VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of July the Company enrolled 14 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). A total of 47 patients were enrolled over the past three months, with 14 in May, 19 in June, and 14 in July. This marks a 15% increase over the prior three month period when a total of 41 patients were enrolled.

“We reached an important milestone in July with total patient enrollment reaching 232, which is over one-quarter of the total 880 patients we expect to enroll by the end of 2015. We are on track with the pace of enrollment, which should accelerate in the fall based on the increasing number of clinical centers joining our study,” stated CEL-SCI Chief Executive Officer Geert Kersten. “In the past three months alone, we have received clearances to expand the trial into the United Kingdom, Austria, Sri Lanka, Turkey and France, while we also continue to add clinical sites in North America.”

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.

HAIFA, Israel, July 31, 2014 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that it has completed the approval process and received final clearance from a fifth regulatory agency for its 3D cell therapy manufacturing processes in use at its new facility in Haifa. The latest approval comes from Israel’s Ministry of Health and follows similar clearances from the U.S. Food and Drug Administration, the European Union’s Qualified Person, Germany’s Paul Ehrlich Institute, and the South Korean Ministry of Food and Drug Safety.

“This latest regulatory clearance further validates our proprietary cell manufacturing processes, which we believe are state-of-the-art and unmatched in the cell therapy arena. Our Haifa facility has the capacity to produce approximately 150,000 doses of PLX cells annually, with batch-to-batch consistency, which potentially translates into significant economic value,” stated Pluristem CEO Zami Aberman. “This latest approval also exemplifies our strategy of working with multiple regulatory bodies in order to establish Pluristem as a leading developer of cell therapies and to set the standards for this area of manufacturing,” added Aberman.

About Pluristem’s 3D Manufacturing

Pluristem’s state-of-the-art GMP manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which PLX cells can be manufactured in sufficient quantities to support late-phase clinical trials and commercial demand at time of regulatory approval. Pluristem manufactures its products in full compliance with the U.S. Food and Drug Administration (FDA) and European Medicines Agencies (EMA) current Good Manufacturing Practices (cGMP). Pluristem believes that control of the production process is critical for the successful manufacture of cell therapies and invests significantly in developing highly efficient, cutting-edge culturing systems for its range of PLX cell products.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that the French Agency for the Safety of Health Products has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in France. In the past three months CEL-SCI has also received governmental clearance to expand its trial into the United Kingdom, Austria, Sri Lanka and Turkey.

CEL-SCI’s Phase III trial is assessing the Company’s investigational immunotherapeutic agent Multikine as a potential first-line treatment for advanced primary head and neck cancer. 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 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.

About Multikine

Multikine* (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in a randomized, controlled, global 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 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 U.S. 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 clinically develop 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.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced that Turkey’s Ministry of Health has cleared the company to begin patient enrollment in CEL-SCI’s global pivotal Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection). The Company expects to enroll patients through three clinical centers in Turkey. Turkey thus becomes the 16th country to participate in the world’s largest Phase III head and neck cancer trial.

“As we add more countries and subsequently more clinical centers, we see an acceleration of the pace of the Phase III trial. In the most recently reported three month period, we saw a 93% increase in patient enrollment over the prior three month period,” stated CEL-SCI Chief Executive Officer Geert Kersten. “We are pleased with the progress of our clinical program as we investigate the efficacy of Multikine immunotherapy to treat cancer.”

Head and neck cancer accounts for about 6% of all cancers, with approximately 600,000 new cases reported annually worldwide. CEL-SCI has received U.S. Orphan Drug designation for Multikine in head and neck cancer in the US.

Further expansion of the Phase III trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers by the end of 2015. Over 220 patients have been enrolled in the study to date.

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 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.

