Digital Asset DirectEmpower Clinics Inc.
Contact Details Proactive Investors Canada Proactive Studio +1 604-688-8158 na-editorial@proactiveinvestors.com Company Website https://www.proactiveinvestors.ca/
December 08, 2022 08:44 AM Pacific Standard Time
Video
News ReleaseSunshine Biopharma Inc.
Read the latest report on Sunshine Biopharma here. Protests have mounted in intensity across China in the past weeks, as more and more citizens become frustrated with the country’s radical “Zero-Covid” policies. This was part of the cause for the markets having a rocky opening last week, with Tesla, Inc. (NASDAQ: TSLA) and Apple, Inc. (NASDAQ: AAPL) stock falling and a widespread drop in the oil sector in response to the continuing instability. This uncertainty is a reminder that, even as some describe living with the virus as a ‘new normal,’ complacency toward Covid carries risks. Clearly, there is a need for more effective solutions. Sunshine Biopharma, Inc. (NASDAQ: SBFM) is a Canada-based pharmaceutical company combating COVID-19 through the development of SBFM-PL4, an antiviral treatment. It believes this drug, which it anticipates could be taken in tablet form from home, could be the kill shot for COVID and could help finally put an end to the pandemic. Partnering With The University of Arizona University For Covid Research A fully integrated pharmaceutical company, Sunshine Biopharma specializes in the research and development (R&D) of oncological and antiviral treatments and has multiple ongoing development projects, including SBFM-PL4. The strong team at Sunshine recently started a collaboration with the University of Arizona. Led by Dr. Gregory Thatcher, the collaboration will continue research into SBFM-PL4, and involve testing PLpro inhibitors to see how the drug reacts with the immune system. While companies like Pfizer (NYSE: PFE), Eli Lilly and Co. (NYSE: LLY), and Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) have developed treatments for COVID, concerns around these drugs range from their limited efficacy to questions around their safety and drug resistance. Meanwhile, Sunshine’s drug targets nsp3 protease, the enzyme which suppresses the patient’s immune system and allows the Covid virions to effect maximal damage. As an nsp3 protease inhibitor, SBFM-PL4 doesn’t merely weaken the virus, like other treatments, but also supports overall health by allowing the patient’s immune system to fight back. The company is confident that, in a Covid-19 vaccine market worth $13.6 billion, its drug candidate could provide a welcome solution. “It is urgent that effective treatments and more specific vaccines be developed at an accelerated pace,” said Dr. Steve Slilaty, CEO of Sunshine Biopharma. “We are delighted to be working with Dr. Gregory Thatcher, who is aiming to find a wide array of inhibitors for PLpro (also called nsp3), as this virus-encoded protease is responsible for the suppression of the human immune system.” Along with this important collaboration, Sunshine Biopharma can reflect proudly on a year that saw the company report growth in its financial position and a recent acquisition that may help the company enter the generic prescription drug market and become profitable. It is also developing a drug – Adva-27a – which it believes will be successful in treating various forms of multidrug-resistant cancer. In addition, the company is developing a vaccine-like mRNA treatment for cancer. Want to learn more about Sunshine Biopharma? Visit its website. In addition to working with the University of Arizona on the development of a treatment for COVID-19, Sunshine Biopharma is engaged in the development Adva-27a, a unique anticancer compound. Tests conducted to date have demonstrated the effectiveness of Adva-27a at destroying Multidrug Resistant Cancer Cells, including Pancreatic Cancer cells, Small-Cell Lung Cancer cells, Breast Cancer cells, and Uterine Sarcoma cells. Clinical trials for Pancreatic Cancer indication are planned to be conducted at McGill University’s Jewish General Hospital in Montreal, Canada. Sunshine Biopharma is also engaged in the development of a novel anticancer mRNA called K1.1. The data collected to date have shown that K1.1 mRNA is capable of destroying cancer cells in vitro including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). Studies using non-transformed (normal) human cells (HMEC) have shown that K1.1 mRNA had little or no cytotoxic effects. K1.1 mRNA is readily adaptable for delivery into patients using the proven mRNA vaccine technology. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Christine Petraglia - TraDigital IR +1 917-633-8980 investors@sunshinebiopharma.com Company Website https://sunshinebiopharma.com/
