Independent Case Study For Soligenix's CTCL Drug, SGX301, Drives Bullish Sentiment; Topline "FLASH" Trial Data Expected Q1 2020

Miami Beach, Florida--(Newsfile Corp. - February 20, 2020) - Soligenix may be nearing a transformative point in its history as data from its Phase 3 SGX301 (FLASH) trial to treat cutaneous T-cell lymphoma (CTCL) nears its release. The topline data from this late-stage study is expected in less than 40 days. And, if that release can validate data known from a recent case study performed by Dr. Brian Poligone, MD, Ph.D., then Soligenix (NASDAQ: SNGX) may earn the first of several potential catalysts that can drive shareholder value higher.

The Phase 3 clinical trial is targeting cutaneous T-cell lymphoma (CTCL) and is a double-blind, randomized, placebo-controlled study containing three 6-week treatment cycles. The study will conclude with roughly 169 patients getting treated, with top-line results from the double-blind treatment cycle 1, as noted, expected to get released before the end of the first quarter of 2020.

Beyond the benefit to the company, however, Soligenix, with SGX301 and other pipeline products, is aiming to bring to market treatments that target unmet medical needs for serious medical conditions. That distinction can place the company in an excellent position to attract partnerships and potentially earn FDA priority review status for some of its pipeline products. For the next 40 days, though, it's all eyes on SGX301.

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Finding The Positive In SGX301 Independent Case Study

Soligenix stock is surging since the beginning of the year, with shares higher by more than 100% as of Tuesday. Notably, the run in price appears justified by positive commentary for at least two of the company's late-stage Phase 3 trials, SGX301 and SGX942. Also, a recent case study was presented at the 4th World Congress for the company's CTCL drug, drawing interest to the drug's potential to become a front-line treatment against early stage CTCL. If that is the case, the drug will provide needed relief to patients and become a first to market "safe and effective" front-line therapy that may significantly reduce or clear the lesions associated with CTCL.

Soligenix, too, has provided shareholders with good reasons to be optimistic about the imminent SGX301 topline data. First, the company has had a productive interim analysis with favorable recommendation from the Independent Data Monitoring Committee (DMC). Second, in anticipation of positive results, Soligenix has beefed up its C-level team. And, third, the company has stated on several occasions that the company is adequately funded to get to top-line results in the two Phase 3 trials. Moreover, Soligenix has been extraordinarily transparent and timely for providing trial updates and is proving that the management has the skillset needed to navigate trials efficiently through each phase of a clinical study.

Most recently, Soligenix released an interview that highlights at least one of the trial investigator's opinions of SGX301. Needless to say, it's quite bullish about the drug's potential therapeutic value. The interview stems from a case study presentation made in February of this year and presented by Dr. Brian Poligone, the Director of the Rochester Skin Lymphoma Medical Group, in Fairfort, New York. And, not only does Dr. Poligone bring more than 15 years of experience in treating CTCL patients, it's important to note that as a "FLASH" trial investigator, he may have seen what others have not. Thus, when he speaks about SGX301, people listen.

SGX301 Presented at 4^th World Congress in February

Clearly, Dr. Poligone's bullish sentiment adds to the level of confidence for positive preliminary topline results. During a February 18th Zack's Research interview, several comments were made that contribute to a growing soundtrack of impressive feedback. Moreover, the level of confidence in his remarks leaves little room for ambivalent interpretation. From that interview, Dr. Poligone said,

• "The safety of SGX301, coupled with the long-term treatment effect was extremely impressive." [his response to a question about the patient case study results presented]

• "Our main goal is to get the disease to respond to therapy without introducing new risks or side effects to the patient."

• "It (SGX301) would be a front-line option for early-stage patients."

• "SGX301 could be an appropriate option to consider for a majority of my early-stage patients."

It's important to keep in mind that those comments came from a leading CTCL treatment provider. Further, Dr. Poligone is considered an authority on the topic of treating CTCL. Most important to his contribution, though, comes from his recently concluded case study of SGX301, where he managed a patient who has shown little to no therapeutic benefit from currently available drugs for the disease. In response to the lack of results from five prior therapies , he administered the SGX301 combination drug-light therapy to that patient and a robust response was achieved. He presented his findings at the 4th World Congress. And the presentation was decidedly favorable for the SGX301 profile. Back to that in a moment.

