VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that Aintree University Hospital, in Liverpool, England, has become a clinical site for the Company’s global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This is the first center to join the Multikine Phase III study in the UK.

Aintree University Hospital is a large teaching hospital in Liverpool providing a range of acute and non-acute specialties. The hospital offers specialist services with a world-class reputation to a population of 1.5 million residents across the Northwest of England. The Principal Investigator for the trial site is Professor Richard Shaw. He serves as Honorary Consultant in Oral & Maxillofacial / Head and Neck Surgery at Aintree University Hospital and is a surgeon specializing in head and neck cancers at the University of Liverpool.

“Dr. Shaw is a Key Opinion Leader in head and neck cancer who has participated in numerous trials exploring better ways to treat cancer. We are honored to have his participation and expertise in our trial.” stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

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 improvement in the 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. A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in about 25 countries.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that in March it has enrolled 29 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). March marks the third consecutive month of record enrollment for CEL-SCI this year following January and February 2015. 406 patients have been enrolled in the Phase III study as of March 31, 2015.

“The accelerating pace of enrollment in our trial is very good. We expect to see continued increases in monthly patient enrollment throughout the year as new clinical centers are added and as existing centers gain more experience with Multikine,” stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine Phase III Study

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 improvement in the 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.

WILMINGTON, Mass., March 26, 2015 /PRNewswire/ — Implant Sciences Corporation (IMSC), a leading manufacturer of explosives trace detection (ETD) and drugs trace detection solutions for homeland security applications, today reported the shipment of approximately $500,000 in explosives trace detection systems in Latin America, most of which were sold to a major international airline in Latin America.

“Implant Sciences continues to expand its market share in the Latin American aviation security space. We believe that the combination of our superior performance and value proposition is the impetus behind this success, which could also set the stage for follow-on orders from these customers,” stated Dr. Darryl Jones, Implant Sciences’ Global Vice President of Sales and Marketing. “We are seeing a significant increase in demand for our products since our recent checkpoint certifications from the US Transportation Security Administration (TSA) and the European Civil Aviation Conference (ECAC).”

“Our QS-B220 is specifically designed to meet the needs of aviation-related applications, including passenger, baggage, and cargo screening. As the only non-radioactive ETD in the world to pass the latest testing protocols of both TSA and ECAC, the QS-B220 is becoming the ETD of choice for a larger number of purchasers in the aviation security market,” added Dr. Bill McGann, CEO of Implant Sciences.

JERUSALEM, April 1, 2015 /PRNewswire/ —

Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today the first patient has been enrolled in its Glucose Clamp Study. The study will be performed at The University of Texas Health Science Center at San Antonio and University Health System’s Texas Diabetes Institute under the supervision of Professor Ralph DeFronzo.

The glucose clamp is a method for quantifying insulin absorption in order to measure a patient’s insulin sensitivity and how well a patient metabolizes glucose. The glucose clamp technique represents the gold standard for pharmacodynamic studies in diabetes drug development.

In addition to the clamp study, Oramed plans to initiate its Phase IIb oral insulin trial in the U.S. with a protocol which includes over 30 U.S. sites covering approximately 180 patients and has both efficacy and safety as its primary end-points.

“We are pleased to have initiated this study and enrolled the first patient. We are additionally excited at the prospects of starting our larger Phase IIb trial in the near term. The data from the two trials will allow for a clearer picture of our oral insulin and its pharmacological characteristics as we move forward with our development plan,” stated Oramed CEO Nadav Kidron.

PETACH TIKVA, Israel, March 18, 2015 /PRNewswire/ — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA), a biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, announced today it has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite’s drugs, which are currently in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.

A3AR is present in high concentrations in inflammatory cells and cancer cells. Can-Fite’s proprietary drugs target and bind to A3AR, causing cancer and inflammatory cell apoptosis (programmed cell death). This creates a targeted anti-cancer and anti-inflammatory effect, while leaving normal cells unharmed. Identifying patients with elevated A3AR levels would indicate which patients would benefit most from Can-Fite’s drugs, thereby offering personalized medicine.

“The completion of the development of our commercial A3AR biomarker test kit comes at a very important time since we plan to use the test kit in our upcoming advanced clinical studies. We believe the test kit will create efficiencies in our trials in patient enrollment and monitoring. As we progress into late-stage clinical trials for CF101 in auto-immune diseases, our A3AR biomarker test kit is ready for wide-scale use to help doctors and their patients identify who will be most responsive to Can-Fite’s drugs. We believe these patients can significantly benefit from personalized medicine due to the high degree of clinical heterogeneity,” stated Can-Fite CEO Dr. Pnina Fishman.