December 08, 2022 09:25 AM Eastern Standard Time
News ReleaseAmeriLife
Agent Support Group (ASG), one of the oldest and most established life insurance brokerages in the U.S. and an affiliate of AmeriLife Group, LLC (“AmeriLife”), today announced the elevation of Jay Scheiner to CEO of the firm and principal with AmeriLife. Scheiner succeeds Sam Kaufman, who recently announced his retirement after leading Agent Support Group through 50 years of growth and innovation. Scheiner will take over day-to day operations while focusing on its core business of providing advanced case design and underwriting support for life insurance, long-term care and annuities. “Our core mission at ASG is to provide concierge-level service to life insurance agents, financial advisors, and professionals in other insurance disciplines, helping them develop and expand the life insurance area of their practice,” said Scheiner. “I look forward to continuing ASG’s strong legacy and accelerating our growth as an integral part of the AmeriLife team.” In a related decision, ASG Partner Gary Bleetstein also announced his retirement after 16 years with the firm and more than 45 years of success in key roles in the insurance industry. With Bleetstein’s retirement, ASG’s Mark Milbrod will assume the role of vice president and continue to assist ASG in providing unrivaled service to its client partners. Scheiner takes the reigns of ASG at a pivotal moment for both the business and its brand, as it re-introduces itself to the insurance market under the name ASG, An AmeriLife Company. The firm’s new name and logo reflect its legacy as one of the longest-serving life brokerages in the New York metropolitan area and its deep, long-held connection with AmeriLife, while also repositioning it as a forward-looking firm that supports the modern financial advisor. “Jay and Mark are the right leaders for the moment, and we look forward to working closely with them as they usher ASG into a new and exciting era,” added Mike Vietri, AmeriLife’s Chief Distribution Officer. “We’re also incredibly grateful for the leadership and contributions of both Sam and Gary over the many years, and wish them well in retirement.” ### About ASG, An AmeriLife Company Founded in 1973, ASG (formerly known as Agent Support Group) provides insurance services for professional advisors, including advanced case design for estate and business planning life insurance, impaired risk underwriting, and point of sale assistance for life, annuity, disability and long-term care insurance. ASG, which has its principal offices in New York City and Manhasset, N.Y., is a member of LIBRA Insurance Partners, assuring direct access to top-rated carriers and underwriting. For more information, visit ASGLife.com. About AmeriLife AmeriLife’s strength is its mission: to provide insurance and retirement solutions to help people live longer, healthier lives. In doing so, AmeriLife has become recognized as the leader in developing, marketing, and distributing life and health insurance, annuities and retirement planning solutions to enhance the lives of pre-retirees and retirees across the United States. For more than 50 years, AmeriLife has partnered with top insurance carriers to provide value and quality to customers served through a distribution network of over 300,000 insurance agents and advisors and more than 100 marketing organizations and insurance agency locations nationwide. For more information, visit AmeriLife.com, and follow AmeriLife on Facebook and LinkedIn. Contact Details Media Jeff Maldonado +1 321-297-1112 jmaldonado@amerilife.com Partnership Inquiries Patrick Nichols +1 727-726-0726 pnichols@amerilife.com Company Website https://amerilife.com/
December 08, 2022 09:00 AM Eastern Standard Time
Digital Asset DirectMGC Pharmaceuticals Ltd
Contact Details Proactive Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
December 08, 2022 08:46 AM Eastern Standard Time
Video
News ReleaseAiViva BioPharma
Interested in investing in AiViva’s campaign? Click here to get started! Scarring can have negative physical, aesthetic, and psychological effects if left untreated. A growing awareness of treatment options and technological advancements has given its treatment industry adoption a boost. Scars result from injuries, surgeries, illness, burns and acne. Scars form on your skin or inside your body when one heals an injury or trauma. Our body’s wound healing process can cause the overproduction of collagen, a protein found in the dermis or second layer of the skin, resulting in raised lumpy scarring or keloids. Keloids tend to grow larger over time and in some cases, reappear after treatment. A scar never completely goes away. When it comes to scarring, where it occurs matters. A