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 16,000 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.

Source
Antigenics

Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) announced positive results from BLISS-76, the second of two large-scale phase III clinical trials of BENLYSTA™ (belimumab) for treating systemic lupus. A full presentation of results from BLISS-52 was recently shared at the 73rd Annual Scientific meeting of the American College of Rheumatology. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA).

Both trials demonstrate that treatment with BENLYSTA plus standard of care was superior to that of placebo (inactive agent) plus standard of care. BENLYSTA significantly reduced disease activity. If approved by the FDA, BENLYSTA would be the first drug ever developed and approved specifically for the treatment of lupus.

Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement.

“We are truly excited to receive this groundbreaking news! Individuals with lupus and their families have waited more than 50 years to hear that it is possible to develop therapies that control the disease. We believe that this is a significant first step in developing the full arsenal of therapies and personalized treatment lupus requires.

“Conducting clinical trials in lupus has been extremely difficult due to many factors including the heterogeneity of the disease, the selection of appropriate clinical trial endpoints, and the confounding role of required background medications given to clinical trial participants. Human Genome Sciences and GlaxoSmithKline have proven that these barriers, while formidable, can be overcome.

“For decades the entire lupus research community has worked hard to better understand the causes and consequences of the disease. The fruits of that labor are starting to emerge. However, now is not the time for complacency. We must band together for lupus and continue to capitalize on the decades of research made possible through the efforts of the many dedicated researchers, physicians, people with lupus, and advocates.

“This announcement by HGS and GSK and the Overcoming Barriers to Drug Development in Lupus report, commissioned by the Lupus Foundation of America to outline recommendations on ways to overcome the barriers to lupus research, combine to serve as a call to action for a national coordinated effort to accelerate the pace of discovery, to develop more tolerable and effective treatments, and to ultimately find a cure for this perilous disease.

“We congratulate HGS and GSK on reaching this important milestone in lupus research and in the development of new therapies for lupus. We also extend our appreciation to the researchers and study volunteers who made this achievement possible: the physicians who have passionately committed to researching this disease, and the companies that continue to invest in finding new and necessary treatments for this devastating disease.”

The next step in the process is for HGS and GSK to submit marketing applications in the United States, Europe and other regions during the first half of 2010. The LFA will closely follow this process, and continue to keep its constituents apprised of developments.

Source
Lupus Foundation of America

Today, Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) announced positive results from a year-long clinical trial of BENLYSTA for treating lupus. When the 52-week study concluded, the lupus patients who were treated with BENLYSTA had improvement in overall disease activity without clinically significant flare-ups in one or more isolated organs when compared to patients who received the placebo (inactive agent). The patients receiving BENLYSTA also were able to reduce their intake of steroid medications. The study is the largest ever to be completed for lupus and the first Phase III (late stage) trial of a new biologic immune therapy for lupus to succeed in meeting its primary endpoint and most of its secondary endpoints.

Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA) issued the following statement.

“For people with lupus and their loved ones, this is an historic day! With no new drugs for more than 50 years, since the Eisenhower Administration, the news today indicates that it is possible to develop new, safe, and effective therapies for lupus. We are greatly encouraged by the positive top-line data which shows that HGS’ 52-week BENLYSTA study met its primary endpoint. These results provide hope that this complex chronic autoimmune disease can be brought under control and that, eventually, a cure can be found for the estimated 1.5 million Americans and more than 5 million people worldwide living with lupus.

“We look forward to hearing the results, this fall, of a longer-term Phase III clinical study of BENLYSTA. The data from both studies will be evaluated by the U.S. Food and Drug Administration (FDA). Should the FDA ultimately approve BENLYSTA, it would become the first drug successfully developed to specifically treat lupus since the disease was discovered more than a century ago.

“Lupus is a complex disease and not every therapy will be appropriate for all patients. Each person with lupus is unique and it is likely that successful management of lupus will require a number of therapies, perhaps used in combination with each other. The LFA and its Medical-Scientific Advisory Council urge the federal government and industry to greatly step up their research efforts on lupus so that physicians have a complete arsenal of therapies at their disposal to provide the individualized treatment that lupus requires.

“We are grateful to Human Genome Sciences and GlaxoSmithKline for their pioneering efforts to develop a new, safe, effective and tolerable treatment for lupus, to the physicians who have passionately committed to researching this disease, to the companies who continue to invest in finding new treatments, and to the thousands of people with lupus who have volunteered and participated in clinical studies over the years so discoveries such as this one could be possible.

“Meanwhile, the LFA will continue to implement its initiative entitled, A New 21st Century Approach to Lupus Healthcare, to ensure the ongoing advancement of the science and medicine of lupus to meet the multi-dimensional needs of people with lupus. “

View a video of Sandra Raymond’s remarks on the LFA website.

About Lupus

Lupus is an acute and chronic autoimmune disease in which the immune system is unbalanced, causing inflammation and tissue damage to virtually any organ in the body. Its health effects include heart attacks, strokes, seizures, miscarriages, and organ failure. Ninety percent of the people with lupus are women, and it is two to three times more common among African Americans, Hispanics/Latinos, Native Americans, and Asians. Lupus is unpredictable and potentially fatal, yet no satisfactory treatment or cure exists.

Source
LFA