The Food and Drug Administration said Thursday in a letter that it has approved remdesivir as a treatment for coronavirus patients.
It had been authorized for use on an emergency basis since spring and now has become the first drug to win full U.S. approval for treating COVID-19.
Ionis’ third novel antisense medicine for ALS, its first designed to treat a broad ALS population, begins clinical trial
CARLSBAD, Calif., Oct. 22, 2020 /PRNewswire/ — Ionis Pharmaceuticals, Inc. (NASDAQ: IONS), the leader in antisense therapeutics, today announced that the first patients have been dosed with ION541 (also known as BIIB105), an investigational antisense medicine being developed as a potential therapy to treat most forms of amyotrophic lateral sclerosis (ALS) regardless of family history. This is another milestone in the continuing progress of Ionis’ ambitious program to develop novel treatments for ALS. Almost all cases of ALS share the pathological hallmark of TDP-43 protein aggregation in motor neurons. ION541 targets ataxin-2 RNA (ATXN2), which has been shown to prevent or reverse TDP-43 toxicity in preclinical models of ALS.
ALS is a rare, progressive and fatal neurodegenerative disorder that affects approximately 55,000 people globally.i About 90 percent of ALS cases occur in people who have no apparent family history of the disease. People with ALS experience muscle weakness, loss of movement, and difficulty breathing and swallowing, resulting in a severely declining quality of life and potentially death.
“As our third medicine designed to treat different forms of ALS to enter clinical trials, ION541 represents yet another example of the power of Ionis’ antisense technology to potentially target root causes of devastating neurodegenerative diseases,” said Frank Bennett, Ph.D., Ionis’ chief scientific officer and franchise leader for neurological programs. “Initiation of this clinical trial for ION541 marks an important milestone in Ionis’ ALS program and reaffirms our commitment to the ALS community.”
Ionis received a payment of $10 million from Biogen for initiation of this Phase 1/2 clinical trial of ION541. Biogen is developing ION541 as part of a broad strategic collaboration with Ionis to advance novel antisense therapies for the treatment of neurological disorders.
Learn more about the Phase 1/2 trial of ION541 at: https://clinicaltrials.gov/ct2/show/NCT04494256?term=biib105&draw=2&rank=1
Ionis’ other leading investigational medicines to treat ALS are tofersen (BIIB067) and IONIS-C9Rx (BIIB078), both partnered with Biogen. Tofersen is designed to reduce the production of superoxide dismutase 1 (SOD1), the cause of a genetic form of ALS, referred to as SOD1-ALS, that results from mutations in the SOD1 gene. SOD1-ALS is the second most common genetic form of ALS, accounting for up to 20 percent of genetic ALS. Tofersen is currently in a Phase 3 clinical trial in SOD1-ALS patients with data expected in 2021. IONIS-C9Rx is designed to selectively reduce the mutant C9ORF72 RNA and associated neurotoxicity. Mutations in the C9orf72 gene account for greater than 30 percent of genetic ALS cases and five to 10 percent of all patients with ALS. It is the most common genetic form of ALS worldwide. IONIS-C9Rx is the first drug to enter clinical development that specifically targets the mutant C9ORF72 RNA and is a potentially first-in-class therapy for patients with C9orf72-ALS, referred to as C9-ALS. IONIS-C9Rx, which earlier this year received Fast Track designation from the U.S. Food and Drug Administration, is currently in a Phase 1/2 trial in C9-ALS patients.
Ionis’ Forward-looking Statement
This press release includes forward-looking
Keck Medicine of USC enrolling individuals in phase 3 clinical trial to treat mild Alzheimer’s disease using deep brain stimulation
LOS ANGELES — An estimated 5.5 million people in the United States live with Alzheimer’s disease, which is the most common form of dementia.
Keck Medicine of USC is enrolling individuals in an international phase 3 clinical trial to examine the safety and effectiveness of deep brain stimulation to treat Alzheimer’s. The study uses electrical impulses to stimulate the region of the brain known as the fornix, which is associated with memory and learning.
