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Ricin Toxin Vaccine Poster Presented at the 2015 ASM Biodefense and Emerging Diseases Research Meeting in Washington, DC
Published: Feb 13, 2015 7:00 a.m. ET
Heat Stable Ricin Toxin Vaccine Elicits Strong Immune Responses and Protects Animals from Ricin Intoxication
PRINCETON, N.J., Feb. 13, 2015 /PRNewswire/ -- Soligenix, Inc. (otcqb:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today that it presented data from its recent preclinical study that demonstrated the efficacy and safety of its heat-stabilized ricin toxin vaccine (RiVax™) in a non-human primate (NHP) lethal aerosolized ricin exposure model. The data was presented in a poster session at the American Society of Microbiology (ASM) Biodefense and Emerging Diseases Research meeting on Wednesday, February 11, 2015 at Washington Marriott Wardman Park, 2660 Woodley Rd. NW in Washington, DC.
Soligenix has been developing RiVax™, its proprietary ricin toxin vaccine, in conjunction with its heat stabilization technology, ThermoVax™, as a heat-stable biodefense vaccine. Vaccination with RiVax™ protected all animals from acute lethal death due to aerosolized ricin exposure, in contrast to unvaccinated animals that died within 40 hours.
In the study, 12 animals were vaccinated with RiVax™ and 6 animals were given an injection of placebo (unvaccinated control). Each animal received 3 intramuscular injections, administered at time 0, 30 days and 60 days. Vaccination with RiVax™ was well tolerated with no evidence of elevated heart rate, respiration or temperature. All RiVax™-vaccinated animals generated neutralizing antibodies after the third injection. To fully test the efficacy of the vaccine, all animals were exposed to an aerosol of ricin toxin 3-5 times the amount that is known to result in death of untreated animals. All RiVax™-vaccinated animals survived exposure, while all unvaccinated control animals died within 40 hours, demonstrating a statistically significant (p<0.0001) improvement in survival. Moreover, the lungs of the RiVax™-vaccinated animals did not demonstrate any signs of irreversible damage, unlike those of the unvaccinated control animals.
"The improvement in both survival and morbidity with the use of this well-tolerated vaccine is a significant step forward in the development of RiVax™ for emergency preparedness use", stated Oreola Donini, PhD, Senior Vice President and Chief Scientific Officer of Soligenix. "Previous studies with RiVax™ have demonstrated significantly enhanced thermostability indicating that cold chain storage will potentially not be required for this vaccine, enabling it to be stored and distributed at room temperature. RiVax™ is currently the subject of a preclinical and clinical development contract awarded by the National Institute of Allergy and Infectious Diseases (NIAID) and worth up to $24.7 million over 6 years."
About Ricin Toxin
Ricin toxin is a plant toxin thought to be a bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin comes in many forms like powder, mist, pill, or pellet. Ricin can also be dissolved in water and other liquids. As a poison, ricin is so potent that the US Centers for Disease Control (CDC) estimates the lethal dose in humans is about the size of a grain of salt. Exposure to ricin results in local tissue necrosis and general organ failure leading to death within several days of exposure, and is especially toxic when inhaled. Ricin is a ribosome inactivating protein (RIP) and a potent member of the AB family of toxins. The enzymatic ricin toxin A subunit (RTA) is an RNA-N-glycosidase which cleaves a specific adenine residue with eukaryotic 28S ribosomal RNA, leading to protein synthesis arrest and cell death.
There are currently no effective means to prevent the effects of ricin poisoning. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack.
About RiVax™
RiVax™ is our proprietary vaccine candidate being developed to protect against exposure to ricin toxin, and if approved would be the first ricin vaccine. RiVax™ has demonstrated statistically significant (p < 0.0001) preclinical survival results in a lethal aerosol exposure non-human primate model, and has also been shown to be well tolerated and immunogenic in two Phase 1 clinical trials in healthy volunteers. A Phase 1A clinical trial was conducted with a formulation of RiVax™ that did not contain an adjuvant. This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers. The adjuvant-free formulation of RiVax™ induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals. To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax™ was formulated with an adjuvant of aluminum salts (known colloquially as Alum) for a Phase 1B clinical trial. Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants. The results of the Phase 1B study indicated that Alum-adjuvanted RiVax™ was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. In preclinical animal studies, the Alum formulation of RiVax™ also induced higher titers and longer lasting antibodies than the adjuvant-free vaccine.
