Media

JERUSALEM, November 12, 2013 /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 that the last patient has left the clinic from its U.S. FDA Phase 2a safety study for ORMD-0801, an oral insulin capsule based on the Company’s platform Protein Oral Delivery (POD™) technology.

The Phase 2a trial, which enlisted 30 type 2 diabetes patients in an in-clinic setting for a seven-day period, was implemented in response to FDA feedback requesting a safety study on ORMD-0801 prior to initiating a larger multi-center trial in the US.

“We are thrilled to announce the last patient out of our Phase 2a clinical trial under the FDA. We look forward to announcing the results,” said Oramed CEO Nadav Kidron.

About ORMD-0801 Oral Insulin

Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream. For more information on ORMD-0801, the content of which is not part of this press release, please visit http://oramed.com/index.php?page=14

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), with trials on healthy volunteers (Phase 1b) and T2DM patients (Phase 2a) underway. Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.

For more information, the content of which is not part of this press release, please visit http://www.oramed.com

WILMINGTON, Mass., Nov. 6, 2013 /PRNewswire/ — Implant Sciences Corporation (OTCQB: IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, announced today it has sold multiple units of its QS-H150 handheld explosives trace detectors to a customer in China. The units will be deployed across several locations for the purpose of protecting nuclear power plants in multi-layered security environments.

“We’ve been selling our QS-H150s in China since 2005, and during that time they have earned a well-deserved reputation for superior performance. QS-H150s are trusted for use in the most mission-critical settings,” stated Implant Sciences’ Vice President of Sales and Marketing, Darryl Jones. “In the past Implant Sciences has provided QS-H150s for nuclear power plant protection in other countries such as Japan and Spain. We are pleased to announce this sale which marks the first such deployment in China.”

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.

About Implant Sciences

Implant Sciences is the leader in next generation Explosives Trace Detection (ETD) technology. In October 2013, the Company became the third ETD manufacturer, and the sole American-owned company, to currently have product qualification from the US Transportation Security Administration. Implant Sciences has developed proprietary technologies used in its commercial explosives and drugs trace detection systems, which ship to a growing number of locations domestically and internationally. Implant Sciences’ QS-H150 handheld explosives trace detector has received Qualified Anti-Terrorism Technology Designation and, in addition to receiving TSA qualification for air cargo screening, the Company’s QS-B220 has also received STAC certification and a Developmental Testing & Evaluation (DT&E) Designation by the U.S. Department of Homeland Security under the Support Anti-terrorism by Fostering Effective Technology Act of 2002 (the SAFETY Act). For further details on the Company and its products, please visit the Company’s website at www.implantsciences.com.

WILMINGTON, Mass., Nov. 5, 2013 /PRNewswire/ — Implant Sciences Corporation (OTCQB:IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, announced today that its QS-B220 explosives trace detectors have been sold to a federal agency in charge of operating 19 airports in one Latin American country. The units will be used for checkpoint screening and air cargo screening.

“With this deployment, our QS-B220 has become the system of choice in explosives trace detection devices for these 19 airports. This is a major milestone for Implant Sciences and gives the Company a significant presence in the Latin American aviation security market,” stated Implant Sciences’ Vice President of Sales and Marketing, Dr. Darryl Jones. “The QS-B220 was selected based on its favorable total cost of ownership, superior performance capabilities, and its regulatory certifications.”

About the QS-B220 Desktop Explosives Trace Detector

The QS-B220 uses Ion Mobility Spectrometry (IMS) to rapidly detect and identify trace amounts of a wide variety of military, commercial, and homemade explosives. With significantly lower maintenance requirements than competing systems, the QS-B220 can be deployed for a much lower total cost of ownership than other approved products. Featuring a radioactive material-free design, push-button maintenance and diagnostics, and a patented inCal™ internal automatic calibration system, the QS-B220 brings new levels of performance and convenience to desktop trace detection users with unsurpassed ease of use.

