Immuron Ltd — Regulatory Filings 2011

Apr 18, 2011

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Immuron and US FDA to meet in relation to phase 2b tria Company granted pre-IND meeting to set clinical program

Melbourne, Australia, 19 April 2011: Immuron L imited (AS X : IMC), a b iopharma c eutical and drug developm e nt company has been granted a pre-IND (in v estigation a l new dru g ) meeting with the U S Food a n d Drug Ad m inistration as it progr e sses a landmark pha s e 2b clinical trial program for its lead drug candi d ate IMM 1 2 4E to trea t non-alcoholic steato h epatitis (N A SH).

“The pre - IND proce s s is desig n ed to assis t sponsor companies to progress with clinic a l trials that mee t FDA requ i rements,” s tated Imm u ron chief e xecutive officer Mr Jo e Baini.

“We wel c ome this o p portunity t o meet wit h the FDA a s it will hel p our phas e 2b clinical trial program progress a s seamlessly as we c a n manage. The pre-IND process s hould assist in the design o f our propo s ed trial an d decrease the possibility of futur e delays in t he develo p ment of IMM 124 E in the tre a tment of N ASH.”

Non- alc o holic steat o hepatis, or fatty liver d isease, is a condition that is bec o ming incr e asingly prevalen t in develo p ed nations and is link e d to increases in obe s ity rates a n d type 2 di a betes prevalen c e. It is estimated that twenty five million Am e ricans will have NAS H by 2025. If left untreate d , NASH can lead to life threateni n g disease s such as c i rrhosis an d liver failur e . IMM 124E is a n orally ad m inistered d rug candi d ate developed from h y per-immu n e bovine colostrum. Phase 1/2 clinical trials of IMM 124E dem o nstrated it s potential a gainst NA S H, as me a sured by liver enz y me marke r s and type 2 diabetes markers. E arly results also show e d IMM 12 4 E was well tolerated and a b le to decr e ase blood t riglyceride levels and improve ke y metaboli c hormone s linked to c hronic infl a mmation.

Contact Joe Bain i – Chief E x ecutive Officer Emma P o wer +61 3 86 3 7 1107 Mon s oon Com m unications joe@im m uron.com (03) 9 620 3333 0419 149 525

About Immuron Limited

Immuron is a bioph a rmaceutic a l company focused o n oral immunotherapy u sing dairy - derived antibody products f o r humans. Immuron i s a uniquely positioned biotechnol o gy compa n y with a versatile technology platform c a pable of g e nerating a wide rang e of produc t s with a hi g h safety profile. T his high s a fety profile makes it p o ssible to c o mplete pr e -clinical st u dies relati v ely quickly a n d increas e s the pros p ect that th e clinical d e velopment of Immuro n ’s product s will be expedite d . Immuro n ’s current p roducts a n d product c andidates t arget infec t ious disea s es of the gastroint e stinal trac t , chronic diseases su c h as fatty liver (NASH ) , and the p revention o f influenza. Immuron has one p r oduct in th e market, Travelan, fo r preventin g travellers’ diarrhoe a . Immuron’s main sci e ntific allia n ces are with Hadassa h Medical C enter (Isra e l) and the Universit i es of Melb o urne and M onash (A u stralia).