But, taking a step back, it's important to understand the effect mechanism, as well as why and how SGX301 can potentially demonstrate superiority compared to competitive products. As alluded to earlier, the current treatment of CTCL is plagued by significant challenges that bring substantial and frustrating shortcomings that can cause distress in patients and physicians alike. And, while cases can be different in scope, for most, Cutaneous T-cell lymphoma manifests as unsightly and often painful skin lesions that can affect up to 80% of the surface of the skin. It is relevant to note that although CTCL is not typically fatal, there is no curative treatment for the disease.

Moreover, current treatment options often have physicians not only treating the patient's lesions but also have them managing the side effects of CTCL medications, staying laser-focused on the potential chronic issues that these drugs can add. These conditions tend to arise in the later-stage treatment of the disease.

But, earlier stage treatments are also challenged and are mostly limited to topical nitrogen mustard, topical steroids, and damaging phototherapy. Topical treatments can be useful in reducing skin lesion size but will almost certainly result in a disease relapse r.

Additional types of topical medications can provide short term relief at best, but most are known to cause significant skin irritation, sometimes resulting in patient non-compliance in completing treatment. In contrast, it's believed that SGX301 has the most tolerant safety profile and from the patient case study presented, may require bout a 12-week treatment process.

Finally, although narrow-band phototherapy can prove useful in treating larger surface areas during the early stages of the disease, the practice still carries a chance of relapse along with a significantly increased risk of secondary skin cancer. This scant combination of available treatments and their debilitating side effects only works to stress the importance of discovering safer and more tolerable full-body skin-directed therapies, and SGX301 is showing the potential to become a practical option for many potential candidates.

Now, back to why the case study is important.

How And Why Is SGX301 Better?

Digging into the February case study presented by Dr. Poligone, Soligenix and its investors may have been offered a glimpse of what success of the Phase 3 SGX301 could look like. And, many speculate that the results of that case study could be the precursor to near-term positive data news.

In the independent case study, SGX301 had shown notable promise, separating itself from other treatments in both efficacy and its safety profile. The results can be compared to other marketed CTCL treatment drugs, and the result would stand - SGX301 is appreciably better.

Moreover, because CTCL can be especially challenging to treat in the early stages due to site delivery limitations, the effectiveness of traditional front-line solutions gets diluted. But, the primary challenge is the lack of front-line therapies and the concerning safety profiles of the therapies currently used for prolonged treatment with lesion recurrence.

Additionally, these competing therapies must be administered for many years and commonly result in chronic damage to the skin. SGX301, in contrast, both the treatment duration and safety profile of the combination therapy of SGX301 may ultimately lead the drug to emerge as a best-in-class CTCL treatment option. Here's why:

Specifically, the case presented by Dr. Poligone, SGX301 was used to treat a patient with FMF (folliculotropic mycosis fungoides), a highly resistant type of CTCL, who had previously failed to respond to topical, oral, and phototherapeutic treatments and medications. This patient was a participant in the company's Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial, receiving at least 12 weeks of SGX301 treatment and experiencing significant improvement , eventually leading to complete clearance of disease that's been sustained for about four-years. Is that patient an anomaly? Most think not, mainly because CTCL is far less forgiving than allowing for a complete clearance diagnosis. And, there is an equal argument that if topline results mimic the case study, SGX301 has the potential to become an extremely important drug in the battle to effectively treat CTCL.

SGX301 Therapy Sounds Complex, But Its Success Lay In Its Simplicity

Simply put, SGX301 is a photodynamic therapy with a non-UV light, a part of the combined technology that does not bring the increased risk of secondary skin cancers that are associated with UV treatments. And, unlike traditional UVA and UVB phototherapy, the SGX301 does not appear to increase the long-term risk of secondary skin cancers as it does not cause genetic mutation.