“Deep brain stimulation has successfully treated conditions such as Parkinson’s disease by improving motor skills, and we are now investigating if this therapy can stabilize or improve cognitive function,” says Darrin Lee, MD, PhD, a neurosurgeon with Keck Medicine of USC and the site’s principal investigator of the study. “Based on the results of earlier phases of this clinical trial, the treatment offers a potential benefit for patients with mild Alzheimer’s.”
This randomized, double-blind study will last four years. Subjects will first take a standardized assessment test for Alzheimer’s to be used as a baseline measure of cognitive ability throughout the study.
Next, researchers will implant electrodes into subjects’ brains that connect to a battery pack, similar to a heart pacemaker, placed underneath the collarbone.
For the first year of the study, subjects will be given either low-frequency stimulation to the brain, high-frequency stimulation or a placebo — no stimulation.
“For those with Alzheimer’s disease, certain parts of the brain become atrophied,” Lee says. “We are testing to see if stimulating the brain’s fornix can reawaken brain activity in this area and stop the progression of the disease.”
During the first year, subjects will be given subsequent cognitive tests to check if their memory or learning skills have held steady or improved. At the end of the year, study researchers will examine data to determine which level of stimulation had the most impact on these skills.
For the next three years of the trial, all subjects in the study will receive what researchers have determined is the optimal frequency of deep brain stimulation, even those originally receiving the placebo. Patients will continue to be given cognitive assessments throughout the four-year period.
To qualify for the trial, patients must be 65 or older, have been diagnosed with mild Alzheimer’s and take Alzheimer’s medication, and have a caregiver or family member who can accompany them to doctor visits.
The clinical trial involves approximately 200 patients at some 20 sites in the United States, Canada and Germany. Keck Medicine plans to enroll 8-15 patients.
The trial is sponsored by Functional Neuromodulation, Inc.
Those interested in enrolling in the clinical trial with Keck Medicine can contact Amanda Romano at [email protected] or 213-393-5640.
Keck Medicine co-investigators of the trial include psychiatrist Carlos Manuel Figueroa, MD, and neurologist Elizabeth Joe, MD.
Deep brain stimulation has been
Holistic Cancer Treatments
The best way to fight cancer is to not get cancer in the first place. "Easier said than done," you say. "My family has a history of cancer," you say. "Three of my friends just got cancer," you say.
This is a story I have heard many times, as, probably, have you. So how do you deal with this?
Let's take the first scenario: "My family has a history of cancer." Well, your family's history of cancer just means you need to educate yourself on the causes of cancer. Is cancer hereditary? No, it is not. Isn't there a certain gene that makes me susceptible to cancer? That has not been proven to date. What about what doctors are telling me? Unless they are cancer specialists, I would get more than one opinion.
There are many Holistic Cancer Treatments out there for you to investigate. These I have found to work for my clients.
Maintaining a proper balance in the body's pH can have a positive effect on all major body systems, including your digestive, circulatory, respiratory and immune systems. This balance promotes more oxygen affinity in the blood, thus allowing the body to function properly.
So what can we do to start to eat and live healthy? I'm going mention smoking smoking here, but that's all. You know who you are – stop smoking! The next biggest cancer threat in my opinion is soda. It is about the most acidic drink you can get. You all know that I am an alkaline water advocate. I drink between 50 and 90 ounces of alkaline water a day, but not as much as recommended by doctors who advocate alkaline water. However, if I drink one 12-ounce can of soda – diet or otherwise does not make a difference – I have to drink 400 ounces of alkaline water just to get my body back to the pH it was before drinking that one soda.
Having an acidic body greatly lowers your immune system, making you susceptible to disease and of course cancer, depending upon your other eating and drinking habits.
