SSI Clinical History

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Overview of SSI clinical use

Qu Biologics currently has more than five years clinical experience with the use of its SSIs in clinical trials and compassionate use programs. This experience comprises of placebo-controlled, randomized clinical trials and uncontrolled, unblinded observations of therapeutic practice. The compassionate use program represents preliminary data from which proof of benefit of SSIs cannot be established.

In total, more than 350 patients have received Qu Biologics’ SSIs. 68 patients received Qu Biologics SSIs through a placebo-controlled, randomized clinical trial, 10 patients through an open-label clinical trial and 272 patients received Qu Biologics’ SSIs through a compassionate use program.

The 350 patients who received Qu Biologics’ SSI treatment included 254 patients  with advanced cancer, 89 living with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and eight patients with other immune-related disease, all of whom were treated with one or more of Qu Biologics’ SSIs (i.e., QBECO, QBKPN, QBSAU, and/or QBECP), as summarized in the table below. 188 patients have received QBECO SSI, the investigational treatment under study in the Crohn’s disease and ulcerative colitis clinical trials. To learn more about the safety and efficacy of QBECO SSI for the treatment of inflammatory bowel disease, click here.

Distribution of patients treated with Qu Biologics’ SSIs to date

Indication

# of patients treated for cancer

# of patients treated for immune-related disease

Total # of patients treated

Cancer

254

0

254

Crohn’s disease (CD)

0

78*

78

Ulcerative colitis (UC)

0

13

13

Arthritis

0

5*

5

Other

0

2

2

TOTAL

254

98

352

*One (1) patient with Crohn’s disease was treated with QBECO and QBSAU for both g.i. symptoms and arthritis symptoms of Crohn’s disease, and thus appears in both the Crohn’s disease and arthritis patient statistics.

SSI Family of Treatments

SSIs and their potential clinical indications are described in the table below. The investigational use of SSIs began with the treatment of advanced cancer patients and more recently, Qu Biologics began evaluating the potential of SSIs for the treatment of immune-related diseases including inflammatory bowel disease and arthritis.
Qu Biologics’ Family of Investigational Site Specific Immunomodulators (SSIs)

SSI Name

Target organ

Potential Cancer indications

Potential Immune-related
disease indications

QBECO

Colon

Colorectal, ovarian, liver and pancreatic cancer

Crohn’s disease (CD),
Ulcerative colitis (UC)

QBKPN

Lung

Lung cancer

Chronic Obstructive Pulmonary Disease (COPD)1, asthma

QBSAU

Skin, breast & bone

Breast and bone cancer, melanoma

Rheumatoid arthritis

QBECP

Prostate & urinary tract

Prostate, kidney and bladder cancer

Interstitial cystitis1

1COPD and interstitial cystitis are both inflammatory conditions that are potentially of interest for SSI therapy, however, unlike the other diseases listed above, no clinical data is available to indicate that SSIs are of any value in treating these two conditions.

SSI Clinical Safety Profile

In both the placebo-controlled, randomized clinical trial and the preliminary, uncontrolled, unblinded compassionate use studies, SSI therapy was reported to be 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. As mentioned above, these studies were uncontrolled and unblinded, therefore these results cannot be interpreted as establishing the safety of Qu Biologics’ SSIs.  In drug development, large double-blinded placebo controlled studies are needed to provide full information on a drug’s more common side effects (adverse events).