Starting the treatment process is simple. The first step involves the patient applying the ointment to their lesions at home the day before an expected doctor's visit, a procedure that allows the hypericin to be preferentially absorbed by the malignant T-cells. The next day, the patient visits the doctor's office and sits or stands in front of a proprietary, safe, fluorescent light device where the lesions get exposed to a specific wavelength of light for an average of 5-7 minutes. This combination of ointment application and light exposure constitutes a single treatment.

The treatment course in the company's Phase 3 trial is characterized by two of these treatments per week for a minimum of 6 weeks. Notably, patient retention in the trial appears to be high, which is a good indicator of potential safety and efficacy. But, it is an even more significant asset to those who are at higher risk to the side effects of traditional phototherapy due to preexisting conditions. And, as the management of CTCL is a process that will likely continue throughout the rest of a patient's life, the availability of a treatment that minimizes its disruptive characteristics without causing any side effects of its own is critical in attracting patients and physician attention.

More Positive Clues Support The Case Study

Although the interim "FLASH" trial data is blinded to Soligenix, several "read between the line" clues from the Data Monitoring Committee (DMC) may inspire confidence that the therapeutic benefit of SGX301 is favorable. Why? Because the Phase 3 trial was designed as an adaptive study, meaning that it included an interim analysis to potentially mitigate risk when extrapolating data from the smaller Phase 2 trial. But, as the trial continued, the unblinded DMC is privileged to review the actual trial data at a particular time point and make recommendations, such as adjustments in sample size, to maintain the pre-defined rigorous 90% statistical power.

The read-between-the-lines moment became more significant after the DMC made the recommendation to enroll additional subjects in the trial, implying to observers that they saw a promising drug effect with the treatment. Notably, the DMC had the power at that same time to stop the trial due to futility, especially if the drug could not meet the 90% statistical threshold with re-sizing. It did none of those things. Instead, many believe that the recommendation was a muted endorsement of interim results, otherwise, exposing new subjects to the treatment would be an unnecessary and perhaps unethical medical choice. They didn't do that, either.

Getting Ready For Planned Approval

Soligenix has reiterated that topline data from the SGX301 trial is expected to get released this quarter. Ahead of the completed study, the company has strengthened its commercial and business expertise at both the Board and senior management levels to begin to position the company for expedited growth upon successful Phase 3 results.

Also, Soligenix has alluded to several strategic options for the commercialization of approved drugs, including prospective marketing and development partnerships. Additionally, strategic alternatives available to the company may include mergers, acquisitions, and co-development and/or co-commercialization licensing agreements. And, with the drug's potential to become a front-line option for caregivers, the $250 million per year worldwide market potential is an attractive incentive to companies looking to secure a long-term revenue stream.

Now, with what appears to be a strong performance in the case study, the Phase 3 "FLASH" trial nears its ending stage and is expected to be completed within the first quarter of 2020. Even though the final results from treatment cycle 1 are yet to be released, the currently understood safety profile of SGX301 may, in and of itself, provide physicians with a safe front-line treatment of CTCL.

Moving Higher On Confidence?

Notably, the SNGX stock is up over 100% since January as investors anxiously await the final results of the company's clinical trials - creating an argument that the current market valuation of the company remains well below the potential created by an effective, well-tolerated treatment for cutaneous T-cell lymphoma. As the results for SGX301's Phase 3 trial get closer to the planned release date, investors may want to keep a close eye on the trends and trade volume activity in the stock. Both convey a message.

And, despite the roughly 100% gain in share price, a Zack's research analyst still believes the stock to be massively undervalued and has set his 12-month price target at $8.00 per share, which represents a more than 195% increase in share price from current levels.

Clearly, these are exciting times for CTCL patients, their providers, and for Soligenix. And, with the SGX301 "FLASH" trial being just the first of a potential catalyst filled spring season for the company, the safest bet may be to invest in this company from the long side of the trade. Too many good things can happen, and the timeline for those events is imminent. Usually, investors do well to follow the money, and in this case, investors are bullish on the company prospects.

Media Contact:
Kenny Ellis
Soulstring Media Group
ken@soulstringmedia.com

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