Lund-based drug developer Respiratorius continues to advance the project with drug candidate VAL001. The company recently announced positive preclinical results that showed that VAL001 may have potential even for patients with a more severe type of diffuse large B-cell lymphoma. Now there are signs that the candidate could potentially also be used in the treatment of patients who relapse into disease.
Respiratorius is developing the drug candidate VAL001, which is intended to help patients being treated for diffuse large B cell lymphoma (DLBCL). DLBCL is a rare and aggressive form of lymph node cancer where the standard treatment today consists of so-called R-CHOP, a combination treatment consisting of chemotherapy in combination with immunotherapy.
VAL001 is intended to be used in combination with R-CHOP and the results from the completed phase II/IIa study were so promising that the European Medicines Agency EMA recommended Respiratorius to go directly to phase III with the development project, which means that the company does not need to conduct a cost-intensive phase IIb study.
You can read more about the candidate here.
Increasing the value of the project
Since the project is soon ready for phase III, several activities are underway to increase value in preparation for a partnership deal, with the development of a new formulation being the most important. Preliminary results from the ongoing pharmacokinetic study conducted in Finland showed that the relatively high doses of VAL001 required for efficacy are safe, and that the expected concentrations are achieved. The study is expected to last into the second quarter of the broken fiscal year.
The company has also conducted several preclinical studies to document the potential efficacy of VAL001 in other related therapy areas. Among other things, the efficacy of valproate has been studied in combination with R-CHOEP, an intensified chemotherapy treatment given to patients with DLBCL who are under 70 years of age with medium or high disease risk.
Potential effect even in inpatients who are in the tingling
Results from another preclinical study have now also shown that VAL001 may be used in the treatment of patients who relapse into DLBCL after first completing treatment with R-CHOP or R-CHOEP. In a test tube study, valproate improved the inhibitory effect on cell growth in combination with bendamustine, gemcitabine or carboplatin, all of which are cytotoxic substances currently used in the treatment of these patients. A patent application for the new use of VAL001 has been filed.
BioStock contacted Respiratorius CEO Johan Drott to find out more about what the new results mean for the company.
Johan, you now get further evidence of an expanded potential for VAL001. What does this mean for the project?
– The results confirm that VAL001 also has efficacy together with drugs used in the secondary treatment of DLBCL patients who relapse into disease. This emphasizes the potential that the candidate has as a treatment of DLBCL. However, these results need to be verified in clinical studies and may add relapsing DLBCL as an additional indication for VAL001. This would of course have been attractive in the partnering process that is underway for VAL001, but it is nothing that we plan to investigate further in-house. This work will have to be done by a possible partner.
How do you view the results in relation to the partnering process that is underway?
– We will intensify the work on the partnering process, and, with the help of the new results, we believe that we have further developed the offer by being able to offer the treatment to a broader group of patients. Thus, the basis for a phase III study can also be expanded, which may facilitate marketing approval.
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