wound in an area that moves, like your elbow and knee, is more likely to scar. A scar on the face would be harder to heal because one’s face is constantly exposed to the environment. The Growing Market For Scar and Keloid Treatments The keloid and scar treatment market is burgeoning. One reason for this could be an increasing number of accidents, surgeries, and other injuries around the world each year. The combined hypertrophic and keloid scar treatment global market was valued at $6.34 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 8.47% from 2022 to 2030. Companies like Sanoma Pharmaceuticals (NASDAQ: SNOA) are partnering with e-commerce sites like Amazon.com Inc. (NASDAQ: AMZN) to provide hypertrophic and keloid scar treatment products in the U.S. Partnerships like this are also expected to drive the retail pharmacy segment. There are reportedly no approved drugs on the market for the prevention of scars following surgery. The appearance of scar may be improved by laser therapy, steroid injections, or silicon sheets. Dermatologists and plastic surgeons may surgically remove a scar to restore function of a body part that may have been restricted by the scar. Keloid scars are difficult to get rid of and tend to return after treatment in a majority of cases. Current treatments for keloids include steroidal injections at the scar site, cryosurgery (freezing), keloidectomy (surgical removal), pressure dressings, silicone sheeting and gels and radiation. While each of these treatment options by themselves, or when combined with others, could help by treating and improving physical appearance and skin sensitivity issues such as itch and pain, a scar never goes away. How AiViva’s AIV001 Treatment Could Address Scar Formation AIV001 is a compound that could address the negative impacts of scarring. AIV001 has been found to be effective in modulating inflammation and scarring of the skin as well as reducing neovascularization (cell proliferation) associated with some cancers, according to AiViva. The company says it has seen positive signals from its phase I clinical trial of AIV001 for incision-based dermal scarring and wound healing. Trial results showed that AIV001 was safe and well tolerated in the local intradermal treatment of incisional wounds and reduced fibrosis through only a single dose with no systemic side effects observed in humans. These results suggest that the intradermal AIV001 treatment could potentially have significant clinical utility by modulating the aberrant scarring associated with fibrosis during the wound-healing process. “Scarring has been a significant issue that can cause debilitating aesthetic, functional and psychological effects. There are no (Food and Drug Administration) FDA-approved therapeutics for the treatment of post-operative scars, therefore, AIV001 has the potential to be a transformative treatment in this space,” AiViva CEO Diane Tang-Liu said. About AiViva Biopharma: AiViva Biopharma, is a clinical stage biotech company founded in 2015 by four pharmaceutical industry veterans with more than 300 years of combined industry experience. AiViva's founders have demonstrated a successful track record across the full spectrum of drug development and commercialization, in addition to raising capital, and IPOs on the NYSE and NASDAQ.AiViva was formed with the mission of developing novel, innovative pharmaceutical products through an efficient, risk-mitigated development strategy to address major unmet medical needs. The company has raised over $30 million in capital so far, including over $10 million raised in 2022. AiViva was rated as a top 20 clinical-stage biopharma company by Life Sciences Review in 2022. Interested in investing in AiViva? Click here. If you would like to learn more about AiViva, check out its website. AiViva is a clinical stage biotech company which has created proprietary technology and new treatments to address significant, unmet medical needs in ophthalmology, dermatology, urology, and oncology. The company is led by a team of seasoned industry experts who have an outstanding track record in successful drug development, commercialization, and multiple IPOs on the NYSE and NASDAQ. The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. Benzinga may receive monetary compensation from the issuer, or its agency, for publicizing the offering of the issuer’s securities. This content is for informational purposes only and is not intended to be investing advice. This is a paid ad. Please see 17(b) disclosure linked in the campaign page for more information. Contact Details Michael office@aiviva.com Company Website https://aiviva.com/
December 08, 2022 08:00 AM Eastern Standard Time
News ReleaseUnicycive Therapeautics, Inc.