The U.S. Patent and Trademark Office issued Can-Fite a patent for the utilization of A3AR as a biomarker to predict patient response to its drug CF101 in autoimmune inflammatory indications. In December 2013, Can Fite reported favorable results from its Phase IIb rheumatoid arthritis clinical trial for CF101, an A3AR agonist. Only patients with elevated baseline expression levels of the biomarker A3AR were enrolled in the study. CF101 met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of rheumatoid arthritis.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (CFBI.TA) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s CF101 is in Phase II/III trials for the treatment of psoriasis and the Company is preparing for a Phase III CF101 trial for rheumatoid arthritis. Can-Fite’s liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company’s CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication. These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com

CAESAREA, Israel, March 18, 2015 /PRNewswire/ — LabStyle Innovations Corp. (DRIO), developer of the Dario™ Diabetes Management Solution, today reported that it has concluded a 368 patient user performance study on the Dario. The results showed that usability of the Dario Diabetes Management Solution is simple and intuitive. The accuracy of Dario has proven to surpass other glucose meters and delivers accuracy that exceeds the minimum new stringent guidance of the ISO 15197:2013.

The successful clinical study is an important milestone, it allows the completion of the 510(k) application for Dario and is a significant step towards the Dario anticipated approval and commercialization in the USA.

The comparative, observational, single-arm User Performance Evaluation study was performed in Columbus Ohio, USA and consisted of 368 subjects having Type I or Type II diabetes. The study was conducted using the Dario all-in-one blood glucose monitoring solution indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The objectives of the study were to evaluate the performance of blood glucose levels taken from the Dario meter compared to the industry’s standard references for usability and performance. The study criteria was derived using a combination of the European ISO-15197:2013 In Vitro Diagnostic Test Systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus standard as well as the FDA’s more stringent draft guidance for Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use document issued on January 7, 2014.

LabStyle also announced the addition of Mr. Bill McGrail to its management team as VP Regulatory. Mr. McGrail brings to Dario over 25 years of experience in the medical device industry particularly new product development of blood glucose meters and regulatory and quality affairs for clearance and distribution of medical products in the U.S., European Union, Canada and a number of other foreign markets. Mr. McGrail is a valuable strategic addition to the Dario team and will lead and support Dario through the regulatory approval process as well as the anticipated introduction to the US market.

In previous roles, Mr. McGrail served as VP of Research and Development for AgaMatrix Inc., where he was responsible for the design and development of state of the art blood glucose meters. As VP of Regulatory, Quality and Clinical, he was responsible for the worldwide clearance of the blood glucose meters and fully integrated mobile health manager apps.

Erez Raphael, president and chief executive officer of LabStyle Innovations, stated “We are very pleased with the results of this important study. The successful study shows that the Dario™ Blood Glucose Monitoring System is highly comparable to its predicate device and can be a valuable tool to the US diabetic community. Mr. Raphael continued; “We welcome Bill McGrail to our management team. We are confident that his vast experience and knowledge in the area of blood glucose meters, their regulation and global distribution will accelerate our regulatory approval and distribution roadmap.”

DURHAM, N.C., March 9, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (“Heat”) (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for HS-410 (vesigenurtacel-L) for the treatment of non-muscle invasive bladder cancer (NMIBC). HS-410 is Heat’s NMIBC product candidate and is based on its cutting-edge Immune Pan Antigen Cytotoxic Therapy (“ImPACT”) platform that is designed to generate killer T cells to attack cancers. HS-410 is currently being evaluated in a randomized Phase 2 trial in combination with BCG and as monotherapy for the treatment of NMIBC.

“We are very pleased that FDA has granted this important designation for HS-410,” said Melissa Price, Ph.D., Heat’s Vice President of Clinical Development and Regulatory Affairs. “The decision underscores the unmet need for bladder cancer treatments and serves as an additional validation for our clinical program. Currently there are limited therapeutic treatment options available for this patient population, with no new treatments approved in this setting in over 30 years.”

