Soligenix, Inc. (SNGX) is a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense. Their 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 their novel innate defense regulator technology (SGX942) for the treatment of oral mucositis.
SNGX’s Vaccines/BioDefense business segment includes active development programs for RiVax™, their ricin toxin vaccine candidate, VeloThrax™, their anthrax vaccine candidate, OrbeShield™, their GI acute radiation syndrome therapeutic candidate and SGX101 and SGX943, their melioidosis therapeutic candidates. The development of their vaccine programs incorporates the use of their 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) focused on the joint development of SGX101 for the treatment for melioidosis.
It is interesting to note that the largest shareholder of Intrexon, which has nearly a $3.5B market cap, is Third Security, LLC who owns more than 60% of Intrexon. Upon visiting the Third Security, LLC website, www.thirdsecurity.com you will find that Randal J. Kirk is the CEO of the fund and Mr. Kirk is also the CEO of Intrexon. Note that R.J. Kirk’s investment in Intrexon, which engineers living cells into drug factories, has been a been a significant winner for his portfolio. Kirk took it public in 2013 and it moved up sharply to the tune of +50% in its first day of trading. Kirk’s stake alone is worth more than $1 billion. Kirk previously sold his drug company, Clinical Data, to Forest Laboratories for $1.2 billion in 2011, and prior that he sold New River Pharmaceutical to Shire for $2.6 billion in 2007. He is currently ranked #183 on the Forbes 400 List. Mr.Kirk’s beneficial ownership position is approximately 26% of Soligenix. In addition, Paolo Cavazza’s beneficial ownership position on his own behalf and on behalf of Sigma-Tau is approximately 14% of Soligenix. Sigma-Tau, founded in 1957 by Claudio Cavazza is amongst the global leaders in therapeutics for rare diseases. Having two distinguished investors in biotech significantly invested in SNGX is encouraging.
Recently, SNGX 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.
Note that 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.
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.
Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix stated, ”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. 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. 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.”
To learn more about Soligenix, Inc. (SNGX) please visit the Vista Partners’ Soligenix, Inc. page at the following link or go to www.vistapglobal.com where one can find a dedicated company page that includes the latest company and industry news, videos, links to SEC filings, a a recently updated FREE Research Report with a Price target of $7.
SNGX shares are currently trading at $1.61, which is approximately a 60% increase since the beginning of the year.
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The post Late Stage Biotech Soligenix (SNGX) Trial For Treatment of Oral Mucositis in Head & Neck Cancer Patients Progresses/Gets Positive Recommendation to Enroll 20 More Subjects appeared first on Vista Partners.