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).

VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) today announced that it has signed a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for CEL-SCI’s investigational immunotherapy drug Multikine (“Leucocyte Interleukin Inj.”) in HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI has also recently entered a Cooperative Research and Development Agreement (CRADA) for this disease indication with the US Naval Medical Center, San Diego.

Anal and genital warts are commonly associated with the Human Papilloma Virus, the most common sexually transmitted disease. Men and women with a history of anogenital warts have a 30-fold increased risk of anal cancer. Persistent HPV infection in the anal region is thought to be responsible for up to 80% of anal cancers. HPV is a significant health problem in the HIV infected population because, although they live longer as a result of greatly improved HIV treatments, their immune systems remain compromised.

Geert Kersten, Chief Executive Officer of CEL-SCI said, “We believe that if the data from the studies in HIV/HPV co-infected men and women with anal warts meet our expectations, this may represent a shorter clinical development route for Multikine which could possibly enable the submission of a marketing application before completion of our ongoing Phase III clinical trial for head and neck cancer. The addition of Ergomed as a committed co-development partner to the combined efforts of CEL-SCI and the US Navy will be extremely helpful and will potentially save us a lot of time during the clinical development process.”
Miroslav Reljanovic, Chief Executive of Ergomed added, “We took over patient recruitment of CEL-SCI’s Multikine Phase III head and neck cancer study in April of this year and are now in the process of rapidly expanding the study to meet its recruitment goals. At a recent investigator meeting we met with many enthusiastic investigators who are planning to join this trial and we are on track to meet the study’s enrollment goals. In the process of working on this Phase III study we have gained a level of comfort with Multikine that leads us to broaden our co-development collaboration, for the second time in two weeks, with CEL-SCI into this new unmet medical need indication.”

Under the terms of this new agreement, Ergomed will assume 50% (up to $3 million) of the clinical and regulatory costs for the development of Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. The full co-development program for Multikine must be jointly agreed to prior to implementation. Ergomed already has two similar co-development agreements for up to $13 million with CEL-SCI for the ongoing head and neck cancer Phase III clinical trial and HIV/HPV co-infected women with cervical dysplasia. Ergomed will receive its return on investment based on an agreed single digit percentage of any net income received by CEL-SCI for Multikine from product sales and/or certain partner milestone payments.

Multikine will be given to HIV/HPV co-infected men and women with peri-anal warts because promising early results were seen in another Institutional Review Board approved Multikine Phase I study conducted at the University of Maryland. In this study, Multikine was given to HIV/HPV co-infected women with cervical dysplasia resulting in visual and histological evidence of clearance of lesions. Furthermore, elimination of a number of HPV strains was determined by in situ polymerase chain reaction (PCR) performed on tissue biopsy collected before and after Multikine treatment. As reported by the study investigators, the study volunteers all appeared to tolerate the treatment with no reported serious adverse events.

VIENNA, Va.–(BUSINESS WIRE)– CEL-SCI Corporation (NYSE MKT:CVM) announced today it has held the Investigator Meeting for the European clinical investigators participating in the ongoing Phase III clinical trial of CEL-SCI’s investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Inj.). The meeting had 108 participants from 56 clinical centers that are or will be participating in the Multikine Phase III clinical trial for head and neck cancer. These clinical centers come from 13 European countries. The Investigator Meeting for the clinical centers in the United States and Canada is scheduled for November 2013. A total of approximately 880 patients are expected to be enrolled in this international Phase III study.

The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. About 6% of all cancers are head and neck cancer with an estimated 650,000 new cases globally and about 150,000 in the U.S. and Europe. The objective of the study is to demonstrate a statistically significant 10% improvement in overall survival of enrolled patients who are treated with the investigational therapy Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.

Should Multikine treatment plus SOC prove to be successful in demonstrating a statistically significant overall survival advantage in the Phase III study, and following the FDA review of the totality of the Multikine development program, Multikine plus the current standard of care treatment, following an anticipated marketing approval from the FDA, could then become part of the new standard of care treatment in this indication. That would represent a multi billion dollar market. The U.S. Food and Drug Administration (FDA) has already granted orphan drug designation to Multikine in the treatment of advanced primary head and neck cancer.

These Investigator Meetings are required since the number of clinical investigators involved in this Phase III trial under the new management of Ergomed and Aptiv Solutions has increased substantially. At these meetings critical discussions surrounding protocol, regulatory issues, enrollment criteria, procedures and safety issues, among other topics, are discussed, which are all very important to the success of the trial.