About FDA Fast Track Designation

The FDA established the Fast Track Drug Development Program under the FDA Modernization Act of 1997. The program is designed to facilitate the development and expedite the review of therapies intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The advantages of Fast Track designation include actions to expedite development, including opportunities for frequent interactions with the FDA review team to discuss all aspects of development to support approval and eligibility for priority review depending on clinical data at the time of Biologics License Application (BLA) submission.

About Bladder Cancer and HS-410

According to the American Cancer Society, bladder cancer is the fifth most common cancer in the US with approximately 75,000 new cases in 2014 and 16,000 deaths. About 75% of the newly diagnosed patients have NMIBC. A key issue for bladder cancer is the high rate of recurrence, for which limited treatment options are available beyond complete bladder removal. Heat Biologics is examining candidate HS-410 in conjunction with standard treatment to stimulate the immune system and eliminate remaining cancer cells to prevent recurrence. The Company completed enrollment in a Phase 1 study and is expected to release interim data on 10 patients in the first half of 2015. A Phase 2 clinical trial is ongoing with a primary endpoint of recurrence-free survival. Heat is expected to complete enrollment in the Phase 2 study in the third quarter of 2015, which would make topline data available in the second half of 2016.

DURHAM, N.C., Feb. 26, 2015 (GLOBE NEWSWIRE) — Heat Biologics, Inc. (HTBX), a clinical stage biopharmaceutical company focused on the development of cancer immunotherapies, is today providing an update on its clinical program in non-muscle invasive bladder cancer (NMIBC) at a Key Opinion Leader (KOL) event being held this morning in New York.

Adding Monotherapy Arm To Ongoing Phase 2 Trial For HS-410 In The Treatment Of Non-Muscle Invasive Bladder Cancer

Heat announced it is adding a fourth monotherapy arm to its ongoing Phase 2 study evaluating HS-410 (vesigenurtacel-L) in the treatment of NMIBC. The decision was made after observing a vaccine-induced immune response in Phase 1 patients who received HS-410 after BCG (Bacillus Calmette–Guerin). Additionally, an intermittent global shortage of BCG provides an opportunity to evaluate the efficacy of single agent HS-410 in the treatment of NMIBC. The additional arm will be open-label and should not disrupt the timeline for reporting on the existing randomized portion of the trial. Heat currently anticipates enrolling and randomizing 75 patients into the first three clinical trial arms by the end of the third quarter 2015 as previously reported, and enrolling an additional 25 patients in the monotherapy arm by the end of 2015. Data from this study will aid in the design of Heat’s Phase 3 study of HS-410 in NMIBC. Depending on the results observed in the Phase 2 study, the Phase 3 may be designed to study HS-410 either as an adjunct to BCG or a replacement for BCG altogether.

The Company has also procured its own supply of BCG in order to ensure it has sufficient amount to continue treating patients and maintain its clinical program on schedule and to mitigate the risk of delays in the event of continued commercial shortages.

Forms Partnership With SUO-CTC To Support Accelerated Phase 2 Trial Enrollment

The Company also announced it has engaged with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), a cooperative group that represents urological oncologists and related specialists from over 160 institutions and hospitals in the United States and Canada, to support the goal of accelerating its Phase 2 enrollment in NMIBC and to begin planning for the Company’s Phase 3 trial. The ongoing trial is actively enrolling from SUO-CTC centers and other non-affiliated centers.

Melissa Price, Ph.D., Heat Biologics’ Vice President of Clinical and Regulatory Affairs, noted, “Our new monotherapy arm enables us to evaluate HS-410 as a single agent which may play an important role in our eventual Phase 3 design. This addition, combined with the accelerated enrollment through our collaboration with SUO-CTC, enables more rapid advancement of our clinical development strategy.

“We will be reporting on a number of critical milestones in 2015 including an analysis of the immune response of bladder and lung cancer patients and the completion of enrollment expected from our two Phase 2 trials in bladder cancer and NSCLC, all in the second half of 2015. We are enthusiastic about Heat Biologics’ potential to succeed in combating these cancers through our novel therapy.”

A live webcast and replay of the KOL event will be available at the “Investors” section of the Company’s website at http://ir.heatbio.com/events-presentations.

