Panbela Therapeutics Inc
said that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 ASPIRE trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients in the trial.
The DSMB has recommended that the study continue without modification.
The ASPIRE Trial is a global, randomized, double-blind, placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma.
"We are pleased that no safety concerns were identified, and the DSMB's recommendation is to proceed without modification to the ASPIRE Trial. With a focus on enrollment and completing site initiations, we are looking forward to the interim analysis in early 2024," said Jennifer Simpson, President & CEO.
HC Wainwright identifies potential expansion avenues for Ivospemin, including additional cancer types like ovarian, prostate, colon, breast, and lung.
Panbela has planned a Phase 1 clinical trial for the second quarter of 2023 to evaluate Ivospemin in treating platinum-resistant ovarian cancer.
Although the prospects for Ivospemin appear encouraging, the analyst acknowledges the inherent challenges in developing pancreatic cancer therapy, highlighting the limited success of recently developed drugs in improving overall survival.
The fact that Panbela possesses a pipeline that extends beyond PDAC provides some reassurance, according to the analyst, helping to mitigate risks and potentially offering value in treating other indications.
The analyst maintains a Buy rating and a price target of $16.
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