It's been two years since we first announced we'd be launching clinical trials for SCD-101, the drug equivalent of our supplement Xickle RBC-Plus. A necessary part of our journey toward FDA-approval, the initial phase of our clinical trial has already demonstrated the effectiveness of Xickle on patients with sickle cell disease.
In fact, in the December 2016 issue of Blood, the American Society of Hematology’s weekly medical journal, an article was published illustrating the initial successes of our trial. The feature, “SCD-101: A New Anti-Sickling Drug Reduces Pain and Fatigue and Improves Red Blood Cell Shape in Peripheral Blood of Patients with Sickle Cell Disease,” points out that participants in phase one of the trial not only showed reduced occurrences of cell sickling, but also reported an increase in exercise ability, as well as improved sleep and ulcer healing, leading the researchers to conclude that SCD-101 is a “promising new drug for the treatment of sickle cell disease.”
Fast forward a few months, and because of the success of the initial round, we are now preparing to enter the next phase in our dose-escalation study: a randomized, double-blind, placebo-controlled crossover. Here’s how it’ll work: Participants will be randomized to two treatments—placebo and SCD-101. Some will receive 28 days of the placebo first, followed by 28 days of SCD-101, while others will receive the drug first, followed by the placebo. This method helps compare the two treatments using a relatively small sample size. To ensure accuracy, a 28-day “washout” period—when clinical trial participants are completely taken off a study treatment for a set amount of time—will follow each 28-day treatment period. This just guarantees that there will be no “carry-overs” or leftover effects of the first treatment into the second one.
This next phase of the trial will continue to test the safety and effectiveness of escalating doses of SCD-101—things like changes in sleep and exercise activity, pain incident and pain reliever usage, fatigue symptoms, and of course, sickling frequency. We expect to continue to see positive reactions from sickle cell warrior participants.
The best news, though? While FDA approval for the official drug development of SCD-101 may take another four years, you can purchase and use SCD-101 in its supplement form, Xickle RBC-Plus. With no known toxicity, Xickle helps prevent sickling in both children and adults. Why wait to get started?
For even more info on Xickle RBC-Plus/SCD-101, check out the video below:
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Clinical Trial Update: Our Product Has Been Recognized as an Effective Treatment for SCD
April 18, 2017 by AndreaCategory: Clinical Trials Tags: clinical trials, SCD-101, sickle cell treatment | Comments Off on Clinical Trial Update: Our Product Has Been Recognized as an Effective Treatment for SCD
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The Major Advancement in Sickle Cell Treatment That Has Everyone Talking
November 18, 2016 by Andrea
Photo: Public Domain
Over the past week, there have been some exciting developments toward the treatment of sickle cell. One has to do with Xickle's very own journey from supplement status to pharmaceutical drug status (more on this in the coming weeks). Another has to do with the developments in gene editing from scientists at Standford University School of Medicine.
At Stanford, those scientists have successfully used the gene-editing tool, CRISPR, on the very gene that causes sickle cell -- mending it in stem cells taken from sickle cell warriors. The study, which was published last week in Nature, discusses how Dr. Natthew Porteus and his team repaired the gene mutation in 30 to 50 percent of cells with SCD. Then, those cells were injected into mice, and according to Reuters, those same cells were still functioning properly 16 weeks later.
"What we've finally shown is that we can do it," said Porteus in ScienceDaily. "It's not just on the chalkboard. We can take stem cells from a patient and correct the mutation and show that those stem cells turn into red blood cells that no longer make sickled hemoglobin."
The next step? Human clinical trials. Right now, the plan is to begin those trials in 2018. This is definitely a historic advancement in the treatment of SCD, and we're excited to see where it leads.
For more information on the study and the process planned for human clinical trials, read the entire articles below:
1) ScienceDaily: "Step toward gene therapy for sickle cell disease"
2) Reuters: "Stanford uses CRISPR to correct sickle cell, human trials planned"
3) TheScientist: "More Success Fixing Sickle Cell Gene with CRISPR"Category: Clinical Trials, Sickle Cell Disease Tags: CRISPR, sickle cell awareness, sickle cell disease, sickle cell treatment | Comments Off on The Major Advancement in Sickle Cell Treatment That Has Everyone Talking