Pompano Beach, Fla., July 14, 2014 (GLOBE NEWSWIRE) — DS Healthcare Group, Inc. (DSKX), a leading developer of personal care products and specialty pharmaceuticals, announced today that the first DS Laboratories store worldwide has opened in Shanghai, China in partnership with the Company’s Chinese distributor. The store exclusively features a complete line of DS Healthcare products including the Company’s clinically proven, industry-leading Spectral line of hair loss treatments and Revita hair stimulating shampoos and conditioners. The Company plans to open additional partnership stores worldwide in the coming months.

According to Euromonitor International, total sales of beauty and personal care products in China tripled in size from 2000 to reach an estimated $24 billion in 2010. Euromonitor projects the market will grow to $34 billion by 2015. Analysts credit China’s fast growing middle class for the rapid growth in sales.

“As we build the premier global brand in clinically proven personal care and Rx products, this retail store in Shanghai is an important component of our country-wide distribution and brand building strategy in China. We entered into a distribution agreement with our Chinese partner in September and it’s quickly become a very productive working relationship, as evidenced by the launch of this first DS Laboratories retail boutique. We are excited about the growth potential in this very important global market,” stated DS Healthcare President and CEO Daniel Khesin.

About DS Healthcare Group

DS Healthcare Group Inc. leads in the development of biotechnology for topical therapies. It markets through online and specialty retailers, distributors, cosmetics wholesalers, and salons. Its research has led to a highly innovative portfolio of personal care products and additional innovations in pharmaceutical projects. For more information on DS Healthcare Group’s flagship brand, visit www.dslaboratories.com

ROCKVILLE, Md.–(BUSINESS WIRE)–

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced an update in its Phase I multi-center dose-escalation study to evaluate the safety, tolerability, dose-limiting toxicities and maximum tolerated dose (MTD) of Supinoxin™ (RX-5902) in cancer patients with solid tumors.

Enrollment into four dose groups has been completed (25, 50, 100 and 150 mg) and no drug related adverse events have been reported. The fifth dose group (225 mg) is ongoing. The maximum tolerated dose of Supinoxin has not yet been achieved. Pharmacokinetic analysis has shown that Supinoxin displays dose-proportional exposure and an estimated oral bioavailability of 51%.

“With the fourth dosing group now complete, we continue to be encouraged by the pharmacokinetics and safety of Supinoxin in patients who have received multiple cycles of treatment. We are on schedule to complete enrollment of patients in this clinical trial by the end of 2014,” stated Rexahn’s Chief Executive Officer, Peter D. Suzdak, Ph.D. “We look forward to the data from this trial, which will further guide the clinical development of this compound.”

The Phase I trial of Supinoxin, which was initiated in August 2013, is a dose-escalation study designed to evaluate the safety, tolerability, dose-limiting toxicities and MTD in patients with solid cancer tumors that have previously failed treatment with approved therapies and shown progression of disease. Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. This trial is being conducted in three clinical oncology centers in the United States. Each patient has the ability to continue on the drug up to six cycles of treatment (a dosing cycle is defined as 3 weeks of drug treatment followed by 1 week off) if no disease progression is seen. Patients are assessed by CT or MRI prior to the start of therapy and after every two cycles of therapy to assess tumor progression. The trial is using an accelerated dose-escalation design: one patient is treated per dose cycle until a grade 2 related adverse event occurs then three patients will be treated per dose cycle. The decision to escalate dose is made by the data monitoring safety board (DMSB) after completion of one cycle of treatment based on safety and tolerability. Patients have the possibility to receive up to 6 cycles of treatment if the disease does not progress. Tumor biopsy samples are taken to assess the biomarker phospho-P68.

WILMINGTON, Mass., July 17, 2014 /PRNewswire/ — Implant Sciences Corporation (IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, today stated that it has shipped over $550,000 in previously unannounced orders of QS-H150 and QS-B220s to multiple customers in North America, Europe, Middle East, and Africa. Customers for the handheld and desktop explosives trace detectors include a major international logistics corporation, a construction company, an airport, and the embassy of a foreign nation. The systems will be used for building security and for the screening of air cargo, and airline passengers and baggage.

