|GlaxoSmithKline Throws in Towel on Lung Cancer Vaccine Trial; Alliance & 21st Century to Enroll Patients in CEL-SCI’s Global Phase III Cancer Trial|
|By Staff and Wire Reports|
|Wednesday, 02 April 2014 20:14|
GlaxoSmithKline Plc (NYSE: GSK) has stopped a high-profile clinical trial using a novel vaccine to fight lung cancer after deciding it will not be possible to find a sub-group of patients who might benefit.
The decision comes less than two weeks after GSK said the MAGE-A3 therapeutic vaccine did not help patients with non-small cell lung cancer in the Phase III study overall, but it was still looking for improvements among patients with a particular genetic profile.
In the event, scientists analyzing the trial decided there was insufficient treatment effect to pinpoint benefit in such gene-signature patients.
Vincent Brichard, head of immunotherapeutics at GSK Vaccines, who announced the decision on Wednesday, said he was "extremely disappointed" by the result.
Identifying a sub-group for whom MAGE-A3 would work had been considered a long shot by investors. Nonetheless, Citi analyst Andrew Baum said the latest setback removed "important optionality" for future sales and profits.
A second trial testing the vaccine in melanoma, which also failed to help patients overall, will continue to investigate benefits in sub-populations. However, the commercial opportunity in melanoma is only 20 to 30 percent that of lung cancer, according to Citi. The outcome of the melanoma research is expected in 2015.
Unlike traditional preventative vaccines, the MAGE-A3 treatment was designed for people with established disease, helping their immune systems to prevent the return of disease after surgery.
Other companies, including Bristol-Myers Squibb Co, Roche Holding AG and Merck & Co Inc, have had some recent notable successes in clinical trials of innovative drugs to boost the immune system, but GSK's vaccine-based approach is different and has met with less success.
Shares in Britain's biggest drugmaker were 0.7 percent lower at 0750 GMT, underperforming a 0.3 percent decline in the European drugs sector. MAGE-A3 is one of two high-risk, high-reward research projects that GSK has invested heavily in over recent years - so far, to little avail.
Its experimental heart drug darapladib, which fights clogged arteries in a novel way, has also failed to hit its goals in a late-stage clinical trial, although GSK still hopes a second study may succeed.
U.S.-based Agenus Inc has contributed technology to GSK's MAGE-A3 vaccine and its shares are sensitive to news on the project. The vaccine contains Agenus' QS-21 Stimulon adjuvant, or booster.
CEL-SCI Corporation (NYSE MKT: CVM) announced it has expanded its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the U.S. with the addition of a new site in Scottsdale, Arizona. The 21st Century Oncology clinic in Scottsdale, along with the Arizona Cancer Research Alliance, has just joined the study and is actively screening patients for enrollment into the trial. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer.
“Our clinical trial is now active in over 40 medical centers internationally and we are pleased to expand the number of sites in the U.S. More American patients now have the option of enrolling in this trial for Multikine, which aims to use the body’s own natural immune system to fight cancer. We look forward to working with 21st Century Oncology, and the Arizona Cancer Research Center to bring the potential of this innovative new method of treating cancer patients to Arizona,” stated CEL-SCI Chief Executive Officer Geert Kersten.
The Arizona Cancer Research Alliance (ACRA) is a community-based network for testing and validating medical interventions with the potential to diagnose, treat, ameliorate or cure cancer. The alliance is focused on creating infrastructure to support physicians who are believed to be responsible for over 80% of the care provided to patients with cancer.
21st Century Oncology is the largest global, physician-led provider of integrated cancer care services, operating 166 treatment centers, with 133 centers in 16 states in the U.S. and 33 centers in six Latin American countries.
The Principal Investigator for the Scottsdale site is Dr. Steven Finkelstein, whose clinical expertise includes radiation oncology, surgical oncology and clinical immunotherapy in the treatment of head and neck malignancies, prostate, breast, lung, and colorectal cancers. Dr. Finkelstein is a Scottsdale Board Certified Radiation Oncologist, National Director of the Translational Research Consortium, Adjunct Associate Professor at Translational Genomic Research Institute, and Executive Director of the Arizona Cancer Research Alliance.
