Rebiotix Treats First Patient in Phase 1 Study of RBX7455, an Orally Delivered Broad-Spectrum Non-Frozen MicrobiotaROSEVILLE, Minn., Jan. 4, 2017
Rebiotix Inc., a clinical-stage biotechnology company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that the first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection.
RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format.
RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.
This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home.
RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.
“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”
The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH™ CD2).
“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. ”
RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”
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These techniques shown here include many such acupressure techniques, and are both effective and practical. The practices described are not only great for relieving emotional distress, and help to relieve pain and tension, strengthen the immune system, and improve blood circulation.
Different types of holistic therapy, including massages, have even been reported to help with past emotional traumas.
Massages not only feel tremendous, but they’re useful in reducing stress – both in body and in mind. The techniques introduced here are intended to help relieve stress and anxiety, two emotions that nearly everyone is familiar with.
When practicing the techniques described, apply pressure to noted areas over a three (3) minute interval unless otherwise noted.
Chinese practitioners, in addition to a number of others, believe in an inseparable mind and body connection. While the five techniques described have “different” purposes (affected areas of the body), the cumulative result is a notable improvement in mood, including the alleviation of stress, anxiety, tension and a host of other psychological and physical benefits.
When utilizing these exercises try to focus more on overall well-being of body and mind rather than relief of “separate” ailments.
It is our sincere hope that the technique is useful and practical in everyday lives.
Please Note: Exercise Instructions to “apply pressure” indicates the use of fingers, thumb, palms, knuckles and sides of the hand. Ensure that when pressure is applied that it is firm, but not so firm that it results in anything beyond very slight pressure.
Technique 1 (for relief of nausea): Locate the point of the arm three finger-lengths up from the forearm beginning at the wrist. In this spot, apply a firm amount of pressure by rotating the tip of the thumb for about 2 to 3 minutes.
Technique 2 (for relief of both stress and tension): The next are is located in the webbed area of the hand, between the thumb and index finger. Using the opposite hand’s thumb and index finger, apply firm pressure on both sides of the webbing for about 2 to 3 minutes while taking slow deep breaths.
Technique 3 (for improved energy and alleviation of exhaustion): In the shoulder, also known as the trapezius area, Apply firm pressure to the area halfway between the shoulder and base of the neck. Perform a circular motion for about 2 minutes and switch to the other side.
Technique 4 (for increased blood flow and relaxation): In an area located approximately two finger-widths above where the arms meet the chest (around the rotator cuff area), apply firm pressure. This will help to increase blood flow and invoke feelings of relaxation.
Technique 5 (for relief of insomnia, stiffness, and exhaustion): The final area is located one finger-width below the base of the skull on either side of the spine. The best practice for applying firm pressure in this area is to wrap the fingers around the back of the skull and use the thumbs to apply pressure. Stimulate this area while taking slow deep breaths and closing the eyes. The three minute (3) massaging at this location is said to help with relieving exhaustion, stiffness and insomnia.
A brief video demonstrating Self Massage Techniques for Neck and Shoulder: