PRINCETON, N.J., Feb. 13, 2020 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: 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 its RiVax(heat stable ricin toxin vaccine) development program for prevention of ricin intoxication has received "Fast Track" designation from the US Food and Drug Administration (FDA).
Fast track is a designation that the FDA reserves for a drug intendedto treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition.Fast track designation is intended to facilitate the development and expedite the review of new drugs and biologics.For instance, should events warrant, Soligenix will be eligible to submit a biologics license application (BLA) for RiVaxon a rolling basis, permitting the FDA to review sections of the BLA prior to receiving the complete submission.Additionally, BLAs for fast track development programs ordinarily will be eligible for priority review, which imparts an abbreviated review time of approximately six months.
"We are very pleased to have been granted fast track designation from the FDA to go along with the orphan drug designation previously received," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix."We believe that the FDA's action in granting fast track designation validates the unmet medical need that currently exists for a vaccine providing protection against lethal ricin toxin exposure and for the potential key role RiVaxcan serve as a part of the US Strategic National Stockpile."
The development of RiVax has been funded through a series of grants from both the National Institute of Allergy and Infectious Diseases (NIAID) and the FDA and ongoing development is sponsored by NIAID contract #HHSN272201400039C. Non-dilutive funding for the development of RiVax has exceeded $40 million to date.
About Ricin Toxin
Ricin toxin is a lethal plant-derived toxin and potential biological weapon because of its stability and high potency, and the fact that it is readily extracted from by-products of castor oil production.Ricin comes in many forms including powder, mist or pellet.Ricin can also be dissolved in water and other liquids.The US Centers for Disease Control and Prevention estimates that the lethal dose in humans is about the size of a grain of salt.Ricin toxin illness causes tissue necrosis and general organ failure leading to death within several days of exposure.Ricin is especially toxic when inhaled.Ricin works by entering cells of the body and preventing the cells from making the proteins they need.Without the proteins, cells die, which is eventually harmful to the entire body.
There are currently no effective treatments for ricin poisoning.The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used to vaccinate military personnel and civilian emergency responders at high risk of potential exposure in the event of a biological attack.
About RiVax
RiVax is Soligenix's proprietary heat stable recombinant subunit vaccine developed to protect against exposure to ricin toxin, the threat of which has been highlighted recently in the news with an envelope addressed to President Trump that was thought to contain this potent and potentially lethal toxin.With RiVax, Soligenix is a world leader in the area of ricin toxin vaccine research.
RiVax contains a genetically altered version of a Ricin Toxin A (RTA) chain containing two mutations that inactivate the toxicity of the ricin molecule. A Phase 1A clinical trial was conducted with a formulation of RiVax that did not contain an adjuvant.This trial revealed dose dependent seroconversion as well as lack of toxicity of the molecule when administered intramuscularly to human volunteers.The adjuvant-free formulation of RiVax induced toxin neutralizing antibodies that lasted up to 127 days after the third vaccination in several individuals.
To increase the longevity and magnitude of toxin neutralizing antibodies, RiVax was subsequently formulated with an adjuvant of aluminum salts (known colloquially as alum) for a Phase 1B clinical trial.Alum is an adjuvant that is used in many human vaccines, including most vaccines used in infants.The results of the Phase 1B study indicated that alum-adjuvanted RiVax was safe and well tolerated, and induced greater ricin neutralizing antibody levels in humans than adjuvant-free RiVax.In animal studies, the alum formulation of RiVax also induced higher titers and longer-lasting antibodies than the adjuvant-free vaccine.Vaccination with the thermostabilized alum-adjuvanted RiVax formulation in a large animal model provided 100% protection (p<0.0001) against acute exposure to aerosolized ricin, the most lethal route of exposure for ricin.The protected animals also had no signs of gross lung damage, a serious and enduring ramification with long-term consequences for survivors of ricin exposure.These results are described in a publication available here.
Heat stabilization of RiVax is achieved with the Company's proprietary ThermoVax technology, designed to eliminate the cold-chain production, distribution and storage logistics required for most vaccines.The technology utilizes precise lyophilization of protein immunogens with conventional aluminum adjuvants in combination with secondary adjuvants for rapid onset of protective immunity with the fewest number of vaccinations.By employing ThermoVax during the final formulation of RiVax, the vaccine has demonstrated enhanced stability and the ability to withstand temperatures at least as high as 40 degrees Celsius (104 degrees Fahrenheit) for up to one year. These results are described in a publication available here.
