Taxus Cardium Pharmaceuticals Group Inc (CRXM)

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Generx® (alferminogene tadenovec, Ad5FGF-4)
Sponsor(s): Angionetics, Huapont Life Sciences (exclusive territorial distribution and license agreement for China)
Indication(s): Refractory angina (Phase III); Cardiac syndrome X (Phase I/II); Congestive heart failure (Phase I/II); Moyamoya disease (IND-enabling), Cerebral ischemia (Candidate selection)
Mechanism: Generx consists of the human fibroblast growth factor-4 (FGF-4) gene, a CMV promoter sequence, and a signal peptide, encapsulated in a human serotype 5 adenovirus. Generx is delivered to the heart using Angionetic’s optimized cardiac catheter technique, binds to heart cells via the coxsackie adenovirus receptors, and transfects the cells with the FGF-4 gene.
Trial(s) (Identifier): NCT02928094 (AFFIRM, Phase III)
Updates: NCT02928094 is expected to start June 1, 2019, with an estimated primary completion date of June 1, 2021. Angionetics is a majority-owned subsidiary of Gene Biotherapeutics (formerly Taxus Cardium Pharmaceuticals Group), but operates independently. Last year, Angionetics said it plans to externally finance clinical development and commercialization of Generx, which could include an initial public offering in 2019.