Back in 2011 My Ex-Wife Judy was diagnosed with Colon Cancer. I got a call from my Son Kris in California who let me know. Judy had Breast Cancer in 2002 and had a mastectomy and Chemo and Radiation Treatments. I met with Judy and her Husband Doug and let them know of the health benefits of Alkaline Water. Judy started drinking 2.5 gallons of 9.5 ph. alkaline water a week. She did this for over one year. She had the tumor removed on her colon but refused chemo and radiation as it was hard on her body and immune system the last time around. Judy is Cancer free today.
Here are some foods to make your body more alkaline: lemons, watermelon, limes, grapefruit, mangos and papayas. Frozen lemons grated over salads or hot cereals are great and very alkaline. Use the whole lemon when freezing. This is …
Chinese Medicine believes that there are several types of tinnitus. These are related to different energetic issues associated with the energy flow and proper function of several organs including the kidney, liver, and gallbladder. There are always several ways that Traditional Chinese Medicine can repair a symptom or disease. The ancient art of Tuina can be used to relieve hearing loss and tinnitus. Tuina is oriental body work that may seem similar to massage with hard pressure hand movements on muscles or tendons combined with acupressure. Medical Qi Gong may also heal tinnitus for some people. Auricular acupuncture and scalp acupuncture are other options for treat tinnitus in Traditional Chinese Medicine. Moxa may be added as part of an overall treatment plan.
It is important to look at other factors which can cause or contribute to hearing loss and tinnitus. Heavy metal toxins can be a very big factor. These should have diagnostic testing and be treated with oral chelation or IV chelation in very severe cases. Oral chelation requires a longer period of time and is more gentle on the body. IV chelation requires electrolyte supplementation. It is important to have vitamin and antioxidants to support the body when undergoing any type of chelation. Carbonated beverages or beer may be connected with higher levels of aluminum in your body. Cigarettes may also contribute to ear ringing. Chelation may require four to nine months for the detoxification of heavy metals and toxins from your body. The use of far infrared sauna during this time can speed your detoxification process. Do not do more than two per week when taking chelation therapy. It is also important to drink pure water and flush your kidneys during this time.
Chinese Patent formulas that are useful in treating this disease include:
• Wai Gan Fen Re Xing (respiratory infection),
• Er Long Zuo Ci Wan (for aging of kidney and liver)
• Shen Jing Shai Ruo Wan (for insomnia, fatigue, insomnia, and tinnitus)
• Jiang Ya Wan (for dizziness, hypertension, and tinnitus)
• Da Bu Yin Wan (for nights sweats, hyperthyroidism, and tinnitus)
• An Shen Bu Xin Wan (for insomnia, memory, palpitations, and tinnitus)
• Shen jing Kui Xu Xing (kidney dysfunction)
• Pi Qi Xu Ruo Xing (abnormal spleen function)
The Japanese herbal formula Yoku-kan-san may be useful in treating tinnitus.
The addition of scalp acupuncture is great and may speed the healing process if the tinnitus is due to a deficiency condition. If the problem is an excess condition, body acupuncture and asian bodywork may be more effective. Try medical qi gong and qi gong for healing tinnitus, hearing loss, and eye problems.
© Dr R Stone, MD-India
Trichotillomania is an impulse control or brain disease similar to OCD or addiction where the person pulls out their own hair. The hair can be located anywhere. Trichotillamania may be caused by trauma, rape, physical violence, torture, child abuse, and very severe emotional abuse. It may be minor and easily managed or severe. This disease can overwhelm the person. It is very important for the person with this disease to eliminate or minimize exposure to any severely negative people in their life that are abusive or exploitative. It is an emotional disorder that usually needs several therapies in order to be managed successfully. There are many alternative therapies which are untried for this illness, but these may successful due to the large emotional component of the illness. Trichotillomania seems similar to addiction, OCD, and a bad habit. Quieting the mind should be one of the goals of any therapy. Alternative therapies that quiet the mind include Yoga, scalp acupuncture, auricular acupuncture, Emotional Freedom Technique (EFT), botanical extracts, Transcranial Magnetic Stimulation (TMS), and orthomolecular medicine.