About Implant Sciences

Implant Sciences is the leader in next generation Explosives Trace Detection (ETD) technology. In October 2013, the Company became the third ETD manufacturer, and the sole American-owned company, to currently have product qualification from the US Transportation Security Administration. Implant Sciences has developed proprietary technologies used in its commercial explosives and drugs trace detection systems, which ship to a growing number of locations domestically and internationally. Implant Sciences’ QS-H150 handheld explosives trace detector has received Qualified Anti-Terrorism Technology Designation and, in addition to receiving TSA qualification for air cargo screening, the Company’s QS-B220 has also received a Developmental Testing & Evaluation (DT&E) Designation by the U.S. Department of Homeland Security under the Support Anti-terrorism by Fostering Effective Technology Act of 2002 (the SAFETY Act). For further details on the Company and its products, please visit the Company’s website at www.implantsciences.com.

HAIFA, Israel, Nov. 4, 2013 (GLOBE NEWSWIRE) — Pluristem Therapeutics Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, announced today that its PLacental eXpanded (PLX) cells proved to be safe in an animal study assessing maternal and fetal toxicity. The study was conducted at the Charles River Laboratories, one of the world’s leading contract research organizations. The results showed that the intramuscular administration of PLX-PAD cells to pregnant rats did not result in any maternal or fetal toxicity. Pluristem will pursue the clinical development of PLX-PAD cells for the indication of preeclampsia based on these results and earlier evidence that the cells were efficacious in preeclamptic animal models.

“Pluristem is extremely pleased with the demonstrated safety of our PLX-PAD cells in pre-clinical models of pregnancy,” said Zami Aberman, Chairman and CEO of Pluristem. “This study, together with the work performed by Dr. Brett Mitchell from Texas A&M College of Medicine,suggesting that our PLX-PAD cells are efficacious in preeclamptic animal models, is an important milestone towards our goal of initiating clinical trials for preeclampsia.”

In the study, forty-four pregnant female rats were injected intramuscularly with either PLX-PAD at a dosage of 10 million cells (n=22) or cell-free placebo (n=22), on gestational day 13. Throughout the study the pregnant animals were monitored for viability status, body weight and food consumption. On gestational day 21, female rats were examined for ovarian and uterine contents and abnormalities in dams and pups. Charles River’s report concluded that the IM injection of PLX-PAD cells in pregnant rats did not result in any maternal or fetal developmental toxicity.

About Preeclampsia

Preeclampsia is one of the most common medical complications of pregnancy, and one of the leading causes of premature births, stillbirths and early neonatal and maternal deaths. If left untreated, it can progress to eclampsia, the life-threatening occurrence of seizures during pregnancy. The only known treatment for preeclampsia is abortion or delivery. The disease occurs in previously healthy women after their 20th week of pregnancy, and signs include high blood pressure and significant amounts of protein in the urine. According to the World Health Organization, preeclampsia occurs in approximately 6–8% of pregnancies worldwide. It is estimated that preeclampsia costs the global health care system $3 billion annually.

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 expansion 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.

VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) announced today that a second interim review of the safety data from its open label, randomized, controlled, pivotal Phase III study of Multikine* (Leukocyte Interleukin, Injection) investigational new drug immunotherapy was conducted by an Independent Data Monitoring Committee (IDMC). The IDMC said that the data raised no safety concerns, and recommended that the Phase III study continue unmodified.

CEL-SCI considers the results of the IDMC review to be important since studies have shown that up to 30% of Phase III trials fail due to safety considerations. The IDMC’s safety findings from this interim review were similar to those reported by investigators during CEL-SCI’s Phase I-II trials. IDMC interim reviews are a standard part of clinical trial protocol. Ultimately, the decision as to whether a drug is safe is made by the FDA based on an assessment of all of the data from a trial.

IDMCs are committees commonly used by sponsors of clinical trials to protect the interests of the patients in ongoing trials especially when the trials involve patients with life threatening diseases, and when, as in cancer clinical trials, they extend over long periods of time. The CEL-SCI IDMC includes prominent physicians and scientists from major institutions in the USA and abroad who are key opinion leaders in head and neck cancer and who are knowledgeable in all of the disciplines related to CEL-SCI’s study, including statistics.

