Paloma Pharmaceuticals receives FDA approval to enter Phase I studies with P529

Paloma Pharmaceuticals, Inc. announced today that it has received acceptance of its IND to enter Phase I studies with Palomid 529 (P529) in patients with age-related macular degeneration (AMD).  The Phase I study, "A Phase I Open-Label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single Intravitreal and Subconjunctival Doses of Palomid 529 in Patients with Advanced Neovascular Age-Related Macular Degeneration" will be a dose-ranging study aimed at safety but will also have objective measurement for efficacy.

P529 is a non-steroidal, synthetic, small molecule drug created through computational design, synthetic and medicinal chemistry, the result of three generations of Palomid design work.  P529's broad activity resides in its ability to target and inhibit the PI3K/Akt/mTOR signal transduction pathway as a dual TORC1/TORC2 inhibitor.  It is a first-in-class PI3K/Akt/mTOR inhibitor causing the dissociation of both the TORC1 and TORC2 complexes.

"As P529 is an inhibitor of both the TORC1 and TORC2 arms ultimately controlling the PI3K/Akt/mTOR pathway it would be expected to have broad activity as an anti-angiogenic agent and further inhibit vascular permeability, two aspects that make a compelling story for clinical studies in AMD.  We look forward to working with Paloma Pharmaceuticals on this interesting approach to wet AMD," said Dr. Jeffrey Heier, M.D., principal investigator of the study with Ophthalmic Consultants of Boston.

"We are pleased to have the FDA accept our IND package for initiation of Phase I human studies.  This external validation of P529 as a therapeutic agent to combat eye disease gives credence to not just our program for ocular disease but as P529 will be used formulated for other therapeutic areas, it also leads the way for acceptance of up-coming Phase I studies in cancer, epilepsy, dermatologic diseases and other indication areas in our pipeline," said Dr. David Sherris, Ph.D., President and CEO of Paloma Pharmaceuticals.

SOURCE Paloma Pharmaceuticals, Inc.

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