This person must be evaluated by a medical professional. A full physical and diagnostic testing of hormones and neurotransmitters must occur. This patient must be evaluated for AIDS and a brain tumor. There are several diseases that are severe enough to result in very irregular symptoms. It is extremely important to be very aggressive in treating this disease. Amino acids therapy for this may be useful and could include 5-HTP, theanine, GABA, and phenylalanine. Chinese herbal patent formulas may be considered along with Chinese liquid herbal extracts. Scalp acupuncture may be very successful in treating this type of illness. It should be done with larger needles for this type of disease. Scalp acupuncture treatments last about thirty minutes to one hour. It may take nine treatments in order to see results. Laser therapy using a cold medical grade laser may work well on this patient. You may need several sessions of cold medical grade laser therapy before you see a significant change.
It is important for this person to sleep well and eat a well balanced diet without nitrates, amines, and food dyes. This person should avoid genetically modified foods, food additives, MSG, tumeric, and drink plenty of pure water to stay fully hydrated. The diet should allow Swiss method decaffeinated coffee or organic coffee and tea. This person should consider trying the Rotation Diet where each food may be eaten once during a four-day period. It is also a good idea to identify and reduce exposure to all allergens. You may want to consider some form of allergy treatment. Convention allergy treatments with shots is one alternative. NAET is a non-painful alternative that incorporates chiropractic and acupuncture with a special diet to treat allergens. This person needs consider a form of regular exercise like the walking, gym, biking, Bikram yoga, hiking, and dancing.
© Dr R Stone, MD-India
People don't often think to consult their dentist for treatment of migraines and other chronic headaches, neck aches and facial pain, but they should.
These debilitating symptoms often are the result of temporomandibular joint disorder- commonly referred to as TMJ-a jaw alignment and bite disorder that can be treated through neuromuscular dentistry.
The TMJ is the ball-and-socket joint on each side of the head where the lower jawbone joins the temporal bone of the skull, according to mayoclinic.com/health/tmj-disorders/DS00355
The lower jaw has rounded ends that glide in and out of the joint socket when talking, chewing or yawning.
Between five percent and 15 percent of people in the United States experience pain associated with TMJ disorders, according to the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health. Women are more likely than men to develop TMJ disorders.
In most cases, pain and discomfort associated with TMJ disorders can be treated through self-managed care or non-surgical treatments, said Dr. Mindy Munowitz, a dentist who specializes in neuromuscular and cosmetic dentistry in Cincinnati, Ohio. However, more severe cases may require further dental or surgical treatment.
While traditional dentistry evaluates primarily the teeth, bones and gums, neuromuscular dentistry works with the hard tissues and the soft tissues, muscles and nerves, according to leadingdentists.com/what_is_neuromuscular/what_is_neuromuscular_dent.html the Las Vegas Institute for Advanced Dental Studies Web site.
Typically, the treatment follows three steps. The first is to relieve the pain of muscle spasms and the overall discomfort of TMJ symptoms.
"Patients suffering from TMJ are looking for relief of the symptoms," Munowitz said. "We are successful in doing this through non-surgical neuromuscular dentistry methods."
The best way to do this is by using technology called Ultra Low Frequency Transcutaneous Electrical Neural Stimulation, or ULF-TENS. Simply put, this stimulation emits pulses to gently massage the jaw muscles and relax them. ULF-TENS relieves the pain by stimulating the body's production of endorphins, the body's natural anesthetic.
The next step is to stabilize the patient's bite. This is accomplished using an orthotic, which is worn over the teeth.
"The orthotic allows me to make easy adjustments to the plastic without adjusting the teeth until the bite is stabilized," Munowitz said.
There are several amino acids involved in treating erectile dysfunction. Four amino acids that treat this disorder are arginine, orthinine, L-carntitine, and glycine. Treating erectile dysfunction with amino acids is called orthomolecular medicine. Orthomolecular medicine is the use of therapeutic levels of amino acids, vitamins, and minerals to treat and cure disease. Dr. Linus Pauling is one of the early pioneers in this field. Dr. Stanislaw Burzinski is another important doctor in orthomolecular medicine. He treats cancer with an orthomolecular based protocol.