Following the First Safety review by the IDMC for this study, which stated that there were no safety concerns, CEL-SCI has doubled its efforts to expand the study to many more clinical sites in the US and Europe in order to increase the accrual rate to the study. CEL-SCI terminated Inventiv Clinical and in its place engaged Aptiv Solutions, a US-based clinical research organization (CRO) and Ergomed, a European-based CRO, to help in securing clinical sites and increasing the number of subjects accrued to the study. CEL-SCI recently filed an arbitration claim against Inventiv alleging (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud, seeking at least $50 million in damages.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on three continents around the world. The objective of the study is to demonstrate a statistically significant 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. The universally accepted current standard of care for the patient population being enrolled in the CEL-SCI study is surgery plus radiation or surgery plus concurrent radiation and chemotherapy, dependent on the risk factors for recurrence found after surgery. Multikine treated patients receive 15 local injections of Multikine over a 3 week period prior to standard of care treatment. Multikine injections are administered in the area around the tumor and in the area of the adjacent lymphnodes since those two areas are where the tumor is most likely to recur. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.

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 for use following completion of our clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that employs our body’s natural ability to fight tumors.

WILMINGTON, Mass., Oct. 31, 2013 /PRNewswire/ — Implant Sciences Corporation (OTCQB:IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, announced today that it will exhibit its QS-B220 desktop explosives and drugs trace detectors at Air Cargo Americas on November 6th through 8th in Miami, Florida at booth #929.

Implant Sciences’ QS-B220 has recently been added to the “Qualified” section of the Air Cargo Screening Technology List (ACSTL), joining the list of products from which the TSA encourages regulated customers to purchase. Carriers and freight forwarders now have the option of deploying a screening technology that is free from radioactive materials and emits no ionizing radiation.

Only equipment listed on the ACSTL can be used for screening cargo carried on passenger planes landing or taking off from American airports. Additionally, many other countries accept TSA qualification when making purchase decisions.

“Air Cargo Americas is a great venue for us to highlight our QS-B220. Our system is recognized in the air cargo screening field as the new standard in trace detection,” stated Todd Swearingen, General Manager, Americas for Implant Sciences. “A number of prospective buyers have heard from our current users that the QS-B220 is technologically superior to the competition. We look forward to demonstrating the product’s competitive advantages to buyers throughout the Americas.”

“This is a critical and exciting time for Implant Sciences. The QS-B220 has achieved a string of regulatory successes so far this year, and our systems have built a reputation for being easy-to-use and low-cost to maintain. We believe that an investment in trade shows and exhibitions this fall will help us capitalize on this momentum and increase our market share,” stated Implant Sciences’ President and CEO, Glenn D. Bolduc.

The 2011, Air Cargo Americas International Congress and Exhibition was the largest air cargo exhibition in the Western Hemisphere, with 6,903 international aviation and maritime business executives from 65 countries visiting the exhibition. According to Air Cargo Americas, at the Air Cargo & Sea Cargo Americas 2011 exhibition, more than $101 million in actual and projected sales were reported by exhibitors.

About the QS-B220 Desktop Explosives Trace Detector

The QS-B220 uses Ion Mobility Spectrometry (IMS) to rapidly detect and identify trace amounts of a wide variety of military, commercial, and homemade explosives. With significantly lower maintenance requirements than competing systems, the QS-B220 can be deployed for a much lower total cost of ownership than other approved products. Featuring a radioactive material-free design, push-button maintenance and diagnostics, and a patented inCal™ internal automatic calibration system, the QS-B220 brings new levels of performance and convenience to desktop trace detection users with unsurpassed ease of use.

