophage is the first personalized cancer vaccine to receive Fast Track designation. Antigenics received the designation in approximately half the time allotted by the FDA to make a determination.
“Receiving Fast Track designation is an important milestone for the development of Oncophage,” said Russell Herndon, COO of Antigenics. “Oncophage is one of the most unique cancer treatments currently under development, representing years of research, groundbreaking discoveries and clinical breakthroughs. Antigenics’ goal has always been to treat cancer while allowing patients to enjoy a good quality of life. We look forward to working with the FDA to continue the development of Oncophage and the eventual approval of this very promising therapy.”
Oncophage is a vaccine comprised of a specific class of proteins known as heat shock proteins. Heat shock proteins are isolated from each patient’s cancer and contain a unique profile of signals which are the cancer’s “DNA fingerprint.” These unique signals have the capacity to re-program the immune system to recognize, react against and eliminate cancer. Normal cells are unaffected. This precision makes Oncophage different from conventional cancer treatments that target cancer cells indiscriminately. Patients’ tumors are sent to an Antigenics facility where individualized vaccines are quickly produced by a standardized, cost-effective process. Clinical studies using Oncophage began in 1997. Antigenics is conducting a Phase III study in patients diagnosed with kidney cancer at over 100 leading cancer centers in the U.S. and Europe. Phase I/II and Phase II studies were also conducted in pancreatic, colorectal, stomach and kidney cancers as well as in melanoma and non-Hodgkin’s lymphoma. Investigators participating in the studies have reported that some patients with extensive metastatic disease treated with Oncophage have experienced complete clinical responses and partial remissions with a favorable safety profile and excellent quality of life. Ongoing studies evaluating Oncophage are designed to confirm these initial results in randomized, controlled settings.
Antigenics develops treatments for cancers, serious infections, and autoimmune and degenerative disorders that are designed to be safer and less toxic than current alternatives. The Company’s core expertise is in immunology, cancer and personalized medicine. Antigenics’ most advanced drugs in development include Oncophage(R), a personalized cancer vaccine in Phase III development; a liposomal treatment for lymphoma; and QS-21, a superior antibody adjuvant partnered with leading pharmaceutical companies in many advanced stage clinical programs. For more information about Antigenics visit http://www.antigenics.com.
This release may contain forward-looking statements based on current management expectations. Various factors could cause actual results to differ materially from those projected in forward-looking statements, including those predicting the timing of clinical trials, the efficacy of products or the availability of capital. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company’s expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. These factors are more fully discussed in the Company’s periodic filings with the Securities and Exchange Commission.
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