VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has received approval from the Medicines and Medical Device Agency of Serbia to begin enrollment of subjects in its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). Serbia is the 11th country from which approval to participate in the world’s largest Phase III trial for the treatment of head and neck cancer has been obtained. The clinical sites in Serbia are expected to become active in the next few weeks. Approximately 72 of the worldwide total of 880 patients for the study are expected to be enrolled in Serbia.

Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved by regulatory agencies (e.g. FDA) for use following completion of CEL-SCI’s clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body’s natural ability to fight tumors.

“Immunotherapy has come to be recognized as the next great breakthrough in cancer therapeutics. Science Magazine named cancer immunotherapy the Breakthrough of the Year for 2013. The magazine suggests that clinical trials have cemented immunotherapy’s potential in patients and swayed even the skeptics. Science Magazine also reports that oncologists say a corner has been turned and we won’t be going back. CEL-SCI has been an early participant in the study of cancer immunotherapeutics and it’s very exciting to see this class of cancer therapies acknowledged for its potential to transform the treatment of cancer,” stated CEL-SCI CEO Geert Kersten. “We are pleased to advance our Phase III trial, as Serbia becomes the latest country to participate in this important immunotherapy trial.”

To read the Science Magazine article in full, please visit: http://www.sciencemagazinedigital.org/sciencemagazine/20_december_2013?pg=28#pg28.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant, 10% improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only. CEL-SCI’s Multikine investigational immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of these patients.

About CEL-SCI Corporation

CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body’s natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

For more information, please visit www.cel-sci.com.

LAWRENCEVILLE, N.J., Jan. 21, 2014 /PRNewswire/ — Celsion Corporation (CLSN), a leading oncology drug development company, announced today that the company is formalizing a program to pursue the development of ThermoDox® to investigate applications for treating brain cancer tumors, notably Glioblastoma Multiforme or GBM. In addition to jointly submitting multiple grant applications, the company is also pursuing preclinical studies in collaboration with Dr. Costas D. Arvanitis at the Brigham and Women’s Hospital and Harvard Medical School. Experiments will study the use of ThermoDox in combination with MR guided High Intensity Focused Ultrasound (HIFU) to treat brain tumors, initially in animal models.

“Brain cancer tumors represent a very high unmet medical need, and researchers have been pursuing applications with HIFU for many years,” said Nicholas Borys, MD, Celsion’s Chief Medical Officer. “We are excited to investigate the addition of ThermoDox, our heat-activated liposomal encapsulation of doxorubicin, which could provide some clinical benefit for a population that desperately needs more applications.”

Dr. Arvanitis, research fellow at Brigham and Women’s Hospital and Harvard Medical School stated, “We have investigated the use of MR-guided focused ultrasound to treat brain tumors for many years and have identified the need for drugs that will improve our ability to treat brain tumors. We are excited about this drug design, which is positioned to work with heat and specifically HIFU, and its potential to cross the blood-brain barrier and potentially demonstrate drug concentration in ways that other drugs cannot. We are grateful for Celsion’s support in this research and look forward to pursuing this initial, pre-clinical research with the hope of bringing this application to the clinic in the future.”

About Glioblastoma Multiforme (GBM) Brain Tumors

Glioblastoma multiforme (GBM), WHO classification name “glioblastoma”, is the most common and most aggressive malignant primary brain tumor in humans, involving glial cells and accounting for over 50% of all functional tissue brain tumor cases and nearly 20% of all intracranial tumors. In 2013, projected US incidence of brain tumors approaches 23,000 cases, with projected mortality at 14,000. Treatment can involve chemotherapy, radiation and surgery. Median survival with standard-of-care radiation and chemotherapy is normally 15 months, and Median survival without treatment is approximately 4½ months.

About ThermoDox®

ThermoDox® is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers. In the HEAT Study, ThermoDox® is administered intravenously in combination with RFA. Localized mild hyperthermia (39.5 – 42 degrees Celsius) created by the RFA releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.

For primary liver cancer, ThermoDox® is being evaluated in a 701 patient global Phase III study at 79 clinical sites under an FDA Special Protocol Assessment. The study is designed to evaluate the efficacy of ThermoDox® in combination with RFA when compared to patients who receive RFA alone as the control. On January 31, 2013, Celsion announced that ThermoDox® in combination with RFA did not meet the primary endpoint of the HEAT study in patients with hepatocellular carcinoma, also known as primary liver cancer. Celsion has conducted a comprehensive analysis of the data from the Phase III HEAT Study with key principal investigators, data experts and liver cancer experts. Emerging data from the HEAT Study post hoc analysis demonstrates that ThermoDox® markedly improves PFS and overall survival in patients if their lesions undergo RFA for 45 minutes or more. These findings apply to HCC lesions from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a sizable subgroup of approximately 300 patients.