HAIFA, Israel, March 3, 2015 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI.TA) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today strong positive data from a preclinical study of PLX-R18 cells to improve outcomes of bone marrow transplantation. In the study, conducted in conjunction with Hadassah Medical Center’s Department of Bone Marrow Transplantation and Cancer Immunotherapy, mice with damaged bone marrow who received intramuscular injections of PLX-R18 cells together with a bone marrow transplant had significantly faster recovery of blood cell production compared to those who received a placebo with the bone marrow transplant. A rapid return to normal blood cell counts is critical for people who require a transplant to replace dysfunctional bone marrow because of diseases such as leukemia or other blood cancers. PLX-R18, Pluristem’s second product, is being developed to treat a range of hematologic indications including bone marrow deficiency and complications of bone marrow and umbilical cord blood transplantation.

The objective of the Hadassah trial was to compare the production of blood cells after intramuscular injection with PLX-R18 cells or placebo in the context of transplantation of hematopoietic stem cells obtained from bone marrow. Mice received lethal doses of radiation followed by either a low dose or a high dose of bone marrow cells and either PLX-R18 cells or placebo. Evidence of more rapid recovery was found at the two earliest data collection time points of the study. Nine days after transplantation with a low dose of bone marrow cells and concurrent administration of either PLX-R18 or placebo, those treated with PLX-R18 had statistically significant increases in numbers of platelets and granulocytes as compared to controls; they also had more lymphocytes and total white blood cells, though these increases were not statistically significant. Nine days after transplantation with a high dose of bone marrow cells and concurrent administration of either PLX-R18 or placebo, those treated with PLX-R18 also had statistically significant increases in platelet levels. One week later, at 16 days after a low dose transplantation, those treated with PLX-R18 cells had more platelets than controls, and those treated with PLX-R18 and a high dose of bone marrow had statistically significant increases in platelets, granulocytes and total white blood cells. After a bone marrow transplant patients cannot fight infections or prevent hemorrhage until white blood cell and platelet levels return to normal. The accelerated recovery of platelet and white blood cell levels demonstrated in this study could potentially have important clinical implications.

Alongside the study at Hadassah, a preliminary study was conducted by Hillard M. Lazarus, MD, a Professor of Medicine in the Department of Hematology and Oncology at Case Western Reserve University. The study was part of ongoing research there to test PLX-R18 for use in umbilical cord blood stem cell transplantation. Data in eight mice showed that six weeks after exposure to high doses of radiation, followed by transplantation with human umbilical cord blood cells, three out of four mice who received PLX-R18 cells survived compared to only one out of the four who received a placebo after transplant. At eight weeks after irradiation and transplantation the mice who received PLX-R18 each had a higher percent of hematopoietic cells (CD45+) in their peripheral blood than the surviving control subject. This early finding is encouraging as research continues at Case Western University to study the effects of PLX-R18 on the speed and success of engraftment of umbilical cord blood cells.

“A statistically significant increase in blood counts soon after bone marrow transplant is very meaningful. For the transplant patient, the most critical period for hematopoietic recovery is in the days following the transplant. We were particularly encouraged to see that the administration of PLX-R18 cells resulted in the greatest early improvement when using a lower dose of bone marrow cells. This means we could one day potentially achieve success with lower bone marrow transplant doses, thus addressing both treatment costs and donor availability,” stated Professor Reuven Or, Director of the Department of Bone Marrow Transplantation and Cancer Immunotherapy at Hadassah Medical Center and the study’s Principal Investigator.

Zami Aberman, Chairman and CEO of Pluristem, added, “Improving the outcomes of bone marrow and umbilical cord blood transplantation can have a significant impact on the treatment of a range of diseases, from blood cancers to immune and genetic disorders. We are happy with the data from preclinical studies of PLX-R18 in the context of transplantation and look forward to continuing our work in these indications with both Hadassah Medical Center and Case Western University.”

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that in February it has enrolled 25 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). This follows January’s prior record. A total of 377 patients have been enrolled in the world’s largest Phase III study in head and neck cancer as of February 28, 2015.

“We are pleased to have achieved this consecutive month of record enrollment in 2015, particularly in light of the fact that February was a shorter month. During the month of February we also had a record number of patient screenings. During the month of February we also received clearance in the Philippines, Malaysia and Belarus to begin patient enrollment in those countries. This is expected to result in an even higher number of patients being enrolled in the study in March,” stated CEL-SCI Chief Executive Officer Geert Kersten.

The goal is to enroll a total of 880 patients through approximately 100 clinical centers in about 25 countries by the end of 2015.

About Multikine Phase III Study

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 improvement in the 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.