Long-term Positive Data Reported from Phase II SGX942 and Top-line Data for SGX301 Expected in First Half 2018
BEND, OR / ACCESSWIRE / August 2, 2017 / On July 27th, Soligenix (NASDAQ: SNGX) announced the beginning of patient enrollment for its Phase 3 trial for SGX942. The trial, named "DOM–INNATE" (Dusquetide treatment in Oral Mucositis - by modulating INNATE immunity), is testing SGX942 (dusquetide) in severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (CRT). The company received US Food and Drug Administration (FDA) clearance for the trial protocol earlier this year. Oral mucositis refers to erythematous and ulcerative lesions of the oral mucosa observed in patients with cancer being treated with chemotherapy, and/or with radiation therapy to fields involving the oral cavity. Lesions of oral mucositis are often very painful and compromise nutrition and oral hygiene as well as increase risk for local and systemic infection. Mucositis can also involve other areas of the alimentary tract; for example, gastrointestinal (GI) mucositis can manifest as diarrhea. Thus, mucositis is a highly significant and sometimes dose-limiting complication of cancer therapy. Head and neck cancer being treated with chemotherapy, and/or with radiation therapy, causes >80% of patients to develop oral mucositis, a severe side effect of these treatments. The Phase 3 trial of SGX942 is set up in a manner to allow for high statistical power from a relatively small patient group. SGX942 is a non-invasive treatment and this factor combined with the relatively small number of patients the FDA agreed to be included in this trial should allow for enrollment to be swift. In many instances, companies can get hung up in late stage trials with enrollment issues and we do not see this being a problem for this Phase 3 trial. Should SGX942 show the ability to reduce or eliminate this awful side effect of chemotherapy, and/or with radiation therapy to fields involving the oral cavity, SGX942 may pave the way for better chemotherapy treatment which is of tremendous value to patients for obvious reasons.
SGX942 could be used in other tumor types where mucositis is also a dose-limiting toxicity. The Phase 3 "DOM-INNATE" trial is designed as a double-blind, placebo-controlled study with the same treatment regimen as the Phase 2 study. It differs in that it has a larger planned enrollment (approximately 190 patients, compared with 111 patients in the Phase 2 trial), and will have treatment centers in multiple countries. The trial will enroll subjects with squamous cell carcinoma of the oral cavity and oropharynx who are scheduled to receive a minimum total cumulative radiation dose of 55 Gy fractionated as 2.0-2.2 Gy per day with concomitant cisplatin chemotherapy given as a dose of 80-100 mg/m2 every third week.
The trial randomizes patients into two arms, receiving either SGX942 or placebo given twice a week and for two weeks following completion of chemotherapy and radiation therapy (CRT). The primary endpoint for the study will be the median duration of severe oral mucositis, which will be assessed by oral examination at each treatment visit and then through six weeks following completion of CRT. Oral mucositis will be evaluated using the WHO Grading system. Severe oral mucositis is defined as a WHO Grade of ≥3. Subjects will be followed for an additional 12 months after the completion of treatment.
The commencement of enrollment for the SGX942 Phase 3 trial in oral mucositis is a major milestone in the company's history. Assuming a successful outcome of the Phase 3 study, Soligenix would possess the only immune modulating drug that prevents a dose-limiting toxicity caused by many common cancer therapies. If this trial replicates the results seen in the Phase 2 study, the company may have a $50OM+ treatment option. Soligenix now has two active Phase 3 trials operational which would seemingly lead one to think the company may be worth hundreds of millions if not a billion dollars, yet Soligenix trades at a highly discounted (in our view) market cap of only $13M, yes you read that correctly. In addition to these Phase 3 trials both being operational, Soligenix's RiVax® anti-ricin vaccine received $2M in additional funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, bringing the total amount awarded to date under this contract to $18.7M. If all contract options are exercised, the total award of up to $24.7 million will support the preclinical, manufacturing and clinical development activities necessary to advance heat stable RiVax® with the FDA. As the company makes information available on the progress of its Phase III program in CTCL, the DOM-INNATE trial for oral mucositis, both of which have Fast Track designation, and the BioDefense program we believe the value of the company may increase and potentially increase significantly.
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SOURCE: Sylva International LLC
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