The development of RiVax™ has been sponsored through a series of grants from both NIAID and the US Food and Drug Administration (FDA), which were awarded to Soligenix and to Dr. Ellen Vitetta and colleagues at the University of Texas Southwestern (UTSW) where the vaccine originated. Most recently, Soligenix was awarded a contract valued at up to $24.7 million by the US Department of Health and Human Service's National Institutes of Health (NIH) (specifically funded by the National Institute of Allergy and Infectious Diseases or NIAID) to advance the development of Soligenix's thermostabilization technology, ThermoVax™, combined with the company's ricin toxin vaccine, Rivax™ as a medical countermeasure (MCM) to prevent the effects of ricin exposure.
RiVax™ has been granted orphan drug designation by the FDA for the prevention of ricin intoxication.
About ThermoVax™
ThermoVax™ is a technology that is designed to eliminate the standard cold chain production, distribution and storage logistics required for most vaccines. Cold chain requirements add considerable cost to the production and storage of current conventional vaccines. According to the Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with a total value of $20.6 billion) require shipment through cold chain. Elimination of the cold chain would also enhance the utility of these vaccines for emerging markets and for other applications requiring but lacking reliable cold chain capabilities. Further, the World Health Organization (WHO) reports that as much as 50% of all global vaccine doses are wasted because they are not kept within required temperature ranges. NIAID has also highlighted the priority of technologies for biodefense vaccines that focus on broad spectrum approaches including vaccine adjuvants and temperature stabilization for long shelf life, rapid onset of immunity, and surge capacity for production. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, the utilization of ThermoVax™ has the potential to facilitate easier storage and distribution of Strategic National Stockpile vaccines in emergency situations.
The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations. RiVax™ is extremely labile in liquid form requiring careful management under refrigerated conditions at 4 degrees Celsius (39 degrees Fahrenheit). By employing ThermoVax™ during their final formulation, it is possible to produce stable and potent vaccines that are capable of withstanding temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year.
The underlying technology has been developed by Drs. John Carpenter and Theodore Randolph at the University of Colorado. The vaccine technology has been developed to date in collaboration with SRI International, the University of Kansas, the Wadsworth Center of the New York State Department of Health, and the Tulane National Primate Research Center under the sponsorship of the cooperative grant from NIAID.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation XON, +2.75% focused on the joint development of SGX101 for the treatment for melioidosis.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/...shington-dc-300033001.html
SOURCE Soligenix, Inc.
Copyright (C) 2015 PR Newswire. All rights reserved
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Soligenix Inc (OTCBB:SNGX) Continues Its Recovery
by Georgi Kamburov February 16, 2015
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On December 19 the stock of Soligenix Inc (OTCBB:SNGX, SNGX message board) crashed hard wiping close to 30% of its price, closing at $0.95 and posting its new 52-week low of $0.91. The sharp decline was caused by the announcement of a registered public offering of 1.8 million units at a price of $1.21 per unit. The issuance of more shares and the fact that the units were priced below the market price at the time of $1.35 left investors quite disappointed.
Since then, however, SNGX has been steadily recovering its losses. Last Thursday the ticker surged by more than 12% and climbed to a close at $1.37. On that day over 1 million shares changed hands, a near-record volume for the company. The positive performance continued during Friday’s trading with SNGX adding another 6.5% to its value and closing the week at $1.46. Although the daily volume was less than half of the one from the previous session it was still nearly 4 times higher than the 30-day average.
It seems that investors are reconsidering the initial negative reaction from last year and are now showing considerable support for the company. It is true that SNGX has a lot to offer when compared to a significant portion of the other pharmaceutical pennystocks. The financial report for the quarter ending September 30, 2014, showed that back then the company had:
• $4.2 million cash
• $5.7 million total current assets
• $10.5 million total current liabilities
• $2.7 million revenue
• $4.3 million net loss
The amount of the reported liabilities is alarming but it should be noted that $7.4 million of them consist of warrant liability.
With the money acquired through the public offering SNGX plans to fund the Phase III clinical study of its SGX301 drug for the treatment of cutaneous T-cell lymphoma. The study is scheduled to begin in the first half of 2015. At the same time the SGX942 drug is currently in Phase II clinical trial with data expected to be presented by the end of the next quarter.
