PR NewswireZUG, Switzerland and NEW YORK, March 29, 2016
ZUG, Switzerland and NEW YORK, March 29, 2016 /PRNewswire/ — #SELLAS Life Sciences Group (SELLAS), a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancers and central nervous system (CNS) diseases, today announced that the United States Adopted Names Council of the American Medical Association has approved the use of the United States Adopted Name (USAN) galinpepimut-S for SELLAS’s WT1 #vaccine.
The WT1 vaccine is a late clinical-stage #cancer #immunotherapy being developed to target hematologic cancers and solid tumors, including acute myeloid leukemia (AML), mesothelioma (MPM), multiple myeloma, ovarian cancer, and multiple other cancers. SELLAS recently reported positive results of a Phase 2 trial of its WT1 vaccine in MPM patients, showing that overall survival improved and progression-free survival doubled. Based on these findings, SELLAS intends to initiate a pivotal Phase 2b/3 trial of its product #candidate in patients with MPM by the third quarter of 2016.
In addition, the Company expects to begin a pivotal Phase 3 Study of its WT1 vaccine in AML patients by the second quarter of 2016. A median overall survival of around 4 years was achieved in a Phase 2 trial of the WT1 vaccine in adult patients with AML. Similarly, in a previous Phase 1 AML study, the WT1 vaccine resulted in a median overall survival of more than 3 years. When combined, the results from the Phase 1 and Phase 2 studies demonstrated a 2-year overall survival in adult AML patients of 79%. Historical 2-year overall survival results in similar patient populations range from 30% to 45%.
“We expect 2016 to be an exceptional year for the progress of our advanced-stage WT1 program,” said Miltiadis Sougioultzoglou, M.D., Vice Chairman and Executive Vice President of SELLAS. “Over the course of the next three quarters, we anticipate announcing the start of two pivotal studies, in MPM and AML, as well as multiple Phase 2 studies in additional solid tumors and hematological malignancies. We also expect to have a steady flow of clinical trial readouts from this program in 2016 and 2017, with the intention of demonstrating the potential of the WT1 vaccine in diverse indications where there is compelling clinical need.”
About SELLAS’s WT1 Cancer Vaccine
SELLAS’ WT1 vaccine is a late clinical-stage cancer immunotherapy being developed to target hematologic cancers and solid tumors, including acute myeloid leukemia (AML), mesothelioma (MPM), multiple myeloma, ovarian cancer, and multiple other cancers. The WT1 antigen is a transcription factor that is not generally expressed in normal adult cells, but appears in a large number of cancers, as well as in certain cancer stem cells. WT1 has been ranked by the National Cancer Institute (NCI) as the Number 1 target for cancer immunotherapy. While WT1 has not been druggable by traditional approaches, it can be targeted by the immune system. Specifically, a number of different peptide sequences from the WT1 antigen have been identified as immunogenic and capable of stimulating cytotoxic T-cells that can target and kill WT1-expressing cancer cells. Studies also have shown that WT1 does not provoke tolerization and that patients’ T-cells can remain reactive to the antigen over time.
The WT1 vaccine, originally developed by Memorial Sloan Kettering Cancer Center and licensed to SELLAS, comprises four modified peptide chains that induce a strong innate immune response (CD4+/CD8+ T-cells) against the WT1 antigen. The WT1 vaccine is administered in combination with an adjuvant and an immune modulator to improve the immune response to the target. Based on its mechanism and the accumulating evidence of activity in mid-stage trials, the WT1 vaccine may have the potential to complement currently available therapies by destroying residual tumor cells of cancers in remission and providing ongoing immune surveillance for recurrent tumors. Overall, SELLAS’ WT1 vaccine could target over 20 cancers that over-express WT1, many of which are associated with relapse rates of up to 80% or more, as seen in patients with AML and MPM.
About The USAN Council
The USAN Council serves health professionals in the United States by selecting simple, informative, and unique nonproprietary names for drugs by establishing logical nomenclature classifications based on pharmacological and/or chemical relationships to ensure that drug information is communicated accurately and unambiguously. The USAN Council aims for global standardization and unification of drug nomenclature by working closely with the International Nonproprietary Name Programme of WHO and various national nomenclature groups.
