SSI Efficacy and Safety

“SSIs are not designed for incremental improvements to the ‘standard of treatment’ – they are designed to re-invent, complement and replace the standard.”

~ Dr. Simon Sutcliffe, Chief Medical Officer, Qu Biologics

Qu scientists crop wide

Since Qu’s inception in 2007, we have initiated a wide range of preclinical and clinical research programs to demonstrate and assess the efficacy and safety of SSI treatment. We have completed three Phase 2 clinical trials in Crohn’s disease, ulcerative colitis and non-small cell lung cancer, respectively.

Clinical data from Health Canada-approved Phase 2 clinical trials
  • For a summary of the results from the Health Canada-approved trial in Crohn’s disease, click here.
  • For a summary of the results from the Health Canada-approved trial in ulcerative colitis, click here.
  • For a summary of the results from the Health Canada-approved trial in lung cancer, click here.

 

Clinical data from compassionate use program provide precedent for current studies

From 2008 – 2013, prior to the initiation of our Health Canada-approved clinical trials, 272 patients received Qu Biologics’ SSIs through a compassionate use program, enrolling 254 patients with advanced cancer and 18 patients with other immune-related diseases, including Crohn’s disease, ulcerative colitis and autoimmune arthritis. A summary of the results is presented in the table below.

Compassionate Use Program

 

SSIs for the treatment of immune-related diseases

Ten patients with moderate to severe Crohn’s disease, two patients with moderate to severe ulcerative colitis, five patients with autoimmune arthritis and two patients with immune-related chronic inflammatory conditions were treated with Qu Biologics’ SSIs. All patients had active disease that was uncontrolled by standard treatment at time of enrollment. SSI treatment was reported to have an excellent safety profile and was well-tolerated; there were no treatment related serious adverse events reported and no allergic reactions were observed. Response associated with SSI treatment was, as follows:

Crohn’s disease
  • Ten of ten patients reported improvement in clinical symptoms.
  • The majority of patients reported clinical improvement within one to three weeks of starting treatment.
  • Eight patients were able to discontinue all other medications at some point while on QBECO SSI treatment.
  • Seven patients (70%) had full resolution of clinical symptoms with a course of QBECO SSI treatment of 2.5 months duration or more.
  • Three patients (30%) are in ongoing sustained clinical remission after discontinuing all medications including SSI treatment.
  • The longest remission is ongoing, since July 2010 (discontinued all medications, including SSI treatment since July 2011).
  • All three patients in ongoing sustained remission have had follow-up colonoscopies or imaging confirming remission.
Ulcerative colitis
  • Both patients went into sustained clinical remission during SSI treatment
  • Both patients were able to discontinue all medications, including SSI treatment
  • Both patients are in ongoing sustained remission, off all medications (more than 4 years after starting SSI treatment)
Arthritis
  • All five patients had a therapeutic response to SSI.
  • Four of five patients reported substantial improvement.
  • All five patients reduced their concomitant medications.
  • The majority of patients noticed reduction in morning stiffness within two to three weeks of starting treatment, with a subsequent reduction in joint pain and swelling.

 

Advanced cancer

254 patients with advanced cancer (including cancer of the breast, prostate, lung, colon, liver, skin, bone, and ovary) were treated with one or more of Qu Biologics’ SSIs for up to 3.5 years. SSI treatment was reported to have an excellent safety profile and was well-tolerated; there were no treatment related serious adverse events reported and no allergic reactions were observed.Please note: this compassionate use program is now closed.

Breast cancer

An independent research group initiated a retrospective analysis of patients treated with SSI in the late-stage cancer compassionate use program, comparing survival of patients with metastatic breast cancer (the largest patient group in the clinic) treated with SSI to metastatic breast cancer patients at the same clinic not treated with SSI. The analysis found that patients treated with SSIs had a 20 month longer median survival than those not treated with SSIs.

Late-stage cancer, all types combined

Encouraged by this promising initial clinical data, these researchers initiated a case-matched study in all late-stage cancer patients at the clinic, comparing survival of 43 patients with advanced cancer treated with SSIs to 43 matched patients treated at the same clinic with the same type/stage of advanced cancer who did not receive SSI. This case matched analysis found that patients treated with SSI had a median survival 12 months longer than those patients not treated with SSI.

Lung cancer

From 2008 to 2012, 105 patients with late stage primary lung cancer (40 patients) or lung metastases (65 patients) were treated with Qu Biologics’ QBKPN SSI in a compassionate use program.

An independent research group initiated a case-matched study of late-stage cancer patients as a preliminary assessment of SSI efficacy, comparing survival of patients treated with SSI to survival of matched patients at the same clinic with the same type/stage of cancer not treated with SSIs. The median survival of advanced cancer patients treated with SSIs was 12 months longer than the median survival of matched patients not treated with SSIs. In patients with advanced lung cancer, SSI treated patients had a median survival advantage of 15 months compared to their matched cases not treated with SSI.

These compassionate use experiences comprise uncontrolled, unblinded observations in clinical practice. Accordingly it represents preliminary data from which proof of benefit of SSIs cannot be established, but it does provide a precedent for formal clinical trials. Qu Biologics has completed a Health Canada-approved Phase 2 clinical trial in recurrent lung cancer. A summary of the results can be found here.

SSI Clinical Safety Profile

To date, more than 300 patients have been treated with SSIs in our compassionate use program and Phase 2 clinical trials.

  • For a summary of the results from the Health Canada-approved trial in Crohn’s disease, click here.
  • For a summary of the results from the Health Canada-approved trial in ulcerative colitis, click here.
  • For a summary of the results from the Health Canada-approved trial in lung cancer, click here.

 

In Qu Biologics’ compassionate use program, 272 patients with advanced cancer, Crohn’s disease, ulcerative colitis, autoimmune arthritis and other immune-related diseases were treated with SSIs. SSI treatment was well-tolerated with no treatment-related serious adverse events reported and no systemic allergic reactions observed. A small number of patients reported larger than anticipated transient injection site reactions (including one or more of the following symptoms: increased redness, tenderness, induration), or transient mild flu-like symptoms (including one or more of the following symptoms: muscle aches, fatigue) or transient fever. All of these symptoms were reported to resolve within a few days without requirement for treatment.

The compassionate use program was uncontrolled and unblinded and in a limited number of patients (n=272), therefore these results cannot be interpreted as establishing the definitive safety of Qu Biologics’ SSIs.

 

Past events:


Past events: