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Antigenics, Inc. (NASDAQ: AGEN) today indicated that GlaxoSmithKline’s (GSK) Phase III malaria vaccine clinical trial, containing Antigenics’ QS-21 Stimulon® adjuvant, has enrolled more than 5,000 children to date and is expected to involve up to 16,
http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=10001
For the development of a vaccine to treat certain forms of leukemia and lymphoma
Antigenics (AGEN)Q3 2009 Earnings CallOctober 29, 2009 11:00 AM ETComplete
http://seekingalpha.com/article/169934-antigenics-q3-2009-earnings-call-transcript?source=feed
Antigenics will evaluate its options, including an appeal of this decision, after the CHMP has formally adopted an opinion at the November 2009 plenary meeting. The patient population for which approval is being sought represents a major unmet medical need.
http://www.biospace.com/news_story.aspx?StoryID=159859&full=1
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LEXINGTON, Mass., Nov 04, 2009 (BUSINESS WIRE) --
Antigenics, Inc. (NASDAQ: AGEN) today indicated that GlaxoSmithKline's (GSK) Phase III malaria vaccine clinical trial, containing Antigenics' QS-21 Stimulon(R) adjuvant, has enrolled more than 5,000 children to date and is expected to involve up to 16,000 children. The pivotal efficacy study of RTS,S, the world's most clinically advanced malaria vaccine, is ongoing in seven African countries.
The QS-21 adjuvant is a key component in several of GSK's prophylactic and therapeutic vaccines, including RTS,S. Under the terms of the license and supply agreements between the companies, Antigenics will receive payments from GSK contingent upon achievement of successful milestones and from royalties on net sales for a period of at least 10 years after the first commercial sale.
"QS-21 has emerged as an important component in 15 vaccine products being tested in clinical trials," said Garo H. Armen, PhD, chairman and CEO of Antigenics. "QS-21 could become a significant revenue source for Antigenics in the coming years."
Under current plans, the RTS,S vaccine candidate would be submitted to regulatory authorities in 2012 based on efficacy in children 5-17 months of age. Additional safety and immunogenicity data from the infant population will be submitted soon thereafter, followed by efficacy data for infants once available. Depending on the final clinical profile of the vaccine and the timetable of the regulatory review process, the first vaccine introduction could take place over the next three to five years.
The RTS,S vaccine primarily addresses the malaria crisis in Africa which kills more than 800,000 people every year, the majority of which are children under the age of five.
About QS-21 Stimulon Adjuvant
Antigenics' QS-21 Stimulon adjuvant is one of the most widely tested vaccine adjuvants under development. QS-21 has not only become a critical component in the development of preventative vaccine formulations across a wide variety of infectious diseases, but may also be essential in enabling a new generation of therapeutic vaccines to treat cancer, infectious diseases and degenerative disorders. QS-21 is currently being evaluated in approximately 20 vaccine indications, of which several are in late-stage clinical trials by Antigenics' licensees, including GlaxoSmithKline and JANSSEN Alzheimer Immunotherapy.
About Antigenics
Antigenics (NASDAQ: AGEN) is a biotechnology company working to develop treatments for cancers and infectious diseases. For more information, please visit www.antigenics.com.
This press release contains forward-looking statements, including statements about clinical development and regulatory timelines for QS-21, potential future milestone and royalty payments to Antigenics in connection with the development and commercialization of QS-21, and the significance of QS-21 as a component in products under development. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, Antigenics' dependence on its collaborative partners such as GSK to successfully develop and commercialize products containing QS-21, the scientific risk associated with the development of vaccines, the competitive risk that other sources of competitive adjuvants could become available, difficulties or delays in manufacturing QS-21, and the risk factors described in the Risk Factors Section of our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission for the period ended June 30, 2009. 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: Antigenics, Inc.
Antigenics, Inc. Media: Brad Miles, 212-477-9007 ext 17 or Investors: Shalini Sharp, 800-962-2436
Tags: africa biotechnology business cancer ceo children clinical commercial manufacturing nasdaq population products revenue securities trial vaccine
Companies: Antigenics, Inc. (AGEN), GlaxoSmithKline plc (GSK)
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Tags: market nasdaq profit securities trial
Companies: Antigenics, Inc. (AGEN)
Oct 29, 2009 (Wall Street Horizon via COMTEX) --
Antigenics, Inc. (AGEN)
Expected next earnings release: Announcement date: 10/29/2009 - Before Market Earnings Quarter: Q3 Announcement Status: Verified
Expected next investor conference call information: Conference Call Date: 10/29/2009 Conference Call Time (ET): 11:00 AM Conference Call URL: http://www.antigenics.com/investors/calendar/
Tags: conference corporate earnings market
Companies: Antigenics, Inc. (AGEN)
LONDON, Oct 21, 2009 (BUSINESS WIRE) --
Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), has verbally informed the Company at an oral meeting to anticipate a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) in early-stage, localized renal cell carcinoma (kidney cancer).
Antigenics will evaluate its options, including an appeal of this decision, after the CHMP has formally adopted an opinion at the November 2009 plenary meeting. The patient population for which approval is being sought represents a major unmet medical need. There are no approved drugs in Europe or the United States for the post-surgical treatment of adjuvant kidney cancer, a disease characterized by a high risk of recurrence. Antigenics believes clinically relevant benefits were demonstrated with Oncophage in both recurrence-free survival and overall survival endpoints and that this benefit has persisted for nearly five years.
"With the considerable support of the urology and oncology communities, we will continue to evaluate our options for making Oncophage available to kidney cancer patients in the EU," said Garo Armen, Chairman and CEO of Antigenics.
About Oncophage
Antigenics has treated nearly 800 patients in clinical trials throughout North America and Europe with Oncophage produced in their commercial facility located in Lexington, Massachusetts. Studies with Oncophage have demonstrated efficacy signals in multiple cancers, including melanoma, glioma, colorectal, pancreatic, renal cell carcinoma, gastric cancer and non-hodgkins lymphoma.
In April 2008, Oncophage was approved in Russia for the adjuvant treatment of kidney cancer patients at intermediate-risk for disease recurrence. Pre-commercial launch activities are ongoing.
Derived from each individual's tumor, Oncophage contains the 'antigenic fingerprint' of the patient's particular cancer and is designed to reprogram the body's immune system to target only cancer cells bearing this fingerprint. Oncophage is intended to leave healthy tissue unaffected and limit the debilitating side effects typically associated with traditional cancer treatments such as chemotherapy and radiation therapy. Oncophage has been studied in Phase 3 clinical trials for the treatment of kidney cancer and metastatic melanoma and is currently being investigated in Phase 2 trials in recurrent and newly diagnosed glioma.
Oncophage received fast track and orphan drug designations from the US Food and Drug Administration (FDA) for both kidney cancer and metastatic melanoma as well as orphan drug designation from the EMEA for kidney cancer. In 2009, Oncophage also received orphan drug designations from the FDA and EMEA for glioma.
In April 2009, the World Vaccine Congress named Oncophage as the best therapeutic vaccine.
About Renal Cell Carcinoma
Renal cell carcinoma is the most common type of kidney cancer, accounting for almost 90 percent of all kidney tumors. According to a report in the Annals of Oncology, there were more than 63,000 new cases of RCC diagnosed in 2006 along with 26,000 deaths related to the disease.(1) Despite earlier detection, patients with locally advanced disease face a poor prognosis, with a 5-year survival rate of approximately 50 percent due to recurrence of disease. Currently, no approved therapies exist in the EU for use in localized disease.
About Antigenics
Antigenics is a biotechnology company working to develop treatments for cancers and infectious diseases. For more information, please visit www.antigenics.com
This press release contains forward-looking statements regarding Antigenics' business and plans, including statements regarding anticipated regulatory authority decisions and Antigenics' regulatory strategies. These forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties, include without limitation, decisions of regulatory authorities, the availability of resources, and the risk and uncertainties described in Antigenics' SEC reports filed under the Securities Exchange Act of 1934, including those mentioned in the Risk Factors section of Antigenics' Quarterly Report on Form 10Q for the quarter ended June 30, 2009. 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.
_____________________________________________
(1) Ferlay, J. et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology.18(3):581-92. March 2007.
SOURCE: Antigenics Inc.
Antigenics Inc. Media: Brad Miles, 212-477-9007 x17 or Investors: Shalini Sharp, 800-962-2436
Tags: accounting biotechnology business cancer ceo clinical commercial congress disease drugs europe fda marketing massachusetts medical nasdaq north america population products russia sec securities track vaccine
Companies: Antigenics, Inc. (AGEN)
Total : 71 View more »
The Brain Tumor Research Center at the University of California, San Francisco, has initiated a Phase 2 clinical trial evaluating the effect of Oncophage on overall survival in patients with recurrent glioma. View press release
SAN DIEGO, Calif. - - ICON Group International Ltd., today released studies on labor productivity and financial benchmarks for Antigenics Incorporated (NAS: AGEN).
http://www.icongrouponline.com/pr/Antigenics_Incorporated_US/PR.html
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Antigenics' project involved translation to support the clinical trial of the company’s personalized cancer vaccine. They required immediate translation of case report form (CRF) data for an upcoming interim analysis.
Total : 228 View more »
Biotechnology company developing cancer vaccines and other treatments for cancer and infectious diseases
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