In the U.S., reimbursement of dialysis expenses by the Centers for Medicare & Medicaid Services (CMS) is done using a prospective payment system (PPS) which enables the payout of a predetermined amount to providers of dialysis services. In October, the CMS published its “Final Rule” updating payment rates and policies for the PPS for end-stage renal disease (ESRD), for the calendar year 2023. The ESRD PPS, often referred to as “the bundle”, is the government-funded program that pays for renal dialysis services and certain prescription drugs for patients with late-stage chronic kidney disease (CKD). A category of drugs called phosphate binders that dialysis patients need to be able to control a severe complication of their disease known as hyperphosphatemia is currently not covered under the ESRD PPS. Therefore, dialysis patients currently resort to sourcing their phosphate binders through prescription drug plans run by for-profit insurance companies, a process which is fraught with challenges due to these branded prescriptions being more expensive and difficult to access. In the 2023 Final Rule, the CMS commented on its intention to include phosphate binders in the bundle, stating that the addition of phosphate binders would “mitigate the risk of potential access issues for minority populations, which include African-American/Black, Asian, Hispanic, and Other non-white populations, promote health equity for patients that lack Medicare Part D coverage or have coverage less generous than the Part D standard benefit, and contribute to better clinical outcomes by leveling the playing field for all patients with ESRD”. This change is slated to be implemented in 2025 through the TDAPA (transitional drug add-on payment adjustment) –- a direct government payment program that takes the reimbursement process out of the hands of private insurance companies. During a minimum 2-year TDAPA period starting in 2025, CMS will evaluate the additional cost of adding phosphate binders into the PPS “bundle” and then make the change permanent. CMS’s goal in this planned change to phosphate binder reimbursement is to “result in better drug therapy management for the ESRD beneficiary, and to improve their access to these medications”. This development could be great news for Unicycive Therapeutics Inc. (NASDAQ: UNCY). The company is developing what they believe to be a best-in-class phosphate binder they hope to get approved by the FDA in 2024. The company is developing an investigational new drug called Renazorb TM (lanthanum dioxycarbonate that binds and eliminates phosphate in the gastrointestinal tract. Renazorb utilizes a proprietary nanoparticle technology being developed by Unicycive for the treatment of hyperphosphatemia in CKD patients on dialysis. Unicycive says that it has completed a clinical trial studying Renazorb in 32 healthy volunteers with encouraging results – as per the study Renazorb was minimally absorbed into the systemic circulation and was safe and well-tolerated at doses up to 6000 mg/day. Renazorb was found to significantly reduce urine phosphate excretion and significantly increase fecal phosphate excretion at doses at and above 3000 mg/day. The company says that Renazorb offers potential advantages over the most commonly used phosphate binder – Renvela – because it dramatically reduces the number and size of pills that patients are required to take. Many people suffering from CKD are weighed down by a high pill burden due to their various other comorbidities that require taking multiple pills. This leads to patients neglecting to take their medication because they are overwhelmed by the number and size of the pills they must take. Unicycle says that the efficiency and smaller size of Renazorb pills could reduce the pill burden for these patients by 3 to 4 fold. Renazorb also has an added convenience for patients since it is swallowed with water instead of having to be chewed. Renazorb is protected by patents in the U.S. and other countries outside the U.S. including Canada, Europe, Japan, China, and Australia, with validity until 2031. “Gaining early patient access and reimbursement for newly launched branded drugs can be a challenge” stated Doug Jermasek, Executive Vice President at Unicycive. “For-profit insurance plans often restrict access to new drugs or impose very high