PALM BEACH, Fla., Dec. 15, 2020
Financialnewsmedia.com News Commentary
PALM BEACH, Fla., Dec. 15, 2020 /PRNewswire/ -- While the pharmaceutical industry has had an amazing record of developing therapeutic drugs for countless uses, sometimes, a remaining part of the problem is how do you get the drug into the patient's body? The simplest way is usually to administer the drug orally. Orally administered drugs can be conveniently stored and are portable, economical, noninvasive, and safe. No special training is required for the administration of these drugs as compared to topical formulations… but sometimes, simply taking a pill is not the best route for certain patients, which has given rise to alternative drug delivery systems. Transdermal delivery has benefit of simple application and may be a good alternative to oral delivery in cases when orally administrated drug causes serious side effects. The transdermal route has many attractive properties for the administration of therapeutic agents such as the relative ease of administration and the avoidance of the common problems associated with the oral route. Several recent reports project that the market for these alternative delivery systems has grown in the past few years and is expected to continue to grow over the next several years. Active biotech companies in the markets this week include Nutriband Inc. (OTCQB: NTRB), Rubius Therapeutics, Inc. (NASDAQ: RUBY), Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN), Arbutus Biopharma Corporation (NASDAQ: ABUS), Evelo Biosciences, Inc. (NASDAQ: EVLO).
A recent report form Adriot Market Research said that the global transdermal drug delivery system market is projected to reach USD $8,117 million by 2028, growing at a CAGR of 4.7%. Enhancing bioavailability via bypassing first pass metabolism, improving tolerability and dosing, minimizing pharmaco-kinetic peaks and troughs and increasing patient compliance in continuous delivery are some of the factors driving the growth of the global transdermal drug delivery system (TDDS) market. It said that: "Transdermal drug delivery systems offer several important advantages over more traditional approaches, including longer duration of action resulting in a reduction in dosing frequency, increased convenience to administer drugs which would otherwise require frequent dosing, improved bioavailability, more uniform plasma levels, reduced side effects and improved therapy due to maintenance of plasma levels up to the end of the dosing interval, flexibility of terminating the drug administration by simply removing the patch from the skin, improved patient compliance and comfort via non-invasive, painless and simple application. Moreover, itching, and local edema can be caused by the drug, the adhesive, or other excipients in the patch formulation may hinder the market growth."
Nutriband Inc. (OTCQB: NTRB) BREAKING NEWS: Nutriband Inc. Signs Exclusive License Agreement with RAMBAM Hospital Group for its Closed System Transfer Device – Nutriband Inc., a Nevada Corporation, announced that it signed an exclusive license agreement with RAMBAM Med Tech Ltd, a Division of the RAMBAM Hospital, the largest medical center in Northern Israel, for its Closed System Transfer Device designed to liquify drugs for patients who cannot swallow solids.
The Closed System Transfer Device or CSTD combines the act of crushing a solid drug, dissolving in liquid and giving to a patient who cannot swallow for various reasons. The single-use device mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system making the delivery technology both safe for patients and medical professionals, particularly when seeking to liquify or dissolve hazardous drugs.
Following the signing of the exclusive license agreement with RAMBAM, the company plans to develop and file for 510K approval in the United States in the coming months.
The licensing of RAMBAM's CSTD device compliments the goal and pipeline of Nutriband Inc., which is to improve safety, comfort, and efficacy for the patient, primarily targeting already approved drugs to improve patient outcomes. Read this and more news for NTRB at https://www.financialnewsmedia.com/news-ntrb
Other recent developments in the medical industry include:
Rubius Therapeutics, Inc. (NASDAQ: RUBY) recently reported third quarter 2020 financial results and provided an overview of operational progress. "Rubius Therapeutics continues to demonstrate strong execution across our pipeline of Red Cell Therapeutics for the treatment of cancer. Our IND filing for RTX-321 included, for the first time, frozen drug substance as part of the manufacturing process, resulting in a truly off-the-shelf cellular therapy with a potential shelf life of up to several years," said Pablo J. Cagnoni, M.D., president and chief executive officer of Rubius Therapeutics. "As we continue to escalate the dose in the RTX-240 solid tumor trial, we are assessing the safety profile and biological effects of RTX-240 on innate and adaptive immune responses. We believe that by demonstrating that RTX-240 is working as intended to induce anti-tumor innate and adaptive immunity, we can unlock the potential of the RED PLATFORM® across our entire pipeline of cancer and autoimmune programs."
As of September 30, 2020, cash, cash equivalents and investments were $207.9 million as compared to $283.3 million as of December 31, 2019, providing Rubius with a cash runway into 2022. During 2020, the Company used $97.1 million of cash to fund operations and $4.5 million to fund capital expenditures, consisting mostly of payments for assets purchased in 2019. In addition, during 2020 the Company drew down the third and final tranche of $25.0 million pursuant to its $75.0 million loan agreement with Solar Capital.
Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) recently announced that the European Commission (EC) has approved the new 100 mg/mL intravenous (IV) formulation of ULTOMIRIS® (ravulizumab) for the treatment of two ultra-rare diseases – paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). ULTOMIRIS is the first and only long-acting C5 inhibitor administered to patients every eight weeks or every four weeks for pediatric patients less than 20 kg. ULTOMIRIS 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL, while delivering comparable safety and efficacy. With ULTOMIRIS 100 mg/mL, most patients will spend six hours or less a year receiving treatment.
"ULTOMIRIS has already provided patients with greater flexibility and this new formulation is another step forward in reducing the overall treatment burden," said Professor Alexander Röth, Department of Hematology and Stem Cell Transplantation, University Hospital Essen, Essen, Germany. "With this new formulation, patients will experience comparable safety and efficacy to the original formulation while spending significantly less time per year receiving treatment, which has the potential to make a meaningful difference in their lives."
Arbutus Biopharma Corporation (NASDAQ: ABUS) recently announced additional clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound. William Collier, President and Chief Executive Officer of Arbutus, stated, "Throughout 2020, Arbutus has reported data that demonstrate the robust safety and efficacy of AB-729 in multiple patient cohorts. These data support advancing AB-729 into phase 2a clinical studies in 2021 and further support our confidence in its potential to become a cornerstone drug in future combination regimens to cure chronic hepatitis B."
Dr. Gaston Picchio, Chief Development Officer of Arbutus, commented, "The mean reduction in HBsAg seen at week 16 in Cohort F suggests that AB-729 could offer patients the advantage of being dosed every 8 weeks versus every 4 weeks. Further dosing should allow us to confirm this finding." Dr. Picchio added, "Importantly, safety continues to be unremarkable. We have not seen any related Grade 3/4 AEs or treatment-related discontinuations in any cohorts to date. In Cohort F, two subjects had asymptomatic ALT elevations not considered AEs; one subject with Grade 1 ALT elevations prior to trial entry has had intermittent Grade 2 elevations, while another subject had a transient Grade 1 elevation which resolved with continued treatment.
Evelo Biosciences, Inc. (NASDAQ: EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines which act in the small intestine with systemic effects, recently announced that it is prioritizing EDP1908 as its lead clinical candidate in oncology given its superior preclinical activity over EDP1503. The Company will halt patient recruitment in the Phase 1/2 clinical trial of EDP1503 and will wind down the study. The Company also announced that additional interim clinical data from its Phase 1/2 open-label study evaluating EDP1503 in combination with pembrolizumab in patients with triple-negative breast cancer (TNBC) were presented today in a poster session at the San Antonio Breast Cancer Symposium (SABCS) 2020 Virtual Meeting. The presentation showed that as of a cutoff date of October 30, 2020, EDP1503 was well-tolerated, with an overall response rate (ORR) of 17 percent and a disease control rate (DCR) of 25% in the 12 patients who received the higher dose of EDP1503. These results suggest that the small intestinal axis, SINTAX™, has the potential to be targeted with oral, gut-restricted medicines.
"The EDP1908 preclinical data presented last month at the Society for Immunotherapy for Cancer (SITC) meeting showed that orally administered bacterial extracellular vesicles (EV) showed encouraging preclinical activity without systemic distribution. Based on the strength of the preclinical results from EDP1908 compared to those we observed during our early development of EDP1503, combined with the EDP1503 clinical results, we have decided to focus on advancing EDP1908 as our lead oncology product candidate," said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. "EVs may offer oncology patients better outcomes and serve as the foundation of a new class of potentially safe, effective, and affordable immuno-oncology medicines. We are now scaling up manufacturing in order to advance EDP1908 into the clinic in the first half of 2022."
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