“The regulatory certifications we have received so far for our products have established a strong foothold for the Company in aviation security. Adding cargo, passenger, and baggage screening to our existing markets like building security, subways, and critical infrastructure has been an important part of our ability to significantly increase orders received as compared to the the previous year. We anticipate that success in the approval efforts we have underway at the moment will strongly accelerate this trend,” stated Implant Sciences’ Vice President of Sales and Marketing, Dr. Darryl Jones.

About the QS-H150 Handheld Explosives Trace Detector

The QS-H150 utilizes Ion Mobility Spectrometry (IMS) technology, providing fast, accurate detection of trace amounts of a wide variety of military, commercial, and homemade explosives. Built with no radioactive materials and featuring a low-maintenance, self-calibrating, and self-clearing design, the QS-H150 provides very high levels of operational availability. The QS-H150 has been proven to perform well in a wide variety of temperatures and challenging environments, from humid jungles to dry, sand swept deserts.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT:CVM) today announced that Sri Lanka’s Ministry of Health has cleared the Company to commence patient enrollment for its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Sri Lanka. This follows similar clearance to conduct the Phase III study in the UK and Austria during the past weeks. Further expansion of the trial is underway with a goal to have a total of 880 patients enrolled through about 100 clinical centers in 20 countries by the end of 2015.

CEL-SCI’s global pivotal Phase III clinical trial is the largest trial for head and neck cancer in the world. The trial, which already has over 220 patients enrolled, is assessing the Company’s investigational immunotherapeutic agent Multikine 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.

“If Multikine can be proven to harness the immune system against cancer, we believe this could offer a new modality for the treatment of head and neck cancer that could work in concert with the other methods — surgery, chemotherapy, and radiation therapy, used today for the treatment of this debilitating disease.” 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 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.

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) announced today that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant in the amount of $225,000 from the National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS), which is part of the National Institutes of Health (NIH). The grant will fund the further development of CEL-SCI’s LEAPS technology as a potential treatment for rheumatoid arthritis (RA), an autoimmune disease of the joints. According to Visiongain, the world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017.

The work will be conducted at Rush University Medical Center in Chicago, Illinois in the laboratories of Tibor Glant, MD, Ph.D., The Jorge O. Galante Professor of Orthopedic Surgery; Katalin Mikecz, MD, Ph.D. Professor of Orthopedic Surgery & Biochemistry; and Allison Finnegan, Ph.D. Professor of Medicine.

The NIH grant was awarded based on preliminary data by Dr. Glant’s team in collaboration with CEL-SCI showing that the administration of a proprietary peptide using CEL-SCI’s LEAPS technology prevented the development, and lessened the severity, including inflammation, of experimental RA when it was administered after the disease was induced in the animals. This data was presented in May 2013 by Daniel Zimmerman, Ph.D., CEL-SCI’s Senior Vice President of Research, Cellular Immunology, at the symposium on “Therapeutic Approaches to Autoimmunity” during the American Association of Immunologists (AAI) 100th annual meeting in Honolulu, Hawaii.

“These findings, in conjunction with the results from previously conducted studies with LEAPS vaccines in other RA models suggest that LEAPS vaccines may be used as a therapeutic treatment for different types of RA. LEAPS vaccines may be advantageous to other therapies because the LEAPS vaccines act early on the immune system and inhibit the production of disease-promoting inflammatory cytokines, unlike anti-Tumor necrosis factor alpha (TNFa) therapy which generally acts late and neutralizes only one individual inflammatory cytokine out of many involved in the disease process,” said CEL-SCI’s Dr. Zimmerman.

Dr. Zimmerman continued, “The successful conclusion of this round of studies in this autoimmune disease could take LEAPS closer to human studies and open its development to various other autoimmune diseases, such as multiple sclerosis, uveitis, colitis (Inflammatory Bowel disease) and certain types of diabetes.”