CEL-SCI, through the newly hired Clinical Research Organizations (CROs) Ergomed and Aptiv Solutions, is currently in the process of adding a large number of clinical centers in countries where regulatory approval has already been received to start the Multikine Phase III clinical trial as well as in new countries around the world, with an emphasis on the United States and Europe. The centers are being added to accelerate the enrollment in the clinical trial. These new centers are in addition to the existing study centers and the clinical centers being run in Israel and Taiwan where Teva Pharmaceuticals and Orient Europharma are partners in the Phase III clinical trial.

CEL-SCI recently announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. It has also announced that it entered into a co-development agreement with Ergomed to further develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV.

About Multikine
CEL-SCI’s lead investigational therapy Multikine, is 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 our 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 immune system to fight tumors.

VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) today announced that it has signed a co-development and profit sharing agreement with Ergomed Clinical Research Ltd. for CEL-SCI’s investigational immunotherapy drug Multikine (“Leucocyte Interleukin Inj.”) in HIV/HPV co-infected women with cervical dysplasia. Human Papilloma Virus (HPV) is the most common sexually transmitted disease. HPV is a significant health problem in the HIV infected population as individuals are living longer as a result of greatly improved HIV medications. People living with HIV and others with compromised immunity are more at risk for HPV-related complications. Persistent HPV infection can also be a precursor to cervical cancer.

Under the terms of this agreement, Ergomed will assume 50% (up to $3 million) of the clinical and regulatory costs for the development of Multikine as a potential treatment for HIV/HPV co-infected women with cervical dysplasia. The full co-development program for Multikine must be jointly agreed to prior to implementation. Ergomed already has a similar co-development agreement for up to $10 million with CEL-SCI for the ongoing head and neck cancer Phase III clinical trial. Ergomed will receive its return on investment based on an agreed single digit percentage of any net income received by CEL-SCI for Multikine from sales in this and the head and neck cancer indications.

Miroslav Reljanovic, Chief Executive of Ergomed said, “We took over the largest part of CEL-SCI’s Multikine Phase III head and neck cancer study in April of this year and are now in the process of rapidly expanding the study to meet its recruitment goals. In the process of working on this Phase III study we have gained a level of comfort with Multikine that leads us to broaden our co-development collaboration with CEL-SCI into this new indication.”

Geert Kersten, Chief Executive of CEL-SCI said, “As the Phase III trial in head and neck cancer is now gaining momentum under the new guidance of Ergomed and another CRO, we are able to expand our Multikine development program to cover other unmet medical needs. HPV infection in immune-compromised HIV infected patients is clearly one of those areas in need of new treatments.”

The co-development program aims to follow up on the early results seen in a Phase I study, conducted at the University of Maryland, where the investigational therapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia. In this study, investigational therapy Multikine was given to HIV/HPV co-infected women with cervical dysplasia resulting in visual and histological evidence of clearance of lesions. Furthermore, elimination of a number of HPV strains was determined by in situ polymerase chain reaction (PCR) performed on tissue biopsy collected before and after Multikine treatment. As reported by the study investigators, the study volunteers all appeared to tolerate the treatment with no reported serious adverse events associated with the Multikine treatment.

Cervical Intraepithelial Neoplasia (CIN) in HIV/HPV co-infected women:

Genital HPV infection is the most common sexually transmitted disease in both men and women. Usually, HPV infection does not cause overt signs or symptoms of disease, but some types of HPV cause cervical and anal intraepithelial neoplasia, or anal warts. Generally, HPV can be eliminated by an individual having a healthy immune system without treatment. However, certain HPV strains may cause persistent infection, which can lead to cancer. This is particularly evident in immune-compromised individuals, such as those who are HIV infected. Men and women who have HIV are therefore at a higher risk of developing these types of cancers, which include cancers of the cervix, vulva, vagina, penis and anus. Persistent HPV infection has been linked to development of cervical intraepithelial dysplasia/neoplasia (CIN) and high-grade CIN may become the precursor of cervical cancer.

About Multikine

Multikine, is an investigational immunotherapeutic agent that is currently being tested in a global 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. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on 3 continents around the world. The treatment with Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients. HPV has also been shown to be related to some head and neck cancers.

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