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Location is trivial as the European Medicines Agency is located in London (till March19)
Company sponsored excuse to visit family?
Nothing. The whole biotech sector has been tumbling this week, Anavex is no exception.
From 5 to 4 in 4 days...
It’s what they call “trying to get in cheaper”
Nice gesture, wished it had more substance.
Don’t know but i keep reading about “ our good doctor” has a plan. And I wonder too what it is. Based on past experience I am not expecting much.
Seems you are right
But it came as a complete surprise to Missling. So was the second attack.
Can we expect “our good doctor” to have learned a lesson? One would hope so!
Correction: the dump in Nov15 happened after CTAD, with AF and JF triggerhappy.
The run-up (or pump) happened on the uplisting coattail.
Of course it was pre-programmed but I keep reading that “our good doctor” has a plan. Well he did not on 2 previous occasions, despite his background.
If history is any indicator then we are in for a rollercoaster: there was no plan in Nov15 for the post CTAD attack and neither was there one in July16 after AAIC.
Ah the closing buy
Volume has been pathetic, hardly call it accumulation.
Have you told the BOD they made a mistake with Hoang? Will they fire him now too?
Any shareprice prediction?
Only Rett is a known fact, they pay 600k of the roughly 1 mil tab
ALzheimer and Parkinson have no publicly known external funding.
Rett and Alzheimer will start, pretty sure of that. Have my doubts about the Parkinson trial. Just gut-feeling
Finally PK/PD news, only had to wait 23,5 months since CTAD15.
13 waisted investor years
Given the multiple repeats that three trials will start in 2017, would it be acceptable to you if let’s say only one would start, or two out of three?
Double daily volume out of nowhere.
I blame nothing on nobody. I know that papers sometimes go back and forth a couple of times before they are accepted for publication.
The paper has been submitted to a scientific journal and is going through the peer review.
We all know that, Don’t we?
Most important sentence at the bottom:
Disclosure: We have no position in TPIV and have not been compensated for this article.
Nov15 turned into Nov17
Have you ever come across a pharmaceutical company who does not want to bring their drug to the market as quickly as possible??
These actions do not speak to the broader market and today is gigantic opportunity to fill a void with a new, fresh approach. Something different from the gazillionth trial time the same approach fails.
But we got more of the same: 375 shares and silence. I don’t think AXON’s tutes are picking up on the hints...
At this point, all we need is action. There has been too much silence.
Today was THE golden opportunity to highlight the difference with AXON.
It turns out to be a missed opportunity, although the day is not over yet...
Publication can go back and forth multiple times between peers and author(s)
Still plenty of interim data and data coming from the 3 phase2 trials that are currently running.
Perhaps the BOD got tired of all the whining on ihub?
At this stage it is welcome anytime as it is long overdue!
However we do know that the full phase1 data has been entered for peer review publication, so this is going through the motions.
Cracks me up!
Happy?
With renewed confidence into the future?
How about a status update on the MTA with BIIB to celebrate the one year anniversary? How about confirming that the deal is still alive or dead in the water?
P2 was n=32, and p3 will be at least n=300 according dr Misslinf. So at least peanuts times ten.
And and two other p2 trials running too...
As we almost enter Q4, still no additional milestone boxes can be ticked off...
I am intrigued by the timing: usually when an offering is done before an expected data release it means no good news.
However this is not the classical offering but again a warrant conversion with institutional holders.
Time will tell.
Soligenix Announces $1.5 Million NIDCR SBIR Grant Award Supporting the Pivotal Phase 3 Clinical Trial of SGX942 for the Treatment of Oral Mucositis in Head and Neck Cancer
Wed September 20, 2017 6:00 AM|PR Newswire|About: SNGX
PR Newswire
PRINCETON, N.J., Sept. 20, 2017 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH), has awarded Soligenix a Small Business Innovation Research (SBIR) grant of approximately $1.5 million over two years to support the conduct of its Phase 3, multinational, randomized, double-blind, placebo-controlled study evaluating SGX942 (dusquetide) as a treatment for severe oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (CRT).
"We are appreciative of the support provided by NIDCR for the previous Phase 2 clinical study and now for the recently initiated pivotal Phase 3 clinical study of SGX942 in the treatment of oral mucositis," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We believe this SBIR grant award further validates dusquetide's novel mechanism of action, as well as the positive clinical data generated to date. Oral mucositis remains an extremely debilitating side effect of cancer treatment and is particularly severe and prevalent in head and neck cancer patients. We look forward to completing the study to potentially demonstrate the clinical efficacy of SGX942."