patient copays. Beginning in 2025, and coinciding with the expected launch of our promising new medicine, these barriers will be removed for patients and their healthcare providers. We are excited by the potential to launch RENAZORB into this new environment of expanded patient access.” Unicycive is also developing a drug for the treatment of acute kidney injury – namely UNI 494 – for which the company is filing to begin Phase 1 human trials. Other companies developing drugs for the treatment of CKD include Ardelyx Inc. (NASDAQ: ARDX), Akebia Therapeutics Inc. (NASDAQ: AKBA), and Cara Therapeutics. ( NASDAQ: CARA). To learn more about Unicycive visit its website. Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Anne Marie Fields - Stern Investor Relations +1 212-362-1200 annemarie.fields@sternir.com Company Website https://unicycive.com/
December 08, 2022 08:00 AM Eastern Standard Time
News Release500NewsWire
Charlotte, NC ( 500NewsWire ) -- Firebirds Wood Fired Grill introduces new holiday lunch and dinner menus just in time to make any celebration a memorable one this holiday season. From hand-cut wood-fire grilled NY Strip, and certified Duroc pork chop with cognac cream sauce, to Bananas Foster Bread Pudding for dessert, Firebirds’ limited time scratch-made menus are available now through January 3. Firebirds Wood Fired Grill is known for its signature hand-cut steaks and fresh seafood hand-fileted in-house and seared over locally sourced hickory, oak, or pecan wood on Firebirds’ exposed wood-fired grill. Firebirds’ seasonal Lunch Menu includes suggested wine pairings, and features: NY Strip (10oz.) BLT butter / choice of side Suggested wine pairing: Decoy Cabernet Sauvignon Parmesan Crusted Mahi Coal-roasted tomato-basil sauce / “loaded “ember-grilled corn / fresh asparagus Suggested wine pairing: Decoy Chardonnay Lump Crab Cakes Bold remoulade / wonton slaw / seasoned steak fries Suggested wine pairing: Firebirds Private Label Chardonnay Guests can enhance their entrées by adding: Lump Crab Cake Lobster Mac & Cheese Dessert Bananas Foster Bread Pudding Vanilla bean ice cream / spiced pecans / crispy cinnamon-sugar tortilla Firebirds’ seasonal Dinner Menu includes suggested wine pairings, and features: NY Strip (14oz.) BLT butter / choice of side Suggested wine pairing: Decoy Cabernet Sauvignon Tomahawk Prime Pork Chop Wood-grilled, certified Duroc pork chop / cognac cream sauce / red wine-poached apples / green chile mac & cheese Suggested wine pairing: Acrobat Pinot Noir Parmesan Crusted Mahi Coal-roasted tomato-basil sauce / “loaded “ember-grilled corn / fresh asparagus Suggested wine pairing: Decoy Chardonnay Lump Crab Cakes Bold remoulade / wonton slaw / seasoned steak fries Suggested wine pairing: Firebirds Private Label Chardonnay Guests can enhance their entrees by adding: Lump Crab Cake Lobster Mac & Cheese Dessert Bananas Foster Bread Pudding Vanilla bean ice cream / spiced pecans / crispy cinnamon-sugar tortilla Many of the restaurant’s dishes are created using fresh seasonal ingredients. Gluten-sensitive menu items, such as Grilled Tenderloin Salad, Wood Grilled Salmon, and Parmesan Mashed Potatoes, are also available. Firebirds offers catering, online ordering for ToGo and delivery options. In addition, Firebirds is offering a holiday gift card promotion. For every $100 in gift cards purchased in-store or online, guests will receive $20 in “bonus cards.” This special offer is available now through December 31st and “bonus cards” are valid for redemption from January 1 through February 9, 2023. For more information visit firebirdsrestaurants.com/gift-cards/. Firebirds Wood Fired Grill’s FIREBAR® offers an impressive array of seasonal cocktails, craft beer, bourbon, after-dinner drinks, Firebirds’ private label wine, hand crafted mocktails and more. Popular specialties include Wine Down Mondays, and happy hour in the FIREBAR® and on the Patio every Monday through Friday from 4PM – 7PM. Happy Hour times vary. Visit FirebirdsRestaurants.com to make a reservation, order ToGo online, or register to become a member of Firebirds’ Inner Circle and be the first to hear about upcoming events, promotions, new menu items and exclusive offers. Members receive a gift for joining and a gift for their birthday. About Firebirds Wood Fired Grill Firebirds Wood Fired Grill, a polished