AIM ImmunoTech presented data from its Ampligen clinical program for pancreatic cancer at the International 5th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care in Poland. The data showed promise in Progression-Free Survival and Overall Survival in both the DURIPANC clinical trial and an Early Access Program. The Company's drug Ampligen has patent protection and orphan drug designations for the treatment of late-stage metastatic pancreatic cancer.
AIM ImmunoTech Inc. (NYSE American: AIM) presented encouraging data from its Ampligen clinical program for pancreatic cancer at the International 5th Annual Marie Skłodowska-Curie Symposium on Cancer Research and Care in Poland. The company highlighted positive results from both the Phase 2 DURIPANC clinical trial and an Early Access Program, focusing on Progression-Free Survival (PFS) and Overall Survival (OS) metrics [1].
The DURIPANC study, currently underway at Erasmus University Medical Center in the Netherlands, evaluates Ampligen in combination with AstraZeneca's durvalumab for treating late-stage metastatic pancreatic cancer. The company has secured patent protection for this combination through 2039 and holds both US and EU orphan drug designations for market protection upon approval [1].
The orphan drug designations are significant regulatory advantages, providing market exclusivity (7 years US/10 years EU) and potentially expedited review pathways. For a small biotech like AIM, these designations substantially enhance the commercial viability of their candidate [1].
Pancreatic cancer's dismal survival rates and limited treatment options make any promising data in this field potentially transformative. However, investors should note that this remains a Phase 2 trial, requiring larger Phase 3 studies before potential approval. The lack of specific efficacy numbers in this release also warrants caution when assessing clinical significance versus statistical significance [1].
AIM ImmunoTech's CEO, Thomas K. Equels, stated, "Ampligen continues to demonstrate its potential for the treatment of late-stage metastatic and locally advanced pancreatic cancer. Our growing body of positive data continues to bolster our confidence. This lethal malignancy is a high unmet need. In particular, the Progression-Free Survival and Overall Survival – which are the gold standards for drug approval – seen in the clinical data demonstrated to date underscore our strong belief in the potential" [1].
For more information on Ampligen and to stay up to date with the latest advancements, please visit AIM ImmunoTech's website [1].
References:
[1] https://www.stocktitan.net/news/AIM/aim-immuno-tech-highlights-growing-body-of-compelling-data-of-cvnp2oxlui1l.html
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