GSK’s MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Melanoma Misses First Co-Primary Endpoint

Agenus Inc. today announced that GlaxoSmithKline’s (NYSE:GSK) DERMA study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeutic (CI) trial, which contains Agenus’QS-21 Stimulon^® adjuvant, a component of GSK’s novel adjuvant system AS15, did not meet its first co-primary endpoint. Buy Benzac (Benzoyl Peroxide) pills online without prescription In an independent analysis, the study did not significantly extend the disease-free survival (DFS)^iv period when compared to placebo in the overall MAGE-A3 positive trial population.

“In the near future, we expect to report results of several other QS-21 Stimulon adjuvant containing programs.”

In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the study until the second co-primary endpoint is assessed. This co-primary endpoint is based on predefined criterion that was agreed upon by regulatory authorities. This analysis, which is based on gene signature, is designed to prospectively identify patients who may have the capability to be more immunologically responsive and therefore can potentially benefit from treatment. Buy Betagan (Levobunolol) tabs online without prescription If further analysis shows that the predefined gene signature subset data are successful, there is the potential that a regulatory filing could be considered. GSK anticipates that these data will be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data.
The IDMC for the DERMA study indicated that the current review of the safety information raised no concern for the continuation of the trial.
“We continue to believe that cancer immunotherapeutics have the potential to deliver significant benefits to patients and we look forward to the analysis of gene signature data,” said Garo H. Armen, Ph.D., chairman and CEO of Agenus Inc. Buy Timoptic (Timolol) without prescription “In the near future, we expect to report results of several other QS-21 Stimulon adjuvant containing programs.”
QS-21 Stimulon adjuvant is key component of many vaccines currently in clinical development. Agenus expects to report Phase 2 data for HerpV, Agenus’QS-21 Stimulon containing investigational therapeutic vaccine for genital herpes, during the fourth quarter of 2013. GSK is expected to announce Phase 3 results from MAGRIT, the MAGE-A3 non-small cell lung cancer (NSCLC) clinical trial during the first half of 2014. Buy Vitamins online In addition, GSK is expected to provide an update to the RTS,S program for the prevention of malaria.
About MAGE-A3 and GSK’s Cancer Immunotherapeutics (CIs)
MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of cancers, including melanoma, NSCLC, head and neck cancer, and bladder cancer, with no expression in normal cells^v.
GSK's CIs represent a class of novel investigational compounds that are based on tumor antigens presented to the patient's immune system as recombinant proteins in combination with a GSK novel adjuvant system. future Pharmaceuticals CIs are designed to trigger a specific immune response against tumor cells expressing these proteins, rallying antibodies and T-cells to recognize and attack the cancer cells in a highly specific manner and eventually eliminate them.
This approach primarily aims at reducing the risk of tumor recurrence following surgery. The highly targeted mode of action of GSK CIs against specific cancer antigens expressed by tumor cells may allow selection of patients eligible for the treatment depending on the expression of the tumor antigens. All Best Rx : Buy drugs online This may help oncologists to select patient populations most likely to respond to the treatment.
GSK’s MAGE-A3 CI contains a purified recombinant MAGE-A3 protein combined with GSK's novel AS15 adjuvant system. It was developed with the goal of inducing strong and sustained immune responses. AS15 is composed of the QS-21 Stimulon adjuvant, monophosphoryl lipid A (MPL), and CpG7909, a TLR-9 agonist, in a liposomal formulation.
Adjuvants are substances, which when used in combination with antigens in vaccines, enhance the immune response.
About Agenus’ QS-21 Stimulon^® Adjuvant
Agenus’ flagship adjuvant, QS-21 Stimulon adjuvant, is a saponin extracted from the bark of the Quillaja saponaria tree, also known as the soap bark tree or Soapbark, an evergreen tree native to warm temperate central Chile. FDA Approved Rx : Online Pharmacy Agenus’ QS-21 Stimulon has become a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases, and appears to be essential for several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. QS-21 Stimulon has been widely studied and approximately 50,000 patients have received vaccines containing the adjuvant. QS-21 Stimulon is being studied in 21 vaccine indications, which include GSK’s Phase 3 vaccine programs for RTS,S for malaria, MAGE-A3 cancer immunotherapeutic for non-small cell lung cancer and melanoma and HZ/su for shingles. Drugs Rx Guide : Buy drugs online In addition, Janssen’s QS-21 Stimulon adjuvant-containing vaccine candidate is in Phase 2 trials for the treatment of Alzheimer’s disease, and Agenus’ HerpV, a therapeutic vaccine for the treatment of genital herpes, is in a Phase 2 trial with data expected during the fourth quarter 2013. Agenus is generally entitled to receive milestone payments as QS-21 Stimulon containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions.
About GSK’s DERMA Program
The GSK DERMA study evaluated the efficacy and safety of the MAGE-A3 cancer immunotherapeutic, when compared to placebo, in MAGE-A3 positive patients (those whose tumor shows expression of the MAGE-A3 gene) with Stages IIIB/C surgically resected melanoma. The MAGE-A3 antigen is expressed in approximately 65% of tumors in Stage III melanoma patients.
The DERMA trial randomized 1,345 patients and is being conducted in 33 countries. In accordance with the study protocol, patients were given up to 13 injections into the muscle of the upper arm or thigh, over a period of 27 months.
About Melanoma
Melanoma is the most aggressive form of all skin cancers and its incidence is rising at a rate exceeding all other cancers. Worldwide, it is believed that approximately 160,000 people will be diagnosed with melanoma each year. If detected in its earliest stages and treated properly, melanoma is curable, however, melanoma is more likely than other skin tumors to spread to other parts of the body. Patients with stage IIB-C and stage III (locoregional lymph-node involvement) melanoma have a high risk of relapse following surgery (60% and 75% risk of recurrence, respectively). There are limited options for patients with advanced melanoma disease, highlighting that this type of melanoma represents an area of high unmet medical need.
About Agenus
Agenus Inc. is a biotechnology company working to develop treatments for cancers and infectious diseases. The company is focused on immunotherapeutic products based on strong platform technologies with multiple product candidates advancing through the clinic, including several product candidates that have advanced into late-stage clinical trials through corporate partners.