casual American restaurant, is an energetic twist on the traditional grill featuring a boldly flavored menu in a stylish, fire-centric atmosphere. Signature menu items include hand-cut steaks and fresh seafood hand-fileted in-house and seared over locally sourced hickory, oak, or pecan wood on Firebirds’ exposed wood-fired grill. Complementing its inviting dining room, a patio with seasonal comforts and the award-winning FIREBAR® are additional gathering spaces inside the restaurant. Firebirds has been named one of ten ‘Breakout Brands’ by Nation’s Restaurant News, and the 2022 Diners’ Choice Winner awarded by OpenTable. Firebirds supports sustainability efforts and partners with Alex’s Lemonade Stand Foundation, having surpassed $3 million raised for childhood cancer research through the sale of fresh-squeezed lemonade. To become a member of Firebirds Inner Circle, order ToGo online or to make a reservation visit firebirdsrestaurants.com. Contact Details Firebirds Wood Fired Grill Lesley Gamwell +1 404-309-6915 lgamwell@rountreegroup.com Company Website https://firebirdsrestaurants.com/
December 07, 2022 08:59 AM Eastern Standard Time
News ReleaseEnlivex Therapeutics, Ltd.
Enlivex Therapeutics Ltd. (NASDAQ: ENLV) announced that Israel, Spain and Greece have cleared amendments to the company’s Phase II trial protocol that will allow the study to enroll more patients. The cleared amendments also allow Enlivex to use a newly developed frozen formulation of Allocetra TM — the macrophage reprogramming immunotherapy it’s evaluating as a potential sepsis treatment in the clinical trial. The Current Standard Of Care For Sepsis Needs Improvement Each year, about 1.7 million U.S. adults develop sepsis in response to an infection. Of those, about 350,000 will die from septic shock, according to the Centers for Disease Control (CDC). Despite the risks of sepsis, there is currently no specific treatment for the life-threatening condition. That’s because it’s not a pathogen in its own right but an extreme response to an infection the patient already has. That underlying infection can be bacterial, fungal or viral so treating sepsis often starts with identifying the underlying infection and administering the appropriate antibiotic, antimicrobial or antiviral treatment. This initial treatment, along with intravenous fluids and vasopressors to maintain organ function and blood pressure, forms the current standard of care, but they’re really just a way of keeping the patient alive while their immune system, hopefully, fights the infection causing the sepsis response. Even with this standard of care, timing is everything. In a study of New York State Department of Health data, researchers found that for each hour antibiotic treatment was delayed in patients with sepsis, the risk of mortality increased by 4%. In other words, patients need to receive treatment as soon as possible to increase the odds of survival. This large unmet need has motivated many pharmaceutical companies to explore new treatment options, but so far, few have shown significant promise. For example, monoclonal antibodies (mAbs), like Merck & Co. Inc. ’s (NYSE: MRK) bezlotoxumab or Aridis Pharmaceuticals Inc. ’s (NASDAQ: ARDS) tosatoxumab, have made some headway, but these are engineered to target specific infections. So doctors would need to identify the specific mAb to use and hope that one exists for that particular infection, which is not a guarantee since mAbs are still relatively new. Enlivex’s Allocetra Is An Immunotherapy That Could Rebalance The Immune Response At its core, sepsis is an extreme immune response to an infection in the body. That’s why Enlivex has chosen to explore immunotherapy options for treating the condition. Allocetra TM, it’s leading drug candidate, works by reprogramming macrophages from healthy donor cells to help the patient’s own macrophages return to their homeostatic state of stability. Macrophages are a type of immune cell that circulates throughout the body, monitoring for signs of infection. When a pathogen is spotted, they immediately “eat” it and send out an alarm signal to the rest of the immune system. Certain conditions, like sepsis, can disrupt macrophages, triggering an excessive inflammatory response that can end up causing the organ damage and organ failure that make sepsis so