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http://www.qubiologics.com/studies/compassionate-human-use-program/ said...
Using SSIs to Treat Autoimmune Disease

With growing evidence that macrophage dysfunction may underlie a variety of autoimmune conditions, the compassionate use program was expanded to include patients with autoimmune disease. Eighteen patients with Crohn’s disease (N=10), ulcerative colitis (N=2), a non-autoimmune bowel condition (N=1), arthritis (N=5, note: one patient with Crohn’s disease-associated arthritis was treated for both the gastrointestinal and the arthritic symptoms of Crohn’s disease) and an inflammatory skin condition (N=1) were enrolled in the program. All patients had active disease that was uncontrolled by standard treatment at time of enrollment. SSI treatment was generally found to have an acceptable safety profile and be well-tolerated. Patients were treated with SSIs as follows:


Crohn’s Disease

Ten of ten patients had a therapeutic response to treatment, based on patient-reported improvement in symptoms. The majority of patients achieved therapeutic response within one to three weeks of starting treatment. Seven of the ten patients (70%) with Crohn’s disease had full resolution of clinical symptoms after completing a course of QBECO treatment of three months duration or more. Four of these patients have had sustained clinical remission after discontinuing all medications including SSI treatment. The longest clinical remission is ongoing, after more than 3 years. Three of ten patients (30%) have had follow-up colonoscopies or CT scan with confirmation of full remission. To learn more about our current clinical trial for Crohn’s disease, visit our Qu Crohn’s Trial website at www.qucrohnstrial.com.


Ulcerative Colitis

Both patients began to notice improvement in symptoms (i.e., reduced bowel movement frequency, reduced urgency, and reduction of blood in stool) two to three weeks after initiation of treatment. Both patients are in full clinical remission and have discontinued all other medications.


Arthritis

All five patients have had a therapeutic response to SSI. Patients noticed an initial reduction in morning stiffness after two to three weeks of treatment, with a subsequent reduction in joint pain and swelling. All patients have reduced their concomitant medications and have maintained benefit.



The clinical outcomes observed through the compassionate use experience in autoimmune diseases are preliminary and are not evidence of efficacy or safety at this stage of development. Further, the observations of clinical benefit described above cannot be attributed to the independent value of SSI therapy given the uncontrolled and unblinded nature of the compassionate use program. Based on these preliminary observations, Qu Biologics is planning methodologically-rigorous clinical trials to establish the independent contribution of SSI treatment to improved clinical outcomes for patients with autoimmune diseases.