Lipocine Inc. Announces Reverse Merger and $38 Million Private Placement to Advance its Oral Testosterone Product Portfolio

Lipocine, Inc. a specialty pharmaceutical company, announced today that it has entered into securities purchase agreements with gross proceeds of $38.0 million for the issuance and sale of approximately 6.3 million shares of its common stock at $6.00 per share to institutional investors. The closing of the private placement is subject to customary closing conditions. Buy Premarin (Conjugated,Estrogens Usp) without prescription Proceeds from the private placement will be used primarily to advance Lipocine’s oral testosterone portfolio, LPCN 1021 and LPCN 1111.
On July 24, 2013, Lipocine successfully completed a reverse merger with Marathon Bar Corp. The combined company will focus solely on the business of Lipocine. Buy Vantin (Cefpodoxime) tabs online without prescription Lipocine will trade under the symbol “MBARD” on the OTCBB until on or about August 22, 2013, when it will be quoted under the symbol “LPCN” on the OTCBB.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. , is serving as the exclusive placement agent on the private placement.
In connection with the private placement, Lipocine has agreed, subject to certain terms and conditions, to file a registration statement under the Securities Act of 1933, as amended, covering the resale of the shares of common stock, within 30 days after the closing. Buy Vaseretic (Enalapril-Hydrochlorothiazide) pills online without prescription The shares of common stock to be issued and sold pursuant to the securities purchase agreements have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission or an applicable exemption from the registration requirements.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, Buy Vitamins online solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About Lipocine Inc.
Lipocine Inc. is a specialty pharmaceutical company developing innovative products for use in men’s and women’s health using its proprietary drug delivery technologies. Lipocine’s lead product candidate, LPCN 1021, is Phase III ready and is targeted to treat symptoms of low testosterone for men in need of testosterone replacement therapy. TranScrip Partners Announce US Expansion This product candidate is designed to provide twice-a-day oral dosing. Additional pipeline candidates include LPCN 1111, a next generation longer-acting oral testosterone therapy product and LPCN 1107, potentially the first oral product for the prevention of preterm birth. All Best Rx : Buy drugs online
Forward-Looking Statements
Any forward-looking statements in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include all statements relating to the anticipated closing of the private placement and proposed use of proceeds, and the potential benefits of Lipocine’s product candidates. FDA Approved Rx : Online Pharmacy Investors are cautioned that all forward-looking statements involve risk and uncertainties, including without limitation the risks related to the satisfaction of the conditions to, and the timing of, the closing of the private placement; Lipocine’s need for additional capital in the future; Drugs Rx Guide : Buy drugs online the receipt of regulatory approvals and other risks detailed in Lipocine's filings with the U.S. Securities and Exchange Commission, including without limitation its Current Report on Form 8-K, dated July 24, 2013.