Pendrea’s clinical approach of targeting restoration of efficacy for standard of care chemotherapeutics in relapsed & refractory patients is designed to allow rapid progress toward the demonstration of efficacy in Phase 2 testing. The Company’s up-coming Phase 2 trial is designed to produce efficacy results sufficient to support an application for FDA approval to progress to Phase 3 and in the relatively short timeframe of only 2 years.
Pendrea’s product pipeline is shown in the chart below.
Pipeline Chart Notes:
Ceraxa #1 and Ceraxa #2 are Solid Tumor Products are for Pancreatic, Liver, and/or Hormone Resistant Prostate Cancer. Each is being tested in Phase 2.
AML is Acute Myeloid Leukemia
Ceraxa #1 and Ceraxa #2 are Ceraxa co-administered with a Standard of Care therapeutic
Ceraxa Plus products are 2nd generation products that encapsulate a Standard of Care therapeutic within Ceraxa
PINT is Photo Immuno Nano Therapy (ICG encapsulated in a NanoJacket)
mRNA Therapy is mRNA encapsulated in a NanoJacket
The Company’s underlying technology offers the opportunity to develop a large number of products, while the use of three different technology platforms mitigates the potential risk due to failure of any one product or technology.
The breadth of the product platform provides for the early stage development of numerous product and product types. Pendrea intends to carry selected product candidates through Phase 2 (efficacy testing) prior to partnering. The Company views the balance of the products in early stage development as potential partnering opportunities that provide a substantial upside for Pendrea in terms of building value and revenue.
It is interesting to note that Pendrea sees distinct parallels between its development of Ceraxa and Bristol-Myers Squibb’s development of Taxol. Despite its known anti-cancer potential, Taxol was nearly impossible to use as a pharmacological agent due to its extremely low solubility. However, once Bristol Myers solved the solubility problem, Taxol became a major billion dollar cancer drug. Pendrea, by unlocking the potential of ceramide through its proprietary formulation, believes Ceraxa will emulate Taxol’s importance and growth as a cancer drug.