life-threatening. Allocetra’s formula uses donor macrophages that have been programmed to send out an “eat me” signal to the host’s macrophages. Once engulfed, the donor cells then reprogram those host macrophages to return to their homeostatic state. In the preclinical and clinical trials Enlivex has completed so far, that return to homeostasis has resulted in reduced mortality and improved sequential organ failure assessment (SOFA) scores, suggesting that the immunotherapy could help moderate the immune response and protect organs from damage and failure. While antimicrobials will still be necessary for fighting the underlying infection, Allocetra’s ability to influence the host’s overactive immune response could become an essential tool for preventing long-term damage and reducing mortality rates. The Phase II Clinical Trial Will Include An Expanded Patient Population And A More Shelf-Stable Version Of Allocetra Initially, the Phase II trial was limited to patients with pneumonia-associated sepsis. With the recent amendments cleared by Israel, Spain and Greece, Enlivex is now able to expand the trial to include patients with sepsis related to biliary, urinary tract and peritoneal infections. The amendments also clear the way for the clinical-stage immunotherapy company to treat patients in the trial with its newer frozen formulation of Allocetra. In development for the last two years, frozen Allocetra is expected to have a shelf life spanning years rather than the 96-hour shelf life of the liquid version. A longer shelf life means Enlivex can manufacture the novel immunotherapy at scale and hospitals can keep it in stock so that it’s readily available for rapid deployment for the treatment of sepsis patients. Enlivex plans to submit these same protocol amendments in other jurisdictions in hopes of further expanding its Phase II research. But with the regulatory clearance achieved so far, the company is optimistic that it can shorten the timeline to potential approval of frozen Allocetra as a sepsis treatment, which could move up the date of a possible commercial launch. As part of a new generation of companies representing the future of cell therapy – off-the-shelf, highly scalable and low COGS “beyond CAR-T” cell therapies – Enlivex is focused on a highly differentiated novel immunotherapeutic mechanism – macrophage homeostasis. Macrophage homeostasis is severely disrupted by certain diseases states, and such imbalance is critical to the progression of the diseases. Allocetra has the potential to introduce highly-effective, low-cost allogeneic cell therapies for life-threatening clinical indications that are defined as "unmet medical needs", including sepsis – one of the leading causes of mortality, and oncology, through restoration of macrophage homeostasis. Enlivex is led by a seasoned management team who founded PROLOR Biotech and led it to a successful $560 financial exit and a partnership with Pfizer. PROLOR’s lead product, now named NGenla® by Pfizer, recently received marketing approval in Australia, Canada, Japan and the EU. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “would”, “could,” “intends,” “estimates,” “suggests,” “has the potential to” and other words of similar meaning, including statements regarding expected cash balances, market opportunities for the results of current clinical studies and preclinical experiments, the effectiveness of, and market opportunities for, ALLOCETRA TM programs. All such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect Enlivex’s business and prospects, including the risks that Enlivex may not succeed in generating any revenues or developing any commercial products; that the products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the ALLOCETRA TM product line could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in Enlivex’s filings with the Securities and Exchange Commission, including in the Company’s most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. Contact Details Shachar Shlosberger shachar@enlivexpharm.com Company Website https://enlivex.com
December 07, 2022 08:40 AM Eastern Standard Time
Digital Asset DirectFrontier IP Group PLC
Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
December 07, 2022 08:24 AM Eastern Standard Time
Video
Contact Us
Pricing
About us
Features
News Hub
Terms of Use
Privacy Policy