Di­al­ing down the tox­ic ef­fects of ra­di­a­tion on can­cer pa­tients, Galera gets break­through sta­tus on Phase IIb da­ta

A biotech­nol­o­gy com­pa­ny near Philadel­phia — armed with da­ta from a Phase IIb tri­al — just got break­through sta­tus from the FDA for a drug that might re­duce the harm­ful ef­fects of ra­di­a­tion ther­a­py for can­cer pa­tients.

The com­pa­ny, Galera Ther­a­peu­tics, has an in­tra­venous drug (meant to be tak­en right be­fore ra­di­a­tion treat­ment) that might mit­i­gate the tox­ic ef­fects. Es­sen­tial­ly, when pa­tients un­der­go ra­di­a­tion, their bod­ies are over­whelmed by a com­pound called su­per­ox­ide, which is de­ployed by the im­mune sys­tem to kill in­vaders. Nor­mal­ly, the body can break down su­per­ox­ide, con­vert­ing it to hy­dro­gen per­ox­ide and mol­e­c­u­lar oxy­gen. But when un­der­go­ing in­tense ra­di­a­tion, the body can’t keep up.

Mel Sorensen

“Our drug mim­ics the ef­fect of that nat­ur­al en­zyme, and does it po­tent­ly,” Galera’s pres­i­dent and CEO Mel Sorensen tells me.

First, Galera is tack­ling a se­vere side ef­fect of ra­di­a­tion that af­flicts head and neck can­cer pa­tients. These pa­tients of­ten de­vel­op a con­di­tion called se­vere oral mu­cosi­tis, or SOM, which hap­pens when sen­si­tive tis­sue in the mouth is sub­ject­ed to ex­ces­sive su­per­ox­ide gen­er­at­ed dur­ing ra­di­a­tion treat­ment. This breaks down the ep­ithe­lial cells that line the mouth, caus­ing pa­tients to suf­fer from se­vere pain, ul­cer­a­tions, and bleed­ing of the mouth. It’s of­ten so bad that the pa­tient can’t eat or drink.

“The prob­lem isn’t just the im­me­di­ate ef­fect of the pain, sore­ness, and lack of nu­tri­tion, but al­so the resid­ual ef­fects,” Sorensen said. “It can cause dry mouth for years af­ter treat­ment.”

In pa­tients with head and neck can­cer, ra­di­a­tion is a main­stay, and about 70 per­cent of pa­tients re­ceiv­ing this treat­ment de­vel­op SOM.

The FDA has grant­ed break­through ther­a­py des­ig­na­tion for Galera’s drug, coined GC4419, based on the da­ta from a 223-pa­tient, dou­ble-blind, ran­dom­ized, place­bo-con­trolled Phase IIb clin­i­cal tri­al in pa­tients with head and neck can­cer. In the tri­al, GC4419 re­duced the du­ra­tion of SOM from 19 days to 1.5 days (92%), the in­ci­dence of SOM by 34%, and the sever­i­ty of pa­tients’ oral mu­cosi­tis by 47%.

Al­though start­ing with SOM, Sorensen said Galera’s drug might have ap­pli­ca­tions in many dif­fer­ent can­cers. Hy­dro­gen per­ox­ide, the byprod­uct Galera’s drug cre­ates when break­ing down su­per­ox­ide, hap­pens to be tox­ic to tu­mor tis­sue, Sorensen said. The com­pa­ny is hope­ful that ad­min­is­ter­ing the drug in com­bi­na­tion with high-dose ra­di­a­tion might pro­tect nor­mal tis­sue while fight­ing tu­mors.

“If we can do both of those, we’ve ef­fec­tive­ly trans­formed ra­di­a­tion ther­a­py,” Sorensen said.

The com­pa­ny is now re­cruit­ing for a Phase I/II tri­al test­ing GC4419 against pan­cre­at­ic can­cer.

Since the com­pa­ny’s found­ing in 2009, it’s raised $77 mil­lion ($20 mil­lion Se­ries A, $57 mil­lion Se­ries B). Sorensen wouldn’t say how much run­way the com­pa­ny has or whether it would need to raise more mon­ey be­fore tak­ing GC4419 in­to Phase III tri­als. He did note, how­ev­er, that the com­pa­ny has a strong in­vestor syn­di­cate in­clud­ing No­var­tis Ven­ture Fund, New En­ter­prise As­so­ci­ates, Sofinno­va, and oth­ers.

“We’re look­ing at all ways to op­ti­mize the fi­nan­cial side of this,” Sorensen said. “We’re still think­ing about what’s the best way to fi­nance the Phase III, and we’re talk­ing with lots of peo­ple.”

Im­age: Can­cer cells. Shut­ter­stock

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