SNGX has also received around $57 million in government contracts for the development of their vaccine candidates. Last Friday the company announced positive results from the preclinical study of their heat-stabilized ricin toxin vaccine (RiVax). The Rivax is the subject of a contract worth up to $24.7 million over the period of 6 years awarded to the company by the National Institute of Allergy and Infectious Diseases (NIAID).
Despite its appeal investors must not forget that the risks around SNGX remain significant. The company is still far away from having a product approved for commercialization and it may need more external financing in order to move forward with its planned clinical trials. That is why any position in the stock should be attempted only after doing extensive research and careful planning.
8th Aug 2013, 3:04 pm by Fiona MacDonald
Soligenix itself just closed financing worth a little over $7.1 million in a public offering of common stock and warrants in order to advance its candidates; in that instance too the renowned billionaire life sciences investor had a role to play, in that a chunk of the funds originated with a firm linked to Kirk himself. Soligenix itself just closed financing worth a little over $7.1 million in a public offering of common stock and warrants in order to advance its candidates; in that instance too the renowned billionaire life sciences investor had a role to play, in that a chunk of the funds originated with a firm linked to Kirk himself.
Market watchers noted another victory for billionaire Randal Kirk Thursday, as his company Intrexon (NYSE:XON) made its debut in New York and was immediately propelled into the top per cent of performers on the exchange on the back of a rise in value of more than 50 per cent.
The synthetic biology company raised $160 million from the 10 million shares offered for sale in the IPO, with each share selling for $16, a price at the high end of the expected range. Shares in the day’s hottest IPO immediately took flight, putting on another $8.06 by 2:18 pm EST for a valuation that corresponds to the company being worth in excess of $2 billion.
For Kirk, who already made a fortune from New River and Clinical Data and has – by virtue of his 100 million shares in the newly IPO’d market darling -- just made another one, it is only the latest episode in a storied and glittering career. Truly the industry legend knows a good bet when he sees one, making his interest in Soligenix (OTCBB:SNGX) all the more heartening for the New Jersey-based development stage biopharmaceutical company.
The company, which has already seen its stock rise almost 150 per cent in the calendar year so far, caught the renowned life sciences billionaire’s eye earlier this year with its development of a treatment for high priority government biothreat melioidosis, a contagion which has the potential for widespread dissemination through aerosol. The infectious disease is caused by a bacterium that is highly resistant to antibiotic regimens, with mortality rates as high as 40 per cent in parts of Southeast Asia. In May, the company signed an exclusive worldwide collaboration agreement with Intrexon, today’s market livening IPO subject, for the development of a treatment for the disease.
Soligenix itself just closed financing worth a little over $7.1 million in a public offering of common stock and warrants in order to advance its candidates; in that instance too, the renowned billionaire life sciences investor had a role to play, in that a chunk of the funds originated with a firm linked to Kirk himself.
Soligenix has numerous drug candidates under its belt including multiple programs targeting indications that each have at least $200 million plus of worldwide market potential.
Soligenix Announces Positive Recommendation by Data Review Committee on its Phase 2 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer Patients
Published: Mar 3, 2015 7:00 a.m. ET
Study to Enroll 20 More Subjects
PRINCETON, N.J., March 3, 2015 /PRNewswire/ -- Soligenix, Inc. (otcqb:SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today it has received a positive recommendation from the Data Review Committee (DRC) to continue enrolling into the company's Phase 2 study evaluating SGX942, a first-in-class innate defense regulator (IDR), as a treatment for oral mucositis in patients undergoing chemoradiation (CRT) therapy for head and neck cancer. Following DRC review of available data on the subjects enrolled in the trial, the committee recommended that enrollment include an additional 20 subjects randomized into either a single SGX942 dose group or the placebo group to allow for a more targeted assessment of the drug's potential effect and to inform final dose selection in this patient population.
This Phase 2 study is a randomized, double-blind, dose-ranging, placebo-controlled trial, initially set to enroll approximately 75 subjects across 3 SGX942 dose groups and placebo, focused on demonstrating the safety and biologic activity of SGX942 in patients with tumors of the mouth and oropharynx who often experience debilitating oral mucositis as a consequence of tumor treatment with CRT. The primary efficacy assessment is the comparison of the incidence and/or duration of both ulcerative and severe oral mucositis throughout the subjects' 7 week course of CRT and for an additional 4 weeks thereafter. The study blind will remain in effect until completion of the trial.