The NIH grant will fund studies in a well-established mouse model for Th1 Proteoglycan induced arthritis (PGIA) as developed by Drs. Glant and Mikecz and recently expanded to a Th17 PGIA by Drs. Finnegan and Glant. These two PGIA models are significant in that they more closely approximate human disease with the concurrent presence of rheumatoid factor and anti citrulline peptide antibodies and spondylitis that are not seen in most arthritis models.

About Rheumatoid Arthritis

Rheumatoid Arthritis is a chronic inflammatory disease that mainly targets the synovial membrane, cartilage and bone. It affects about 1% of the global population and is associated with significant morbidity and increased mortality. Anti-TNF related therapies are the current standard treatment of patients with advanced RA, but over half of the RA patients do not respond to current anti-TNF drugs such as etanercept (Enbrel®) and infliximab (Remicade®).

VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM), a late-stage oncology company, announced today that Daniel Zimmerman, Ph.D., its Senior Vice President of Research, Cellular Immunology, delivered a scientific presentation at the 12th Vaccines Research & Development: All Things Considered Conference in Boston, Massachusetts held on July 9-11, 2014.

The presentation entitled “The next generation of Rheumatoid Arthritis therapies: What has been learned from therapeutic vaccines for models of Rheumatoid Arthritis. Is IL-17 the real key to new therapies?” discussed the potential role CEL-SCI’s LEAPS vaccines might have on the future treatment of Rheumatoid Arthritis. The presentation centered on the theory that using LEAPS vaccines to treat a complex disease like Rheumatoid Arthritis can be beneficial because CEL-SCI’s vaccine can be synthesized to stimulate the appropriate immune response to treat the disease based on its immunodominant cytokine phenotype, which can be predetermined before treatment. The ability to customize the LEAPS treatment in this way offers clear benefits, as compared to using one therapeutic approach such as disease-modifying antirheumatic drugs (DMARDs) that are used today but are not universally applicable across all rheumatoid arthritis patients. The Company presented data which showed that LEAPS vaccines act at an earlier point in the progression of Rheumatoid Arthritis than any other therapy and with more specificity.

According to a survey conducted by Decision Resources, rheumatologists believe there is a high unmet need for Rheumatoid Arthritis therapies which induce remission in a greater percentage of Rheumatoid Arthritis patients than currently available agents. The world rheumatoid arthritis drug market will generate revenues of $38.5 billion in 2017, according to Visiongain.

The data presented included results from studies conducted at Rush University Medical Center in Chicago, Illinois in the laboratories of Tibor Glant, MD, Ph.D., The Jorge O. Galante Professor of Orthopedic Surgery; Katalin Mickecz, MD, Ph.D. Professor of Orthopedic Surgery & Biochemistry; and Allison Finnegan, Ph.D. Professor of Medicine. The presentation also drew on work published from others in related autoimmune conditions conducted in animal models and human studies that tested various treatments that are approved or still under investigation. These data supported CEL-SCI’s theory that vaccine therapies are more disease specific and act upstream, which are considered advantages, compared to current therapies.

“We have now shown and believe that LEAPS therapies that are tailored to either Th1 or Th17 in Rheumatoid Arthritis models should produce better results than therapies currently on the market, and we expect these findings would be similar in other models and human diseases including multiple sclerosis, uveitis and other autoimmune conditions. We believe that this helps explain why other therapies that are for Th1 signature conditions may not work with Th17 based approach and vice versa. As opposed to current therapies available or in development, LEAPS vaccines target the immune response well before the production of the signature cytokines and not after the cytokines have been produced and released in the inflammatory processes of autoimmune diseases. In our effort to better understand the significance of a T-cell signature cytokine phenotype, our analysis of other related publications indicated that either a Th1 or Th17 cytokine profile in four different animal autoimmune models were specifically induced and discussed for only that particular disease model. However the meanings for therapeutic interventions or overall significance in light of each other were not recognized,” stated Dr. Zimmerman.