The development of RiVax has been funded through a series of grants from both the National Institute of Allergy and Infectious Diseases (NIAID) and the FDA and ongoing development is sponsored by NIAID contract #HHSN272201400039C. Non-dilutive funding for the development of RiVax has exceeded $40 million to date.RiVax is being developed under the FDA "Animal Rule" and potentially would be added to the Strategic National Stockpile and dispensed in the event of a terrorist threat.RiVax has received orphan drug designation in the US and in Europe.
As a new chemical entity, an FDA approved RiVax vaccine has the potential to qualify for a biodefense Priority Review Voucher (PRV), which allows the holder accelerated review of a drug application. Approved under the 21st Century Health Cures Act in late 2016, the biodefense PRV is awarded upon approval as a medical countermeasure when the active ingredient(s) have not been otherwise approved for use in any context.PRVs are transferable and can be sold, with sales in recent years in excess of $100 million.When redeemed, PRVs entitle the user to an accelerated review period of six months, saving a median of seven months' review time as calculated in 2009.However, the FDA must be advised 90 days in advance of the use of the PRV and the use of a PRV is associated with an additional user fee ($2.1 million in 2020).
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 Specialized 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 Public Health Solutions 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), the Defense Threat Reduction Agents (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at http://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.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 U.S. Government 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 U.S. 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 or the Phase 3 clinical trial of SGX301 (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma. Further, there can be no assurance that RiVax will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future.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.
View original content:http://www.prnewswire.com/news-releases/fda-grants-soligenix-fast-track-designation-for-rivax-in-the-prevention-of-ricin-poisoning-301004194.html
SOURCE Soligenix, Inc.
Continued here:
FDA Grants Soligenix "Fast Track" Designation for RiVax in the Prevention of Ricin Poisoning - BioSpace
- How dogs are paving the way for human longevity drugs - Longevity.Technology - April 12th, 2024 [April 12th, 2024]
- Innovative Approaches to Improving Human Longevity - Securities.io - April 12th, 2024 [April 12th, 2024]
- Top 5 Companies Offering Solutions to Increased Human Longevity - Securities.io - April 12th, 2024 [April 12th, 2024]
- Morning Medical Update: Gut bacteria and longevity; People with ... - Medical Economics - June 12th, 2023 [June 12th, 2023]
- Artificial Intelligence and the Aging Process: A Match Made for ... - Down to Game - June 12th, 2023 [June 12th, 2023]
- Saint Bernard Lifespan: How Long Do Saint Bernards Live? - AZ Animals - June 12th, 2023 [June 12th, 2023]
- 'Human Resources' Was Poised to Be Netflix's Longest-Running ... - PRIMETIMER - June 12th, 2023 [June 12th, 2023]
- Early Life Adversity Doesn't Affect Gorillas Like Other Species - The Good Men Project - June 12th, 2023 [June 12th, 2023]
- Wellness luminaries, experts to meet in KK - The Borneo Post - June 12th, 2023 [June 12th, 2023]
- I grew up with hazardous smoke from forest fires in Asia. Here's what ... - Morningstar - June 12th, 2023 [June 12th, 2023]
- Workplace Networks Are More Important than Promotions to Engage ... - GlobeNewswire - June 12th, 2023 [June 12th, 2023]
- Accenture staff working at Google training AI move to unionise - The Australian Financial Review - June 12th, 2023 [June 12th, 2023]
- Hair Wigs and Extension Market Size to Grow by USD 5.26 billion from 2021 to 2026, Growth Driven by Technologi - Black Enterprise - April 10th, 2023 [April 10th, 2023]
- Want to age like a fine wine? Here are some tips for longevity and feeling younger - The Indian Express - February 18th, 2023 [February 18th, 2023]
- Human body | Organs, Systems, Structure, Diagram, & Facts - January 27th, 2023 [January 27th, 2023]
