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.

DES MOINES, IA–(Marketwired – Oct 16, 2013) – The SpendSmart Payments Company (PINKSHEETS: SSPC), a provider of prepaid payment programs, announced today it has agreed to acquire SMS Masterminds (“SMS Masterminds”), an innovator in the rapidly growing mobile marketing industry. SMS Masterminds provides SMS-based Mobile Loyalty Solutions primarily to small and medium sized businesses, addressing a worldwide mobile advertising market forecast to reach $11.3 billion in 2014, according to eMarketer.
SMS Masterminds’ multiple revenue streams include mobile commerce services, an excellent strategic fit for SpendSmart in the payments space. SMS Masterminds also has installed loyalty tablets at retail locations across the U.S., with plans to expand their nationwide rollout significantly in 2014. SpendSmart will leverage SMS Masterminds’ retail merchant network to promote existing and new prepaid card programs. The combined entities will also be positioned to market its portfolio of prepaid card solutions to the 1.2 million customers currently signed up for SMS Masterminds’ mobile loyalty programs.SMS Masterminds has been profitable every year since inception. In 2013, its first year of eligibility, SMS Masterminds ranked No. 731 on the 2013 Inc. 500|5000 list of fastest growing companies in America and ranked No. 66 on the list of Top Software Companies on the Inc. 500|5000.

“As mobile’s share of advertising budgets, customer relationship management, and e-commerce continues to grow, mobile has become a critical channel coupling marketing and payments for goods and services. This acquisition completes our ability to deliver a suite of products, services and marketing channels to both sides of the payments cycle — cardholders and merchants. It inherently points to a significant opportunity for SpendSmart where mobile marketing, loyalty and payment solutions intersect,” stated Bill Hernandez, President of The SpendSmart Payments Company. “We see an excellent long term opportunity where SpendSmart can be a key segment player in mobile marketing, loyalty and commerce. In the immediate and near term, we believe there are a broad range of benefits to our Company as a result of this acquisition including high-margin recurring revenues and the opportunity to offer our SpendSmart cards to SMS Masterminds’ 1.2 million subscribers as well as driving additional in-store sales and customer loyalty for SMS merchants.”

SMS Masterminds’ CEO Alex Minicucci commented, “We have profitably grown SMS Masterminds to a point where our company is ready to broaden our offering and our reach. As part of The SpendSmart Payments Company, we are creating synergies that we believe will further accelerate our growth rate. Mobile marketing is evolving into mobile commerce, which inherently calls for the integration of payment systems. Our entire team is very excited to capitalize on new market opportunities as part of The SpendSmart Payments Company.”

The closing of the asset purchase agreement is contingent upon the customary closing conditions, including, but not limited to the completion of due diligence.
For further information on the acquisition, please refer to the Company’s Form 8K filed with the Securities and Exchange Commission.

For more information, please visit: www.spendsmartcard.com

About The SpendSmart Payments Company

The SpendSmart Payments Company, Inc. (PINKSHEETS: 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.

Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage biopharmaceutical company, announced today that it has signed an exclusive license agreement with the Ohio State Innovation Foundation, an affiliate of The Ohio State University, for a novel oligonucleotide drug delivery platform, Lipid-Coated Albumin Nanoparticle (LCAN), developed at The Ohio State University College of Pharmacy. In preclinical studies, the LCAN platform has demonstrated the ability to deliver oligonucleotide compounds into cancer tumors, which can result in improved safety and efficacy. Rexahn’s first preclinical candidate to be developed with this delivery platform will be RX-0201-nano.

“The LCAN platform allows Rexahn to specifically target cancer tumors with oligonucleotides in a way that increases potency and reduces side effects, and is a broad platform that has the ability to generate multiple therapeutic candidates going forward. We will initially move forward with RX-0201-nano as the first candidate from the LCAN platform, and we anticipate entering the clinic with the first candidate within two years,” stated Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer. “Furthermore, the platform also offers Rexahn the ability to use this delivery platform to enhance and create additional next generation oligonucleotide therapies.”

LCAN incorporates both cationic lipid and a cationized albumin that can form an electrostatic complex with oligonucleotides and be co-encapsulated by lipids. It also has a targeting moiety conjugated on the surface to direct the LCAN directly to the cancer tumors. RX-0201-nano is a nanoliposomal Akt1 inhibitor, similar to the Company’s Archexin® which may be effective in solid tumors and hematological malignancies and has shown high efficiency and good stability in preclinical studies.

Robert J. Lee, Ph.D., researcher at The Ohio State University College of Pharmacy and the inventor of the LCAN technology, commented, “The LCAN platform represents a significant advancement in targeted delivery of oligonucleotides to cancer tumors. Other types of formulation approaches have been tried in the past but none offered such potent activity for the targeted delivery of an oligonucleotide to the cancer tumor.”

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing best-in-class therapeutics for the treatment of cancer. Rexahn currently has three clinical stage oncology candidates, Archexin®, RX-3117, and RX-5902 and a robust pipeline of preclinical compounds to treat multiple types of cancer. Rexahn has also developed proprietary drug discovery platform technologies in the areas of Nano-Polymer-Drug Conjugate Systems (NPDCS), nano-medicines, 3D-GOLD, and TIMES. For more information, please visit www.rexahn.com.