Dr. Schaber continued, "With approximately $7.5 million in non-dilutive NIH funding awarded to Soligenix thus far in 2017 across our biotherapeutics and biodefense pipelines, we would like to thank NIH for its continued support and for its recognition of the merits of the important work we are doing in areas of unmet medical need."
Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy.
Based on the positive and previously published Phase 2 results (Study IDR-OM-01), the pivotal Phase 3 clinical trial (Study IDR-OM-02) is a highly powered, double-blind, randomized, placebo-controlled, multinational trial seeking to enroll approximately 190 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. Subjects will be randomized to receive either 1.5 mg/kg SGX942 or placebo given twice a week during and for two weeks following completion of CRT. The primary endpoint for the study is 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 is 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.
Soligenix is working with leading oncology centers to advance this Phase 3 clinical trial referred to as the "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity). The study design incorporates feedback from the US Food and Drug Administration (FDA) as well as from the European Medicines Agency (EMA) via the Scientific Advice process. The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study, if successful, in conjunction with results from the Phase 2 dose-ranging study, generally will be considered sufficient to support a marketing authorization application for potential licensure in Europe.
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 and is severe, causing inability to eat and/or drink, in >80% of patients. It 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
Dusquetide (the active ingredient in SGX942) is an innate defense regulator (IDR), a new class of short, synthetic peptides. It has a novel mechanism of action whereby it modulates the body's reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. IDRs have no direct antibiotic activity but, by modulating the host's innate immune system responses, increase survival after infections caused by a broad range of bacterial Gram-negative and Gram-positive pathogens. It also accelerates resolution of tissue damage following exposure to a variety of agents including bacterial pathogens, trauma and chemo- and/or radiation therapy. Preclinical efficacy and safety has been demonstrated in numerous animal disease models including mucositis, colitis, melioidosis, macrophage activation syndrome (MAS) and other bacterial infections. Some of these preclinical findings have been published in an article entitled "A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy," available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.03.032.
SGX942 has demonstrated safety in a Phase 1 clinical study in 84 healthy human volunteers. Recently, SGX942 had positive results in an exploratory Phase 2 clinical study in 111 patients with oral mucositis due to CRT for head and neck cancer. Consistent with preclinical findings, SGX942 at a dose of 1.5 mg/kg demonstrated positive improvements in decreasing the duration of severe oral mucositis by 50% overall compared to the placebo group, from 18 days to 9 days (p=0.099). In patients at the highest risk of developing severe oral mucositis (i.e., those receiving concomitant cisplatin chemotherapy of 80-100 mg/m2 every third week), the reduction in the duration of severe oral mucositis was even more significant at 67% when treated with SGX942 1.5 mg/kg, from 30 days to 10 days (p=0.04). The p-values met the prospectively defined statistical threshold of p<0.1 in the study protocol. Additional observations included an improved tumor response to CRT at the one month follow-up visit, as well as decreases in mortality and infection rate. The study results are reviewed in "Dusquetide: A Novel Innate Defense Regulator Demonstrating a Significant and Consistent Reduction in the Duration of Oral Mucositis in Preclinical Data and a Randomized, Placebo-Controlled Phase 2 Clinical Study," published online in the Journal of Biotechnology and available at the following link: http://dx.doi.org/10.1016/j.jbiotec.2016.10.010.
Long-term (12 month) follow-up data further indicated the safety and tolerability of SGX942 treatment, with a sustained trend towards reduced mortality and increased tumor resolution in the 1.5 mg/kg SGX942 treatment group compared to the placebo group. Opioid pain medication use was also seen to decrease over the course of CRT in the 1.5 mg/kg SGX942 treatment group at the point of highest oral mucositis risk, while it increased in the placebo group. Detailed clinical results from the Phase 2 study, as well as a review of the pathogenesis of oral mucositis and the mechanism of action of SGX942, are discussed here. The long-term follow-up results from the Phase 2 study are reviewed in, "Dusquetide: Reduction in Oral Mucositis associated with Enduring Ancillary Benefits in Tumor Resolution and Decreased Mortality in Head and Neck Cancer Patients", published online in Biotechnology Reports and available at the following link: https://doi.org/10.1016/j.btre.2017.05.002.
Soligenix has received partial funding from NIDCR for its oral mucositis clinical studies. The Phase 2 study was supported with a Phase I SBIR grant (#R43DE024032) award, with the Phase 3 study being supported by a Phase II SBIR grant (#R44DE024032) award.