About Celsion Corporation

Celsion is dedicated to the development and commercialization of innovative cancer drugs, including tumor-targeting treatments using focused heat energy in combination with heat-activated liposomal drug technology. Celsion has research, license or commercialization agreements with leading institutions, including the National Institutes of Health, Duke University Medical Center, University of Hong Kong, the University of Pisa, the UCLA Department of Medicine, the Kyungpook National University Hospital, the Beijing Cancer Hospital and the University of Oxford. For more information on Celsion, visit our website: http://www.celsion.com.

HAIFA, Israel, Jan. 23, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell product candidates, today announced it has received approval from the Paul-Ehrlich-Institute (PEI), Germany’s health authority, to supply cells from its advanced, fully automated, and proprietary 3D cell expansion manufacturing platform implemented at its new state-of-the-art GMP facility. Pluristem’s new manufacturing facility has the capability to efficiently produce over 150,000 doses of PLX cells annually, which potentially translates into significant economic value.

This marks the first regulatory approval of Pluristem’s new facility where the company has implemented its large scale 3D bioreactor expansion of placental-derived mesenchymal-like Adherent Stromal Cells (ASCs). The approval will enable the company to easily support ongoing trials and enter into multiple clinical trials using its scale-up capabilities for cell supply. The company is also in the process of getting approvals from other regulatory authorities including the US FDA.

“We are very pleased to receive the PEI’s approval. Following our multi-million dollar investment into the development of our proprietary high-throughput culturing technologies, 3D bioreactors, and proprietary downstream equipment, the PEI’s approval confirms Pluristem’s unique position in the cell therapy industry. Our proprietary 3D manufacturing process can create commercial quantities of cells with batch-to-batch consistency, so we are ready to expand and accelerate our clinical programs,” stated Zami Aberman, Chairman and CEO of Pluristem. “In addition, the very encouraging results of our Phase I/II trial in muscle injury conducted in Germany suggest that our unique culturing technology may contribute to the quality and consistency of PLX clinical studies.”

About Pluristem’s 3D Manufacturing

Pluristem’s state-of-the-art manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and therefore invests major efforts in developing highly efficient, cutting-edge culturing systems enabling advancement of its large PLX cell therapy product candidate’s pipeline.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company’s patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company’s proprietary 3D micro-environmental technology and are an “off-the-shelf” product that requires no tissue matching prior to administration.

Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.

NEW YORK, NY–(Marketwired – Jan 22, 2014) – SmartMetric, Inc. (OTCQB: SMME), a developer of patented payment card technology and in-card biometric products, announced today that it has created a sub-micro operating system for nano-computers. The SmartMetric Intelligent Card OS™ is an operating system that unlocks new possibilities for software and app development for a payment card-sized device that has broad functionality, comparable to a smartphone or tablet.

“We’ve seen the evolution of computing move from mainframe, to PC, to tablets, and then to smartphones. Now, SmartMetric is leading the next wave of miniaturization with our SmartMetric intelligent card. Combining our patented nano-computing hardware with our sub-micro operating system, we believe we’ve created the next new device of the future and it’s the size of a payment card,” stated SmartMetric President and CEO Chaya Hendrick.

SmartMetric’s operating system is designed to run on the SmartMetric intelligent card, which combines biometrics with patented nano-computing technology, the world’s smallest fingerprint reader, an internal ARM 9 processor, processing power equal that of a PC, and up to 128 gigabytes of memory, matching the maximum memory capacity of current iPads.

Powered by SmartMetric’s operating system, developers can now create never before possible apps that run on a payment card, for a broad range of functions including gaming, security, consumer, and industrial. Developers interested in creating apps for the SmartMetric card may contact: chaya@smartmetric.com.

About SmartMetric

SmartMetric, Inc. (OTCQB: SMME) develops patented card technologies used for payments, security and identification, including the world’s smallest in-card fingerprint reader. The Company’s proprietary advanced miniature electronics technology uses sub-micro computers to create fingerprint and security applications that were not previously possible. The world’s smallest fingerprint reader is designed to fit inside standard payments cards as well as ID cards. Because of the miniature size of the electronics it is ideal for use in a broad array of products requiring an enhanced identification system. SmartMetric’s products include biometric credit card and biometric debit card technologies, a medical emergency biometric card, and a MedicalKeyring™. For information on SmartMetric and its technology please go to www.smartmetric.com.