21st Century Oncology’s Scottsdale clinic is the organization’s second clinic to join CEL-SCI’s trial as part of the CEL-SCI trial expansion. CEL-SCI recently announced 21st Century Oncology’s Greenville, North Carolina site had also joined the study.
Multikine* (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in a global, multi-center, randomized, controlled, pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100-110 clinical centers in about 20 countries.
In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further the clinical development of Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.
3D Systems (NYSE:DDD) announced that it acquired Medical Modeling Inc., a leading provider of personalized surgical treatments and patient specific medical devices, including virtual surgical planning and clinical transfer tools, using 3D modeling and printing that is rapidly changing how reconstructive surgery is done today.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. BG Medicine also expects to grant the underwriters a 30-day option to purchase additional shares of common stock to cover over-allotments, if any.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, announced today that Dr. Derek Chalmers, President and CEO, will present a company overview at the 13th Annual Needham Healthcare Conference on Wednesday, April 9, 2014 at 9:20 a.m. ET in New York City.
Cellectar Biosciences, Inc. (OTCQX:CLRB), a clinical stage biopharmaceutical company developing innovative agents for the detection and treatment of cancer, announced that effective April 1, 2014, Dr. Simon Pedder transitioned to President and CEO of Cellectar as planned following six months as acting chief executive officer.
Curis, Inc. (Nasdaq:CRIS), an oncology-focused drug development company seeking to develop novel drug candidates for the treatment of human cancers, today announced that the Company will present at the 13th Annual Needham Healthcare Conference at 1:40 p.m. ET on April 9, 2014, in New York City.
Endocyte, Inc. (Nasdaq:ECYT) announced today the closing of its previously announced underwritten public offering of 5,175,000 shares of its common stock at a price to the public of $21.00 per share, which includes the exercise in full by the underwriters of their option to purchase 675,000 additional shares.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that CEO Michael Clayman, M.D., will present an overview of the company at the 13th Annual Needham Healthcare Conference.
India Globalization Capital, Inc. (NYSE MKT: IGC), announced today that it has received commitments from investors to purchase $506,250 of its Common Stock in a registered direct offering.
With the open enrollment period of the Affordable Care Act ending March 31, Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer, virtual administrator and private exchange for affordable, cloud-based individual health insurance plans and ancillary products, encourages uninsured Americans to consider alternative health insurance plans.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX) today announced that the European Medicines Agency ("EMA") has determined that the Company's Marketing Authorization Application ("MAA") seeking the approval of Zerenex™ (ferric citrate coordination complex) as a treatment for hyperphosphatemia in patients with chronic kidney disease ("CKD"), including dialysis- and non-dialysis-dependent CKD, is valid.
LDR Holding Corporation (Nasdaq:LDRH), a global medical device company focused on designing and commercializing novel and proprietary spinal surgical technologies, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission ("SEC") relating to a proposed follow-on public offering of its common stock.
Medical Marijuana Inc.'s (OTC Pink:MJNA) HempMedsPX™ – a corporate portfolio company of Medical Marijuana Inc. and the exclusive master distributor and contracted marketing company for Medical Marijuana, Inc. and its portfolio of companies – has finalized a strategic marketing partnership with Medical Cannabis Network (MCN). MCN will directly market HempMedsPX™ through its MarijuanaDoctors.com and PotLocator.com brands.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company, announced today that Stanley C. Erck, President and Chief Executive Officer, will present at the 13th Annual Needham Healthcare Conference on April 9, 2014 at 12:10 pm ET in New York City at the Westin Grand Central Hotel.
Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), today announced the closing of its subsidiary, Ruthigen, Inc.'s (Nasdaq:RTGN), initial public offering on the NASDAQ Capital Market on March 26, 2014.
Pacific Biosciences of California, Inc. (Nasdaq:PACB) will hold its quarterly conference call to discuss its First Quarter 2014 Financial Results on Wednesday, April 30, 2014, at 4:30pm Eastern Time.
Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT), a leader of specialty pharmaceutical products with an emphasis on the injectable market, today announced that it will present at the 13th Annual Needham Healthcare Conference in New York on Wednesday, April 9, 2014 at 11:20 a.m. EDT.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that updated data from the ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS) will be presented at the American Association for Cancer Research Annual Meeting 2014 (AACR) in San Diego, California.