By: AllPennyStocks.com News

Monday, January 7, 2013

Biotechnology stocks are known to make a climb before key milestones. Leading into the start of clinical trials, albeit first, second or third phase, is certainly a time to climb as well as just before results are released as investors place bets on positive data being disclosed. In the case of Soligenex Inc. (OTCBB:SNGX), the stock has been on a climb for six months as good news has been steadily pouring out of the company related to oral BDP (oral beclomethasone 17,21-dipropionate) and its pipeline. Money has come to Soligenex from multiple channels to support oral B developments, including a $600,000 Small Business Innovation Research (SBIR) grant for its OrbeShield treatment for gastrointestinal acute radiation syndrome (GI ARS); another $300,000 National Cancer Institute SBIR grant to support a Phase II clinical trial for orBec a treatment for the gastrointestinal manifestation of chronic Graft-versus-Host disease; and a $521,000 non-dilutive financing via the State of New Jersey’s Technology Business Tax Certificate Transfer Program. The financing in December pushed Soligenex’s cash resources to about $3.3 million. Not too shabby for a developmental biotech.

On the regulatory pathway, the company has been brimming with news as well. The Princeton, New Jersey-based business said in August that results from a Phase 1B trial investigating an aluminum hydroxide (Alum) adjuvanted formulation of RiVax™ is safe and well tolerated, and induces greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax™. $940,000 in grant money from the Office of Orphan Products Development of the Food and Drug Administration helped support the trials.

That news was promptly followed by the FDA clearing the companies Investigational New Drug application for SGX203 for the induction treatment of pediatric Crohn's disease. Soligenix is developing the treatment under an Orphan Drug Designation from the FDA. In November, the FDA also granted Soligenex “Fast Track” status for SGX203 as a new drug candidate for the indication.

Speaking of Crohn’s disease, Soligenix regained North American and European commercial rights to oral BDP through an amendment of its Collaboration and Supply Agreement with Sigma-Tau Pharmaceuticals, Inc. for the topical corticosteroid. BDP has been marketed for decades as an active ingredient in nasal spray and inhalers, but Soligenex’s oral version is the subject of several issued and pending patents across the globe. All tallied, oral BDP is the subject of four orphan drug designations by the FDA, including pediatric Crohn’s disease.

On the first trading day of 2013, the company reported that the FDA granted Orphan Drug status to OrbeShield for the prevention of death following a potentially lethal dose of total body irradiation (TBI) during or after a radiation disaster. As previously mentioned, OrbeShield, with Oral BDP as its active ingredient, is being developed for GI ARS, a leading cause of early death following high doses of TBI.

Friday, the company followed that news by saying that the FDA has cleared its IND to initiate clinical trials OrbeShield for the mitigation of morbidity and mortality associated with the GI ARS.

Shares were trading as low as 23 cents each in mid-2012, but the influx of developments helped the stock price to coast upward to a 52-week high of 77 cents in November. A modest retrace followed to a low of 55 cents in December, but last week’s news has the stock on the climb again; rising to 71 cents on Friday to close out the week, Monday’s trading has so far been muted with the stock price stuck in neutral at 71 cents as well.

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