- Human | Avatar Wiki | Fandom - January 27th, 2023 [January 27th, 2023]
- Calorie Restriction and Fasting Diets: What Do We Know? - January 4th, 2023 [January 4th, 2023]
- Emma Thompson On Longevity Of Holiday Fave Love Actually But It Is SEX Actually That Is Earning Her Awards Buzz In Leo Grande - Deadline - December 26th, 2022 [December 26th, 2022]
- Heads or tails: What statistical models tell us about the probability of living beyond 110 - The Conversation - December 12th, 2022 [December 12th, 2022]
- LinkedIn founder and VC Reid Hoffman says human amplification via A.I. will revolutionize large enterprises in the next five years - Fortune - December 12th, 2022 [December 12th, 2022]
- Human hibernation is possible and could boost longevity | New Scientist - December 2nd, 2022 [December 2nd, 2022]
- Home - Human Longevity Institute - October 23rd, 2022 [October 23rd, 2022]
- Exercise: 7 benefits of regular physical activity - Mayo Clinic - October 23rd, 2022 [October 23rd, 2022]
- Life expectancy - Wikipedia - October 13th, 2022 [October 13th, 2022]
- Life Expectancy - Our World in Data - October 13th, 2022 [October 13th, 2022]
- The Longevity Investors Conference Gstaad brought together longevity experts and deep-pocketed investors - Cointelegraph - October 13th, 2022 [October 13th, 2022]
- The Search for a Pill That Can Help Dogsand HumansLive Longer - WIRED - October 13th, 2022 [October 13th, 2022]
- Aging of the Heart Correlates With a Poor Gut Microbiome - Lifespan.io News - October 13th, 2022 [October 13th, 2022]
- Aditxt, Inc. (Nasdaq: ADTX) Announces Development and Publication of a Mathematical Model for Predicting Longevity and Variations of Immune Response... - October 13th, 2022 [October 13th, 2022]
- FOXO Technologies Announces First Distribution Partner and Begins Product Rollout in California; Expands Executive Team With Insurance Industry Talent... - October 13th, 2022 [October 13th, 2022]
- A conversation with Holocaust scholar Dr. Irving Berkowitz - South Florida Sun Sentinel - October 13th, 2022 [October 13th, 2022]
- Nine postdoctoral fellowships in aging research awarded by the Glenn Foundation for Medical Research and AFAR - EurekAlert - October 13th, 2022 [October 13th, 2022]
- The 5 Wellness Habits That Slow Down Aging, Science Reveals Eat This Not That - Eat This, Not That - October 13th, 2022 [October 13th, 2022]
- Winning Federal Contracts on the Top 20 Contract Vehicles - Bloomberg Government - October 13th, 2022 [October 13th, 2022]
- Lawrence Austin promoted to rank of colonel - Winona Times - October 13th, 2022 [October 13th, 2022]
- The longevity dividend: Work in an era of 100-year lives - October 2nd, 2022 [October 2nd, 2022]
- Retirement Savings Calculator - Northwestern Mutual - October 2nd, 2022 [October 2nd, 2022]
- Clues to Human Longevity Unearthed in Largescale Mouse Genetic Study - Genetic Engineering & Biotechnology News - October 2nd, 2022 [October 2nd, 2022]
- Can we find ways to live beyond 100? Millionaires are betting on it. - MIT Technology Review - October 2nd, 2022 [October 2nd, 2022]
- Restrict Calories to Boost Immune Function - The Epoch Times - October 2nd, 2022 [October 2nd, 2022]
- The Black Progress Index: Examining the social factors that influence Black well-being - Brookings Institution - October 2nd, 2022 [October 2nd, 2022]
- Kevin Williamson on Scream 6 and Franchise Longevity - Bleeding Cool News - October 2nd, 2022 [October 2nd, 2022]
- 507-Year-Old Clam May Be the World's Oldest Living Being - History of Yesterday - October 2nd, 2022 [October 2nd, 2022]
- I should look forward to early retirement, but I think I'm dreading it - CBC.ca - October 2nd, 2022 [October 2nd, 2022]
- International Coffee Day 2022: How The Beloved Brew Helps Fight Cancer, Kidney Disease And Depression - ABP Live - October 2nd, 2022 [October 2nd, 2022]
- Corey Feldman And Jamison Newlander Talk The Lost Boys And The Birth Of The Two Coreys - Forbes - October 2nd, 2022 [October 2nd, 2022]
- Proven Levels of Human Longevity | NextBigFuture.com - September 11th, 2022 [September 11th, 2022]
- Prolonging healthspan by delaying ageing -- NUHS opens Singapore's first Centre for Healthy Longevity to increase healthy lifespan of Singapore... - September 11th, 2022 [September 11th, 2022]
- What is the Secret to Longevity in Real Estate? - CandysDirt.com - Candy's Dirt - September 11th, 2022 [September 11th, 2022]