About The Ohio State University College of Pharmacy

Established in 1885, The Ohio State University College of Pharmacy is a leader in pharmaceutical education, research and clinical practice. As part of one of the most comprehensive health sciences campuses in the nation, the college is home to world-class faculty, dedicated researchers and top students who are leading the way in pharmacy education, practice and research. The college’s graduate programs are currently ranked 7th in the nation by U.S. News & World Report.

About The Ohio State University:

Ohio State is a dynamic community of diverse resources, where opportunity thrives and where individuals transform themselves and the world. Founded in 1870, The Ohio State University is a world-class public research university and the leading comprehensive teaching and research institution in the state of Ohio. With more than 63,000 students (including 57,000 in Columbus), the Wexner Medical Center, 14 colleges, 80 centers, and 175 majors, the university offers its students tremendous breadth and depth of opportunity in the liberal arts, the sciences, and the professions.

Implant Sciences Corporation (IMSC), a high technology supplier of systems and sensors for homeland security and defense markets, announced today that it has sold its TSA-approved QS-B220 explosives trace detector to The Delivery People for use in U.S. air cargo screening. The QS-B220 is the first explosives trace detector (ETD) system purchased by The Delivery People, a full service, asset-based transportation provider that is also a Certified Cargo Screening Facility (CCSF). Transportation and logistics companies with CCSF status are certified by the TSA to screen air cargo packages for explosives before they are loaded onto airplanes. CCSFs are required to use TSA-approved screening systems.

“The decision maker at The Delivery People was very familiar with ETDs. When compared with competing systems, based on a strong recommendation from a current customer, combined with the systems’ favorable ease of use and low total cost of ownership, they selected the QS-B220,” stated Implant Sciences’ Vice President of Sales and Marketing, Dr. Darryl Jones. “Customer adoption rates for the QS-B220 have significantly increased over the past quarter and we look forward to continued sales momentum in the near future.”

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 January 2013, the Company became only the third ETD manufacturer, and the sole American-owned company, to currently have product approval 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 approval 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).

Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage biopharmaceutical company, announced today that it has signed an exclusive license agreement with the Ohio State Innovation Foundation, an affiliate of The Ohio State University, for a novel oligonucleotide drug delivery platform, Lipid-Coated Albumin Nanoparticle (LCAN), developed at The Ohio State University College of Pharmacy. In preclinical studies, the LCAN platform has demonstrated the ability to deliver oligonucleotide compounds into cancer tumors, which can result in improved safety and efficacy. Rexahn’s first preclinical candidate to be developed with this delivery platform will be RX-0201-nano.

“The LCAN platform allows Rexahn to specifically target cancer tumors with oligonucleotides in a way that increases potency and reduces side effects, and is a broad platform that has the ability to generate multiple therapeutic candidates going forward. We will initially move forward with RX-0201-nano as the first candidate from the LCAN platform, and we anticipate entering the clinic with the first candidate within two years,” stated Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer. “Furthermore, the platform also offers Rexahn the ability to use this delivery platform to enhance and create additional next generation oligonucleotide therapies.”

LCAN incorporates both cationic lipid and a cationized albumin that can form an electrostatic complex with oligonucleotides and be co-encapsulated by lipids. It also has a targeting moiety conjugated on the surface to direct the LCAN directly to the cancer tumors. RX-0201-nano is a nanoliposomal Akt1 inhibitor, similar to the Company’s Archexin® which may be effective in solid tumors and hematological malignancies and has shown high efficiency and good stability in preclinical studies.

Robert J. Lee, Ph.D., researcher at The Ohio State University College of Pharmacy and the inventor of the LCAN technology, commented, “The LCAN platform represents a significant advancement in targeted delivery of oligonucleotides to cancer tumors. Other types of formulation approaches have been tried in the past but none offered such potent activity for the targeted delivery of an oligonucleotide to the cancer tumor.”

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to developing best-in-class therapeutics for the treatment of cancer. Rexahn currently has three clinical stage oncology candidates, Archexin®, RX-3117, and RX-5902 and a robust pipeline of preclinical compounds to treat multiple types of cancer. Rexahn has also developed proprietary drug discovery platform technologies in the areas of Nano-Polymer-Drug Conjugate Systems (NPDCS), nano-medicines, 3D-GOLD, and TIMES. For more information, please visit www.rexahn.com.

About The Ohio State University College of Pharmacy

Established in 1885, The Ohio State University College of Pharmacy is a leader in pharmaceutical education, research and clinical practice. As part of one of the most comprehensive health sciences campuses in the nation, the college is home to world-class faculty, dedicated researchers and top students who are leading the way in pharmacy education, practice and research. The college’s graduate programs are currently ranked 7th in the nation by U.S. News & World Report.

About The Ohio State University:

Ohio State is a dynamic community of diverse resources, where opportunity thrives and where individuals transform themselves and the world. Founded in 1870, The Ohio State University is a world-class public research university and the leading comprehensive teaching and research institution in the state of Ohio. With more than 63,000 students (including 57,000 in Columbus), the Wexner Medical Center, 14 colleges, 80 centers, and 175 majors, the university offers its students tremendous breadth and depth of opportunity in the liberal arts, the sciences, and the professions.

Rexahn Pharmaceuticals Announces Publication of Preclinical Data for Novel Anti-Cancer Compound RX-3117