About SELLAS Life Sciences Group
SELLAS Life Sciences is a development-stage biopharmaceutical company focused on innovative products to treat cancer and central nervous system (CNS) diseases. SELLAS has two Phase 2b- and 3-ready products poised to enter trials in Europe and the US in 2016, across multiple indications in cancer and CNS diseases, as well as an earlier-stage highly innovative cancer therapeutic. The company recently received orphan drug designations by the US FDA for its WT1 cancer vaccine in Acute Myeloid Leukemia and Malignant Pleural Mesothelioma which will enter into pivotal clinical trials in 2016.
SELLAS’s WT1 vaccine, licensed from Memorial Sloan Kettering Cancer Center, is a cancer immunotherapeutic agent targeting a broad spectrum of hematologic cancers and solid tumor indications. This program will advance into Phase 3 trials in 2016 in AML and MPM as well as other indications in various development phases, including ovarian cancer, glioblastoma multiforme, and others with WT1 vaccine alone or in combination with other immunooncology agents. SELLAS is also advancing a proprietary formulation of high-dose Zolpidem under the 505(b)(2) pathway to treat basal ganglia disorders, including Parkinson’s disease and Progressive Supranuclear Palsy (PSP), which is the lead orphan indication. Zolpidem’s mechanism of action and therapeutic effects in such CNS-related diseases have been demonstrated in several studies. SELLAS expects to initiate a Phase 2b study of high-dose Zolpidem for PSP in 1H 2016. A third program is focused on SELLAS’s TR1 product candidate, a novel fusion protein that supplies the normal wild type p53/p21 protein to cancer cells to trigger innate cell death mechanisms (apoptosis). The Company is advancing its TR1 program toward IND-enabling studies, with the goal of commencing Phase 1 testing by early 2017.
SELLAS was founded in 2012 and is headquartered in Zug, Switzerland, with additional offices in New York, USA.
Ami Bavishi, Burns McClellan, +1 (212) 213-0006, firstname.lastname@example.org
David Moser, J.D., + 1 (813) 864-2571, Dmoser@sellaslife.com
Justin Jackson, Burns McClellan, +1 (212) 213-0006, email@example.com
SOURCE SELLAS Life Sciences Group
Kombucha Starter Kit
You Can Do It YourselfCommercially-produced kombucha is widely available today and can be found in most supermarkets and health food stores. However, it’s actually easy to make your own fizzy kombucha beverage right at home using only a few necessary ingredients.. All you need is: • A large clean glass jar • Green or black tea • Sugar • Water • Wooden spoon • A coffee filter or cheese cloth • A rubber band • 1 SCOBY (symbiotic culture of bacteria and yeast) The SCOBY is responsible for the fermentation and production of healthy probiotic bacteria. You can purchase a SCOBY online or ask a friend who already makes their own kombucha. After that, it’s as easy as following a few simple steps until you’ve got your own homemade kombucha tea beverage.
[table id=1 /] By reducing the amount of chemicals entering the body we reduce disease and disorders.
Personal Experiences ....Frau T. S. from P., Germany, writes: "I have had it (the Kombucha tradition) for 6 months now, and my well being is bettering at all times, In short, I believe nice. I additionally handed it directly to buddies who're additionally more than happy with it and feature been cured of rheumatic pains and liver court cases, for instance.(...) I would not love to must surrender consuming the beverage." "Since consuming Kombucha Tea I've spotted a drastic aid within the signs of HAY FEVER AND SINUS that I have been experiencing. I've a big VARICOSE VEIN on my proper calf All over the time I've been consuming the Kombucha Tea, I've spotted that it's been shriveled and it does now not itch or pain because it used to. I actually have a SENSITIVE STOMACH which has been relieved, and I'm additionally in a position to deal with REGULAR BOWEL ACTIVITY."
Mr H. Wilkins... Springwood, Qld.