About Implant Sciences

Implant Sciences is the leader in next generation Explosives Trace Detection (ETD) technology. In October 2013, the Company became the third ETD manufacturer, and the sole American-owned company, to currently have product qualification from the US Transportation Security Administration. Implant Sciences has developed proprietary technologies used in its commercial explosives and drugs trace detection systems, which ship to a growing number of locations domestically and internationally. Implant Sciences’ QS-H150 handheld explosives trace detector has received Qualified Anti-Terrorism Technology Designation and, in addition to receiving TSA qualification for air cargo screening, the Company’s QS-B220 has also received a Developmental Testing & Evaluation (DT&E) Designation by the U.S. Department of Homeland Security under the Support Anti-terrorism by Fostering Effective Technology Act of 2002 (the SAFETY Act). For further details on the Company and its products, please visit the Company’s website at www.implantsciences.com.

WILMINGTON, Mass., Oct. 28, 2013 /PRNewswire/ — Implant Sciences Corporation (IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, announced today that the U.S. Transportation Security Administration (TSA) has notified the Company that its QS-B220 Explosives Trace Detector has been granted acceptance onto the “Qualified” section of the Air Cargo Screening Technology List (ACSTL). With this acceptance, which is a follow-on to the “Approved” status granted by the TSA in January 2013, the QS-B220 joins the list of products from which regulated parties are encouraged to purchase security solutions. Further information regarding the TSA’s notification can be found in the Company’s Current Report on Form 8-K, which will be filed with the Securities and Exchange Commission on October 28, 2013.

Implant Sciences’ Vice President of Technology, Todd Silvestri commented, “This is the fourth regulatory success Implant Sciences has had with the QS-B220 this year. What is significant about this result, as well as the STAC certification we announced earlier this month, is that both require testing conducted under actual operating conditions. Through these government approvals and successes with a number of air cargo customers, the QS-B220 has proven its efficacy in air cargo screening facilities was well as in the laboratory.”

Implant Sciences’ President and CEO Glenn D. Bolduc added, “Implant Sciences is proud to be the only provider of a TSA-Qualified trace detection solution that does not incorporate radioactive materials. Not having to invest in radiation safety protocols represents a significant operational advantage for many of our customers. We anticipate that this achievement will accelerate our sales efforts, both domestically and internationally.”

About the QS-B220 Desktop Explosives Trace Detector

The QS-B220 uses Ion Mobility Spectrometry (IMS) to rapidly detect and identify trace amounts of a wide variety of military, commercial, and homemade explosives. With significantly lower maintenance requirements than competing systems, the QS-B220 can be deployed for a much lower total cost of ownership than other approved products. Featuring a radioactive material-free design, push-button maintenance and diagnostics, and a patented inCal™ internal automatic calibration system, the QS-B220 brings new levels of performance and convenience to desktop trace detection users with unsurpassed ease of use.

About Implant Sciences

Implant Sciences is the leader in next generation Explosives Trace Detection (ETD) technology. In October 2013, the Company became the third ETD manufacturer, and the sole American-owned company, to currently have product qualification from the US Transportation Security Administration. Implant Sciences has developed proprietary technologies used in its commercial explosives and drugs trace detection systems, which ship to a growing number of locations domestically and internationally. Implant Sciences’ QS-H150 handheld explosives trace detector has received Qualified Anti-Terrorism Technology Designation and, in addition to receiving TSA qualification for air cargo screening, the Company’s QS-B220 has also received a Developmental Testing & Evaluation (DT&E) Designation by the U.S. Department of Homeland Security under the Support Anti-terrorism by Fostering Effective Technology Act of 2002 (the SAFETY Act). For further details on the Company and its products, please visit the Company’s website at www.implantsciences.com.

DES MOINES, IA–(Marketwired – Oct 29, 2013) – The SpendSmart Payments Company (OTCQB: SSPC), a provider of prepaid payment programs, announced today it has teamed with DECA, a high school and college campus-based organization that prepares emerging leaders and entrepreneurs in marketing, finance and management. DECA will promote the SpendSmart™ Prepaid MasterCard® and its mobile and web consumer-facing platform to its members, as well as offer the SpendSmart™ Prepaid MasterCard® as a travel solution for the 10,000 students who go to DECA’s regional and national contests each year.
The SpendSmart™ Prepaid MasterCard® supports DECA’s mission as an educational organization for teens and young adults. DECA will earn marketing fees for each new card issued to a DECA member to help support local fundraising for their membership.

