Advaxis Reports Preclinical Study of LM-LLO; Anavex Awarded New U.S. Patent Print E-mail
By Staff and Wire Reports   
Wednesday, 04 June 2014 19:21
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 4, 2014.

Advaxis, Inc. (Nasdaq: ADXS)
, a biotechnology company developing cancer immunotherapies, announced the publication of preclinical research with its lead candidate, ADXS-HPV for the
treatment of HPV-associated cancers in the journal, Cancer Immunology Research. In this publication, researchers at the National Cancer Institute (NCI) reported on the biologic mechanisms behind the unique ability of ADXS-HPV to decrease the immunosuppressive activity of Tregs in the tumor microenvironment that result in increased anti-tumor activity. This research demonstrates the critical role of the tLLO peptide fusion and the strong adjuvant effect of tLLO as contributing to the increase in activated T-cells and the relative decrease in the number of Tregs in tumors, thereby increasing anti-tumor activity.

The research was conducted by Dr. Zhisong Chen, Dr. Samir Khleif and their research team at the Vaccine Branch, center for Cancer Research, NCI, NIH. The research was supported by the Intramural Research Program of the Center for Cancer Research, NCI, NIH and funded in part by Advaxis through a collaborative research and development agreement. The publication, entitled,
"Episomal expression of a truncated listeriolysin O (LLO) in LmddA-LLO-E7 vaccine enhances anti-tumor efficacy by preferentially inducing CD4+FoxP3- T cell and CD8+ T cell expansion," by Drs. Chen, Ozbun, Chong, Wallecha, Berzofsky, and Khleif, reported the complete regression of tumors in about 40% of mice after two vaccinations with ADXS-HPV. Furthermore, with the exception of one, these mice survived at least six months without relapse.

"This preclinical study conducted by researchers at the NCI further demonstrates how our proprietary Listeria-based cancer immunotherapy platform works, altering the microenvironment within the tumor to shrink, and in some cases, completely eliminating the tumor," said Daniel J. O'Connor, Advaxis Chief Executive Officer. "Advaxis's proprietary fusion with tLLO and the adjuvant effect of LLO in ADXS-HPV induced the strongest tumor regression."

In this preclinical study, Advaxis's Lm-based immunotherapies decreased the proportion of Tregs cells in tumors by causing preferential expansion of CD4+FoxP3- (activated) T cells and CD8+ Foxp3- (activated) T cells first in the blood and lymphoid tissue of the mice, and subsequently infiltrating the tumors and improving the ratio of activated T cells to Tregs inside the tumor microenvironment hereby enabling HPV targeted killer Tcells to eliminate the tumor. This activity was reported to be due to a mechanism dependent on and directly mediated by LLO, which was confirmed using a recombinant Lm where LLO was replaced with cytolysin Perfringolysin O (PFO) allowing exit of this strain from the phagolysosome.

"These results mark progress in our understanding of the potential mechanism behind the unique clinical activity of ADXS-HPV that has been associated with CRs, PRs and apparent prolonged survival as a single agent in recurrent cervical cancer in clinical trials," commented Dr. Robert Petit, Chief Scientific Officer of Advaxis. "The results are better than those achieved in earlier studies with different (non-Advaxis) Lm-based immunotherapies. They suggest that tLLO serves as a promising adjuvant and that its incorporation into ADXS-HPV is a critical contributor to the changes in the tumor microenvironment that favor immune killing of the tumor cells."

ADXS-HPV is in clinical trials for three HPV-associated cancers: cervical cancer, head and neck cancer and anal cancer. Advaxis reported final Phase 2 data in recurrent cervical cancer at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting and plans to move forward with a registration program in recurrent cervical cancer.



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Anavex Life Sciences Corp. (OTCQB:AVXL)
, a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, is pleased to announce that it has been issued U.S. Patent No. 8,673,931 (the "Patent"). The composition and method Patent covers ANAVEX 3-71 (formerly AF710B) for treating Alzheimer's disease (AD), type 2 diabetes and insulin resistance. ANAVEX obtained exclusive rights to worldwide patents and patent applications for ANAVEX 3-71 and related compounds in March 2014 from Life Science Research Israel, a subsidiary of the Israel Institute for Biological Research. The Patent has a term that expires no earlier than April 29, 2030.