"For about 17 years I have been affected by serious MIGRAINE HEADACHES, no less than thrice per week at a minimal. I used to be completely resigned to the truth that I'd proceed to be afflicted by this criticism and ache for the remainder of my fife. When visiting some buddies one night time I used to be requested if I would really like to take a look at one of the most " MIRACLE" drink referred to as Kombucha Tea. I used to be hesitant, however I did take a look at it anyway. It tasted fairly refreshing, however unknown to my buddies I had a ache in my higher gastric area which have been there many of the day. To my astonishment, inside part an hour of consuming this Kombucha Tea my ache had completely disappeared. After starting up to drink this tea two times day-to-day for the closing two and a part months I HAVE NEVER EXPERIENCED ONE MIGRAINE AT ALL. I'm so extremely joyful so to percentage this enjoy and inform other folks how this Kombucha Tea has benefited me and CHANGED MY LIFE."
Fay Haddrill ... French's Wooded area
Kombucha Tea is a fermented drink made with tea, sugar, bacteria and yeast. Although it’s sometimes referred to as kombucha mushroom tea, kombucha is not a mushroom — it is a colony of bacteria and yeast. Kombucha tea is made by adding the colony to sugar and tea, and allowing the mix to ferment. Kombuca Tea has been taken for its natural probiotic healing properties for thousands of years and due to recent information provided by RainTree Nutrition and The National Health Sciences Institute, there has been tremendous excitement to take this ancient elixir. Kombuca Tea is a powerful herbal supplement that the Shaolin Monks and Eastern Mystics have used for centuries to strengthen the body’s natural defenses including memory problems, premenstrual syndrome (PMS), joint pain and rheumatism, appetite loss, high blood pressure, constipation, arthritis, hair growth, immunity issues and cancer. Kombucha Tea can be brewed in your home with a Kombucha SCOBY. It produces a sweet, slightly sour Elixir that you can drink at anytime. Kombucha (formal name: Medusomyces gisevii, also called tea mushroom and manchurian mushroom) is a variety of fermented, lightly effervescent sweetened black or green tea drinks that are commonly intended as functional beverages for their supposed health benefits. Kombucha is produced by fermenting tea using a “symbiotic ‘colony’ of bacteria and yeast” (SCOBY). What makes Kombucha Tea so unique is its wide variety of bioactive phytonutrients, which work naturally at the cellular and systemic levels.
Boost Your Immune SystemThose who love to look for natural health remedies will love the fact that kombucha is actually a natural antibiotic. This is because of the process of fermentation and its by-products. One of which is acetic acid, which creates a kind of sterile environment which inhibits the growth of unhealthy bacteria. The probiotics also fight the bad bacteria so whereas pharmaceutical antibiotics kill off all the bacteria in our systems, kombucha leaves the good and kills the bad. No bad bacteria means no infections which equals a healthy, happy immune system!
Helps With DigestionSpeaking of those probiotics…kombucha is full of healthy bacteria that do plenty of good for our bodily functions. One of kombucha's primary benefits is that its probiotics, yeasts, and enzymes help with digestion by breaking down food for better nutrient absorption. They also promote the growth of healthy gut flora, which help us to digest our food better and maintain a healthy pH level. Your gut also gets a break because it doesn’t have to work as hard to break down fermented foods because the bacteria have already done some of the work.
It’s AlcoholicIf you’re familiar with the brewing processes of beer, wine, or spirits, you’ll know that fermentation involves alcohol. This is because as the yeast breaks down the sugar, they release two things: carbon dioxide and ethanol (aka: bubbles and booze.) The level of alcohol is fairly low because the fermentation time isn’t that long and while commercially made kombucha beverages have found ways to reduce their alcohol content in order to comply with sales regulations, if you brew a batch at home there will definitely be some alcohol present. Something to keep in mind for pregnant or nursing mother
Kombucha Cocktails Anyone?Here’s a fun fact: kombucha can be used to make cocktails! Not as the alcohol component, but rather as the mixer. Its sweet, sour, tangy flavor makes it a perfect compliment to your favorite spirit and can be used to make drinks such as a Kombucha-Rita (kombucha, ice, lime juice and taquila), Kombucha Sour (kombucha, whisky and lemon juice), or a kombucha version of a Shandy (half beer and half kombucha.) Furthermore, when you make your cocktails with kombucha rather than soda, you’re less likely to experience that dreaded hangover! This is because the antioxidants and detoxifying properties help combat the symptoms that lead to that terrible morning after feeling.
