Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2487

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2487
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 in patients suffering from brain cancers, and we anticipate many of
our patients will likely already have one in place.

We
intend to model our Phase 1/2 clinical trial after the Phase 1/2 clinical trial of Johnson and Johnson’s Zarnestra sponsored by
M.D. Anderson Cancer Center (NCT00050986). The envisioned clinical trial plan involves a dose escalation SAD/multiple ascending dose,
or MAD, strategy followed by continued assessments of safety parameters and efficacy using six-month progression free survival as the
primary endpoint. We anticipate also monitoring tumor size during this trial using radiology techniques in the interest of acquiring
efficacy data more rapidly than the primary endpoint is likely to provide.

Our
Phase 3 clinical trial for OCX-909 is tentatively planned to follow the example of Merck’s CENTRIC trial of Cilengitide (NCT00689221).
The CENTRIC trial used overall survival as the approval endpoint leading to a study duration over five years. We intend to continue to
work with the oncology community to develop novel validated biomarkers, which could allow for accelerated trials in GBM. We are optimistic
that these novel tools may allow for accelerated trials in the GBM space which could speed the transition of OCX-909 to the market. We
intend to seek orphan drug designation for OCX-909 in GBM and may also request priority review.

Fibrosis
Product Candidate for IPF and HPS:

    ●
    OCF-203
    anti-Chit1 Small Molecule

Overview
of Fibrotic Diseases

An
important protective mechanism for tissue regeneration and wound healing is the formation of extracellular matrix, or ECM, a non-cellular
portion of a tissue produced and secreted by cells and functions mainly to provide support for tissues.

Fibrosis
is a pathologic condition where an excessive accumulation of ECM leads to organ disfunction and failure. Fibrotic diseases constitute
a major health problem worldwide and encompass a wide spectrum of clinical entities including systemic fibrotic diseases such as systemic
sclerosis, or SSc, scleroderma and nephrogenic systemic fibrosis, as well as numerous organ-specific disorders including pulmonary, cardiac,
liver and kidney fibrosis.

24

The
United States government estimates that 45% of deaths in the United States can be attributed to fibrotic disorders. Fibrosis is a factor
in various tissue and organ diseases as shown in the figure below.