Respiratorius presents positive results from clinical studies of VAL001
Respiratorius reports positive results from clinical phase I/IIa studies of VAL001.
The key results from the Phase I / IIa studies are presented briefly:
- • Published scientific results from the Phase I study show a potential synergistic effect with Rituximab as VAL001 increases the levels of the surface protein CD20.
- • Overall Survival Analysis for 32 patients treated with VAL001 and R-CHOP shows that 1-year survival is 100% and 2-year survival is 96.8%. Comparative data from a matched reference population of 330 patients from The Swedish lymphoma registry treated with R-CHOP alone provides 1-year survival of 89.6% and 2-year survival of 81.7%. This shows a statistically assured survival benefit (p = 0.034) for patients treated with VAL001 and R-CHOP compared to those treated between 2000–2015 with R-CHOP alone.
- • Survival data thus shows a further improvement compared with previously presented interim analysis, which is very pleasing.
The assessment is that the clinical studies have been successful, especially overall survival in patients treated with VAL001 compared with a reference group. The main example (see Table 1) is that despite the limited patient base, 2-year survival at 95% confidence interval is significantly higher for patients treated with VAL001, compared to the reference population.
In this context, it should be noted that the study is not a randomized study, i.e. no comparison with placebo has been performed. For 1-year survival, comparison with confidence intervals is not possible because everyone survived in the group treated with VAL001.
Kristina Drott, Member of the Board of Respiratorius and inventor of VAL001, said in a comment: "The results of the clinical study are good, and I am still positive for major comparative studies."
VAL001 is a patented, with patents granted in Europe and Japan, combination of approved and well tolerated drugs, and is given as pre-treatment for cytostatics treatment (R-CHOP) in the treatment of diffuse large cell B cell lymphoma (DLBCL), the most common type of non-Hodgkin's lymphoma which annually affects about 60,000 people in the US and Europe. The 5-year survival rate for the disease is approximately 65-70%.
Phase I/IIa studies have been conducted at Skåne's oncology clinic, SUS in Lund / Malmö, Akademiska sjukhuset in Uppsala and at Cancer Center, Norrlands University Hospital in Umeå. VAL001 is given as pre-treatment for standard chemotherapy, with the addition of Rituximab (R-CHOP), in the treatment of diffuse large cell B-lymphoma.
Previously, it has been announced that results from the study would be published in Q2 2018, but the assessment is that the patient who has not yet completed the final follow-up, 24 months after completion of treatment, will not significantly affect the final result. The patient is expected to be cured just over 20 months after completion of treatment.
Table 1 Overall Survival
|Confidence Interval [%]|
|VAL001 + R-CHOP (Study)||Survival [%]||95% Low||95% High|
|R-CHOP (Reference Group)|
This information is information that Respiratorius AB (Publ) is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact person for publication on February 28, 2018.
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