Loaded With B and C VitaminsIn addition to being full of many other beneficial nutrients, kombucha is loaded with Vitamins B and C, both of which are essential for optimum health. Vitamin B helps to ease stress levels, curb sugar cravings, lower your risk of heart disease, and help memory functions. It’s clear that B vitamins are pretty powerful, but those C vitamins present in kombucha have their own set of benefits. Among them are increasing the strength of the immune system, reduced risk of cardiovascular disease and playing an important part in the improvement of eye health. That’s a lot of benefits in one bubbly beverage!
It Can Help With Stomach IssuesWe mentioned before in the digestion slide that kombucha is more easily digested. We mentioned before in the digestion slide that kombucha is very easily digested. This is because the fermentation helps to pre-digest some of the enzymes, which means your pancreas doesn’t need to work as hard or secrete as much digestive fluid. Kombucha also helps to achieve a healthy PH balance in the gut and promotes the growth of healthy bacteria. For these reasons, the beverage has been known to help those suffering with stomach issues such as Irritable Bowl Syndrome, Crohn’s Disease, Celiac Disease, and Candida overgrowth. It Strengthens Your Stomach Walls Another component of kombucha is a substance called Butyric Acid, which is another by-product of the fermentation process. Butyric Acid is known to have antimicrobial and anti-carcinogenic properties as well as being known to strengthen the walls of your gut, kill parasites and protect against yeast infections. It’s an interesting substance that promotes overall digestive health from the inside out.
It Strengthens Your Stomach WallsAnother component of kombucha is a substance called Butyric Acid, which is another by-product of the fermentation process. Butyric Acid is known to have antimicrobial and anti-carcinogenic properties as well as being known to strengthen the walls of your gut, kill parasites and protect against yeast infections. It’s an interesting substance that promotes overall digestive health from the inside out.
It Helps With Joint HealthYou may have heard of the amino sugar called Glucosamine, you may even give it to your elderly pets (or family members) to help with stiff or sore joints. In fact, glucosamine is one of the most common non-vitamin, non-mineral supplements used by adults in the USA today. Another amazing fact about kombucha is that it contains naturally occurring glucosamine which means this drink can help keep your joints healthy and moving correctly and even prevent arthritis. This is an especially appealing aspect for athletes who need to keep their bodies in top shape for as long as possible. It’s no secret that antioxidants are good for you. They neutralize free radicals in our bodies, which can cause cell damage relating to cardiovascular disease, cancer and other ailments.
The best sources of antioxidants are fruits and vegetables but Kombucha is also full of these hard working little compounds which means that kombucha actually has detoxifying properties, which can help cleanse the liver and prevent cancer.
Kombucha is a variety of fermented, lightly effervescent sweetened black or green tea drinks that are commonly intended as functional beverages for their supposed health benefits. Kombucha is produced by fermenting tea using a “symbiotic ‘colony’ of bacteria and yeast” (SCOBY). Actual contributing microbial populations in SCOBY cultures vary, but the yeast component generally includes Saccharomyces and other species, and the bacterial component almost always includes Gluconacetobacter xylinus to oxidize yeast-produced alcohols to acetic and other acids.
Kombucha originated in what is now Manchuria around 220 BCE, and is said to have been imported to Japan around 400 CE by the physician Kombu. It is commonly It is commonly drunk in the United States.
Kombucha is a variety of fermented, lightly effervescent sweetened black or green tea drinks that are commonly intended as functional beverages for their supposed health benefits. Kombucha is produced by fermenting tea using a "symbiotic 'colony' of bacteria and yeast" (SCOBY). Actual contributing microbial populations in SCOBY cultures vary, but the yeast component generally includes Saccharomyces and other species, and the bacterial component almost always includes Gluconacetobacter xylinus to oxidize yeast-produced alcohols to acetic and other acids.