"This initial dose-ranging clinical trial was specifically designed to examine 3 dose levels of SGX942 versus placebo and, if statistically justified, to continue enrollment in any patient/dose groups in which there was promise of potentially demonstrating a positive and clinically-meaningful outcome," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "This positive recommendation from the DRC will allow for a sufficient number of subjects to be enrolled into the most promising dose group to increase the potential of demonstrating a positive effect with SGX942 on this catastrophic side-effect of cancer treatment that remains a significant unmet medical need."
Dr. Straube continued, "Given the additional subjects to be enrolled and our primary endpoint assessment through 11 weeks, timing to top-line results may move into the second half of this year."
About Oral Mucositis
Mucositis is the clinical term for damage done to the mucosa by anticancer therapies. It can occur in any mucosal region, but is most commonly associated with the mouth, followed by the small intestine. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of mucositis, that mucositis affects approximately 500,000 people in the US per year and occurs in 40% of patients receiving chemotherapy. Mucositis can be severely debilitating and can lead to infection, sepsis, the need for parenteral nutrition and narcotic analgesia. The gastrointestinal damage causes severe diarrhea. These symptoms can limit the doses and duration of cancer treatment, leading to sub-optimal treatment outcomes.
The mechanisms of mucositis have been extensively studied and have been recently linked to the interaction of chemotherapy and/or radiation therapy with the innate defense system. Bacterial infection of the ulcerative lesions is now regarded as a secondary consequence of dysregulated local inflammation triggered by therapy-induced cell death, rather than as the primary cause of the lesions.
It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of oral mucositis, that oral mucositis in head and neck cancer is a subpopulation of approximately 90,000 patients in the US, with a comparable number in Europe. Oral mucositis almost always occurs in patients with head and neck cancer treated with chemoradiation therapy (>80% incidence of severe mucositis) and is common (40-100% incidence) in patients undergoing high dose chemotherapy and hematopoietic cell transplantation, where the incidence and severity of oral mucositis depends greatly on the nature of the conditioning regimen used for myeloablation.
Oral mucositis in head and neck cancer remains an area of unmet medical need where there are currently no approved drug therapies.
About SGX942
SGX942 is an innate defense regulator (IDR), a new class of short, synthetic peptides that has a novel mechanism of action in that it has simultaneous anti-inflammatory and anti-infective activity. IDRs have no direct antibiotic activity but modulate host responses, increasing survival after infections with a broad range of bacterial Gram-negative and Gram-positive pathogens, as well as accelerating resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. SGX942 has demonstrated safety in a Phase 1 clinical study in healthy human volunteers and efficacy in numerous animal disease models including mucositis, colitis, skin infection and other bacterial infections. SGX942 and related analogs has a strong intellectual property position, including composition of matter. SGX942 was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada and approximately $40 million has been put towards its development to date, inclusive of government grants.
SGX942 has received fast track designation from the US Food and Drug Administration (FDA) for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients. Fast track is a designation that the FDA reserves for a drug intended to treat a serious or life-threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, Soligenix will be eligible to submit a new drug application (NDA) for SGX942 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Our BioTherapeutics business segment is developing SGX301 as a first-in-class photo-dynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201), and our novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
Our Vaccines/BioDefense business segment includes active development programs for RiVax™, our ricin toxin vaccine candidate, VeloThrax™, our anthrax vaccine candidate, OrbeShield™, our GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, our melioidosis therapeutic candidates. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax™. Currently, this business segment is supported with up to $57 million in government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). Additionally, Soligenix has an exclusive worldwide collaboration with Intrexon Corporation XON, +1.25% focused on the joint development of SGX101 for the treatment for melioidosis.
For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "intends," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats conducting preclinical and clinical trials of vaccines, obtaining regulatory approvals and manufacturing vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the US Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, Soligenix's reports on Forms 10-Q and 10-K. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/...er-patients-300044014.html
SOURCE Soligenix, Inc.
Copyright (C) 2015 PR Newswire. All rights reserved
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XON
+0.60 +1.25%
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