"We are delighted to strengthen our intellectual property position with the issuance of this U.S. patent," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. "We believe the issuance of this patent validates the novelty of our platform. Additionally, we consider it to be an important step in our strategy to build and protect strong and highly differentiated small molecule therapeutics for Alzheimer's and other neurodegenerative diseases. We believe these indications are an area of significant opportunity in drug development and we look forward to leveraging our unique technology to address such therapeutic needs."

About U.S. Patent No. 8,673,931 -- The invention in this Patent covers certain bicyclic heterocyclic spiro compounds, which are thought to be ligands for G-protein coupled receptors. The active compounds function as muscarinic receptor agonists and are candidates for pharmaceutical use. There is particular emphasis on a method for the treatment of Alzheimer's disease as well as treating type 2 diabetes and insulin resistance syndrome.



Also Wednesday:



Aastrom Biosciences, Inc. (Nasdaq:ASTM)
, the leading developer of patient-specific expanded cellular therapies for the treatment of severe diseases and conditions, today announced the appointment of Gerard Michel, MS, MBA, as chief financial officer and vice president, corporate development.

Chembio Diagnostics, Inc. (Nasdaq:CEMI)
, a leader in point-of-care (POC) diagnostic tests and technology, today announced the launch of the Company's U.S. sales and marketing effort.

Diversicare Healthcare Services, Inc. (Nasdaq:DVCR)
today announced the Company's most recent growth activity.

Durata Therapeutics, Inc. (Nasdaq:DRTX)
today announced the Phase 3 data from its DISCOVER program evaluating dalbavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults was the subject of an article published in the latest edition of the New England Journal of Medicine (NEJM), "Once-Weekly Dalbavancin versus Daily Conventional Therapy for Skin Infection."

Innovus Pharmaceuticals, Inc., (OTCBB:INNV)
today announced that it will exhibit Zestra®, its topical over-the-counter ("OTC") product for female sexual arousal and desire, at the 46th Annual Meeting of the American Association of Sexuality Educators Counselors & Therapists ("AASECT") in Monterrey, CA.

K2M Group Holdings, Inc. (Nasdaq:KTWO)
today reported financial results for the three months ended March 31, 2014.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
, a provider of peripheral vascular devices and implants, today announced the closing of its previously announced underwritten public offering of 1,644,500 shares of its common stock at a price to the public of $7.00 per share.

Management of QED Connect, Inc. (OTC Pink: QEDN) (PINKSHEETS: QEDN) today announced that they completed its filings for its year end 2013 and the first quarter 2014 to be in full compliance with its disclosures and financials as required by the OTC Markets guidelines. QED's status on OTC Markets is now listed as OTC Pink Current Information.

Medical Action Industries Inc. (Nasdaq:MDCI)
, announced today that it will hold a conference call on Wednesday, June 11, 2014 at 10:00 a.m. (ET) to present its financial results for the quarter and year ended March 31, 2014.

Novavax, Inc. (Nasdaq:NVAX),
a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that it intends to offer to sell, subject to market and other conditions, $100 million of its common stock in an underwritten public offering.

OncoMed Pharmaceuticals Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, will present new data at the upcoming 19th European Hematology Association (EHA) Congress related to the company's anti-Notch1 (OMP-52M51) clinical-stage program.

Praxsyn Corporation (OTCQB:PAWS)
, a medication and service provider for medical practitioners, announced that Edward F. Kurtz, 51, has been elected to serve as the Company's Chief Operating Officer, which was effective on May 3, 2014.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP)
announced today that it has amended its lease agreement with Texas Regional Medical Center ("TRMC") in connection with the acquisition of a controlling interest in TRMC by a subsidiary of Tenet Healthcare Corporation ("Tenet").



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