DECA’s High School Division includes 190,000 members in 3,500 schools and its Collegiate Division includes over 15,000 members in 200 colleges and universities.
John Fistolera, Assistant Executive Director of Corporate & External Affairs for DECA commented, “This strategic partnership with SpendSmart is a great fit for DECA on many levels. Our members will benefit from SpendSmart’s financial education programs and also have the opportunity to apply these concepts directly through use of the SpendSmart™ Prepaid MasterCard® when they travel to our events.”

“We believe the ‘Award Winning’ SpendSmart™ Prepaid MasterCard®’s features and benefits support DECA’s mission of preparing emerging entrepreneurs and business leaders for their future careers. We are pleased to partner with DECA and offer them a way to generate marketing income to help support their organization’s mission, while also supporting financial education and literacy,” stated The SpendSmart Payments Company CEO Mike McCoy. “We look to build similar partnerships with other educational institutions to make a greater number of young people and their families aware of the benefits that the SpendSmart™ Prepaid MasterCard® offers.”

For more information, please visit: www.spendsmartcard.com and www.deca.org

About DECA

DECA is a 501(c)(3) non-profit student organization that prepares emerging leaders and entrepreneurs in marketing, finance, hospitality and management. With over a 60 year history, DECA has impacted the lives of more than ten million students, educators, school administrators and business professionals since it was founded in 1946. Their strong connection with DECA has resonated into a brand that people identify as a remarkable experience in the preparation of emerging leaders and entrepreneurs. DECA’s programs and activities have constantly evolved as the organization uses the latest technology and applies cutting edge educational research.

About The SpendSmart Payments Company

The SpendSmart Payments Company, Inc. (OTCQB: SSPC) is making money smarter. The Company is expanding its prepaid debit card services from issuing its own cards to select user demographic segments, to the providing SpendSmart Program Manager services to third-party card issuers. The Company’s primary product, the SpendSmart Prepaid MasterCard for teens, offers resources to families with teens who want to learn responsible spending habits. The SpendSmart card provides its users with modern methods of developing financial literacy, centered around a card solution for parents who aim to guide their teens in making sensible, economic choices. The card helps open the lines of communication between parent and teen by tracking spending in real time and, ultimately, creates teachable moments around smart spending habits. For more information, please explore www.spendsmartcard.com.

Pompano Beach, Oct. 29, 2013 (GLOBE NEWSWIRE) — DS Healthcare Group, Inc. (DSKX), a leading developer of personal care products, today announced it has filed a patent application titled, “Compositions and Methods for Treatment of Hair Loss,” with the United Stated Patent and Trademark Office. The patent application addresses DS Healthcare’s proprietary formulations that stimulate hair growth and reduce hair loss in men and women through treatments delivered topically.

“We believe there is tremendous unmet demand for an effective prescription grade hair loss treatment. Although a few other prescription products have been launched for this indication in the past decades, they have either been less effective than users would prefer, or have been coupled been side effects that most users have found to be unacceptable,” stated DS Healthcare President and CEO Daniel Khesin. “Having already generated millions of dollars providing over-the-counter shampoos and other topical hair growth products, we know this market and we believe our proprietary prescription-grade formulation holds promise for the millions of people looking to preserve their hair growth.”

About DS Healthcare Group

DS Healthcare Group Inc. leads in the development of biotechnology for topical, and nutritional therapies. It markets through online and specialty retailers, distributors, cosmetics wholesalers, and salons. Its brands include DS Laboratories (www.DSLaboratories.com), Sigma Skin (www.SigmaSkin.com), Polaris Research Laboratories (www.PolarisReserachLabs.com) and The Pure Guild (www.ThePureGuild.com).