- Jeff Stukey & Jay Olshansky, Ph.D with Wealthspan Advisors, Interviewed on the Influential Entrepreneurs Podcast Discussing How Aging Science... - September 11th, 2022 [September 11th, 2022]
- The Queen of the World - The Atlantic - September 11th, 2022 [September 11th, 2022]
- THR Icon: At 100, Norman Lear Looks Back (And Ahead) at Whats Changed Since the Maude Abortion Episode - Hollywood Reporter - September 11th, 2022 [September 11th, 2022]
- TIFF 2022: The Colour of Ink Review - ThatShelf.com - September 11th, 2022 [September 11th, 2022]
- Should Age Be on the Ballot? - Next Avenue - September 11th, 2022 [September 11th, 2022]
- Was The Spring Water At Balmoral Castle The Secret To Elizabeth II's Longevity? - Nation World News - September 11th, 2022 [September 11th, 2022]
- A complete guide to the health benefits of nuts europeantimes.news - The European Times - September 11th, 2022 [September 11th, 2022]
- Debut Launches its Bio2Consumer Platform to Become the Leader in Vertically Integrated Synthetic Biology - PR Web - September 11th, 2022 [September 11th, 2022]
- Rapamycin Drug Used in Cancer Therapy Found to Increase Human Lifespan [Study] - Nature World News - August 30th, 2022 [August 30th, 2022]
- Eating Healthy: Why Eating Grapes Would Increase Lifespan | The Guardian Nigeria News - Nigeria and World News Guardian Life The Guardian Nigeria... - August 30th, 2022 [August 30th, 2022]
- Beauty Bets on Longevity WWD - WWD - August 30th, 2022 [August 30th, 2022]
- Analysis of the impact of success on three dimensions of sustainability in 173 countries | Scientific Reports - Nature.com - August 30th, 2022 [August 30th, 2022]
- You might have glowing skin in no time by making few easy changes to your skincare routine - TDPel Media - August 30th, 2022 [August 30th, 2022]
- Nucleai Appoints New Head of Pathology to Support Expansion in Biopharmaceutical and Clinical Markets - Business Wire - August 8th, 2022 [August 8th, 2022]
- Daily AI Roundup: Biggest Machine Learning, Robotic And Automation Updates - AiThority - August 8th, 2022 [August 8th, 2022]
- Prolonged and intense heatwave affecting parts of western and northern Europe breaks temperature records; globally, July 2022 was one of three warmest... - August 8th, 2022 [August 8th, 2022]
- YLEM: Augmenting sustainable futures through material exploration and testing - STIRworld - August 8th, 2022 [August 8th, 2022]
- Do you want to live forever? Big Tech and the quest for eternal youth - The New Statesman - August 6th, 2022 [August 6th, 2022]
- This startup wants to copy you into an embryo for organ harvesting - MIT Technology Review - August 6th, 2022 [August 6th, 2022]
- Renewal Bio Acquires Breakthrough Stem Cell Technology With Applications in Infertility and Longevity - Benzinga - August 6th, 2022 [August 6th, 2022]
- Get married or get a degree to live longer says study, debunking theories of womens longevity over men - Times Now - August 6th, 2022 [August 6th, 2022]
- Nucleai Appoints New Head of Pathology to Support Expansion in Biopharmaceutical and Clinical Markets - StreetInsider.com - August 6th, 2022 [August 6th, 2022]
- Some species are immortal but dying of old age is humanity's secret weapon - The Telegraph - August 6th, 2022 [August 6th, 2022]
- Opinion: Changing When and How Much We Eat May Extend Health Span - The Scientist - August 6th, 2022 [August 6th, 2022]
- Vieroots uses genome testing to win over a growing tribe of wellness enthusiasts - YourStory - August 6th, 2022 [August 6th, 2022]
- Herbs radiate and give you youthful skin - The Hans India - August 6th, 2022 [August 6th, 2022]
- How Pop Culture, Politics, Science, and Business Got So Old - The Atlantic - August 6th, 2022 [August 6th, 2022]
- John Hood: How to read this column | Columnists | journalnow.com - Winston-Salem Journal - August 6th, 2022 [August 6th, 2022]
- How Long Is The Human Lifespan? Here's What Studies Have Found | mindbodygreen - mindbodygreen - July 31st, 2022 [July 31st, 2022]
- Employees are livingand workinglonger. CEOs are introducing initiatives like phased retirements to harness the longevity economy - Fortune - July 31st, 2022 [July 31st, 2022]
- Why Do We Get Old, and Can Aging Be Reversed? - Quanta Magazine - July 31st, 2022 [July 31st, 2022]