Drug products containing dusquetide have also received Fast Track Designations from the FDA for the treatment of oral mucositis as a result of radiation and/or chemotherapy treatment in head and neck cancer patients, and as an adjunctive therapy with other antibacterial drugs, for the treatment of melioidosis. Orphan Drug Designations for use of dusquetide in the treatment of MAS as well as for the treatment of acute radiation syndrome have also been granted. In addition, dusquetide has been granted Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of severe oral mucositis in head and neck cancer patients receiving CRT.
Soligenix has a strong intellectual property position in the IDR technology platform, including composition of matter for dusquetide and related analogs. Dusquetide was developed pursuant to discoveries made by Professors B. Brett Finlay, PhD and Robert Hancock, PhD of the University of British Columbia, Canada.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and 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).
Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
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. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "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 therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and 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 (TIMXX) 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. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy and the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. 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.
Soligenix Announces $1.5 Million NCI SBIR Grant Award Supporting the Pivotal Phase 3 Clinical Trial of SGX301 for the Treatment of Cutaneous T-Cell Lymphoma
Mon September 18, 2017 6:00 AM|PR Newswire|About: SNGX
PR Newswire
PRINCETON, N.J., Sept. 18, 2017 /PRNewswire/ -- Soligenix, Inc. (SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), has awarded Soligenix a Small Business Innovation Research (SBIR) grant of approximately $1.5 million over two years to support the conduct of its pivotal, Phase 3, randomized, double-blind, placebo-controlled study evaluating SGX301 (synthetic hypericin) as a treatment for cutaneous T-cell lymphoma (CTCL).
"We are appreciative of the financial support provided by NCI for our pivotal Phase 3 clinical study of SGX301 in the treatment of CTCL," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With the assistance of NCI, as well as important collaborators such as the National Organization for Rare Disorders and the Cutaneous Lymphoma Foundation, we look forward to completing this study in order to potentially address the unmet medical need that currently exists in this patient population."
Dr. Schaber continued, "We would like to thank NIH for its continued support and for its recognition of the merits of the important work we are doing in orphan diseases and areas of unmet medical need, as demonstrated by the approximate $6 million of additional non-dilutive funding it has awarded to Soligenix in 2017 across both our biotherapeutics and biodefense business segments. We will continue to be aggressive in our pursuit of government grants and contracts across our entire pipeline as a way to secure non-dilutive funding to support multiple development programs, while effectively managing our cash position."
SGX301 is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a potent photosensitizer that is applied to the cancerous skin lesions and activated using a brief treatment with safe fluorescent light. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure.
Based on the positive results demonstrated in the Phase 2 study of SGX301, the Phase 3 protocol is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial seeking to enroll 120 evaluable subjects. The trial consists of three treatment cycles, each of eight weeks duration. Treatments are administered twice weekly for the first six weeks and treatment response is determined at the end of Week 8. In the first treatment cycle, approximately 80 subjects will receive SGX301 and 40 will receive placebo treatment of their index lesions. In the second cycle, all subjects will receive SGX301 treatment of their index lesions, and in the third cycle all subjects will receive SGX301 treatment of all their lesions. Subjects will be followed for an additional six months after the completion of treatment. The primary efficacy endpoint will be assessed on the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a Partial or Complete Response (yes/no) of the treated lesions defined as a ≥ 50% reduction in the total Composite Assessment of Index Lesion Disease Severity (CAILS) score for 3 index lesions at the Cycle 1 evaluation visit (Week 8) compared to the total CAILS score at baseline.
Soligenix has been working with leading CTCL centers, as well as with the National Organization for Rare Disorders and the Cutaneous Lymphoma Foundation to conduct this pivotal Phase 3 clinical trial with SGX301, referred to as the FLASH study (Fluorescent Light Activated Synthetic Hypericin).
About Cutaneous T-Cell Lymphoma
CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin, causing various lesions to appear that may change shape as the disease progresses, typically beginning as a rash and eventually forming plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL.
CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 500,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL, that it affects over 20,000 individuals in the US, with approximately 2,800 new cases seen annually.
About SGX301
SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration, as well as orphan designation from the European Medicines Agency.
The Phase 3 CTCL clinical study is partially funded with a NCI Phase II SBIR grant (#R44CA210848) award to Soligenix, Inc.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and 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).
Our Vaccines/BioDefense business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, OrbeShield®, our GI acute radiation syndrome therapeutic candidate and SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
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. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "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 therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and 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 (TIMXX) 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. In addition, there can be no assurance as to the timing or success of the Phase 3 clinical trial of SGX942 (dusquetide) as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy and the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. 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.