Arginine is one of the essential amino acid involved for the production and release of human growth hormone. This hormone is important to immune function, healing, and wellness. Many conditions increase the level of arginine that is required by our bodies. These conditions include trauma, heart conditions, diabetes, physical injury, surgery, obesity, smoking, drug addiction, and alcoholism. Higher levels of arginine are needed for diabetic wound healing. Medical conditions that affect the body's ability to produce enough arginine are anorexia, autoimmune diseases, cancer, heart conditions, diabetes, insufficient food intake due to food shortages, poisoning, severe toxin exposure, HIV, AIDS, hepatitis, burns, broken bones, pregnancy , and post surgical recovery.
Illness, trauma, and emotional distress can produce hormone deficiencies which impact key essential amino acid levels throughout the body. Diabetes, anorexia, pregnancy, stress, trauma, protein deficiency from vegetarian diets, and malnutrition due to drug and alcoholism are conditions that contribute to arginine deficiencies.
Arginine can help weight loss, arthritis, fertility issues, liver disease, many cancers, body building, plastic surgery recovery, low libido, sterility, low sperm count, low sperm motility, and erectile dysfunction.
Arginine is a key anti-aging agent when combined with lysine and proline. Many anti-aging nutritional products contain these three amino acids.
Many foods are rich in arginine including beef, seafood, venison, walnuts, pecans, soybeans, almonds, cashews, wheat, chocolate, and most dairy products. Supplements are found in capsule and tablet form.
Avoid arginine supplementation until you have consulted with a holistic doctor or healthcare provider.
© 2010 by Dr R Stone
If you have been putting off seeing the dentist out of fear, you're not alone. In fact, many patients, both old and young are afraid of the dentist. There are many causes behind people dental fears including unpleasant past experiences, the fear of their poor oral hygiene habits being found out, the fear of the dentist finding something wrong or the unpleasant smells and sounds. Adults can also dread the bill they may be hit with if they don't have good dental insurance and something bad is found.
You may have heard from someone at one time or another to "face your fears" and that the more you do which is uncomfortable for you, the more likely you'll get use to it and it will no longer be scary. The same logic can be applied to visiting the dentist. The more frequently you visit the dentist, the better you'll know your dentist and staff and the more accustomed you'll get to the look, feel, sounds and smells of the dental office.
Patients are highly encouraged to see their dentist at least twice a year, or every six months, for a routine dental examination and professional teeth cleaning. These types of routine appointments are quick, inexpensive (many dental insurance plans cover these check-ups) and don't cause any pain or discomfort or the patient. Sticking to this regular dental office visitation schedule will help you gradually calm the fears and concerns you may have had about going to the dentist. They will also help inform you and your dentist about possible oral health issues that can be easily and effectively treated while in its early stage.
Many dental patients who cave into their fears and don't regularly see their dentist are at a higher risk of having oral health issues that require more intensive, uncomfortable, long, expensive treatment. This can, in turn, reinforce the patient's fear of the dentist by once again giving him or her a negative, unpleasant experience.
Some patients think that because their teeth and gums look and feel great that they don't need to see their dentist. This is a common misconception that often results in patients putting their oral health at unnecessary risks. While some dental issues such as tooth decay and gum disease have symptoms that can be easily noticed by someone with no dental knowledge, other oral conditions such as Bruxism and oral cancer often don't exhibit any noticeable symptoms. Without the examination of the trained eyes of a dental professional, a patient can very well have a potentially life-threatening condition that requires immediate treatment. Even if nothing serious is detected, a dentist can observe and anticipate the growth and development of various oral conditions, something an untrained eye would easily miss. Proactive and preventative dental treatment can then be carried out, sparing the patient from additional pain, discomfort, complications, and costs.
As the old adage goes "prevention is the best medicine." Catching oral health issues early and getting a deep-cleaning teeth cleaning to prevent …