Pfiz­er and Astel­las are gun­ning to add a fourth in­di­ca­tion to their can­cer drug Xtan­di with Phase III tri­al re­sults re­leased to­day.

The study, look­ing at Xtan­di plus le­upro­lide and Xtan­di as a monother­a­py in men with non-metasta­t­ic hor­mone-sen­si­tive prostate can­cer, met its pri­ma­ry end­point with a “sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful im­prove­ment” in metas­ta­sis-free sur­vival in the pa­tients treat­ed with Xtan­di plus le­upro­lide, ac­cord­ing to the com­pa­nies, though no de­tailed da­ta was giv­en.

Xtan­di is al­ready ap­proved in the US in men as a dai­ly ther­a­py with metasta­t­ic hor­mone-sen­si­tive prostate can­cer, metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer and non-metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer.

Le­upro­lide is an al­ready-ap­proved drug com­mon­ly used to treat symp­toms of ad­vanced prostate can­cer, of­ten un­der the brand names Eli­gard and Lupron. It works by low­er­ing the amount of testos­terone, which can help slow the growth of can­cer cells. Lupron was first ap­proved for use in prostate can­cer in 1985.

“While cur­rent treat­ment op­tions for lo­cal­ized prostate can­cer are in­tend­ed to be cu­ra­tive, some men re­main at high­er risk for bio­chem­i­cal re­cur­rence fol­low­ing pri­ma­ry treat­ment, which may re­sult in metas­tases,” Ah­san Arozul­lah, se­nior VP and head of de­vel­op­ment in ther­a­peu­tics at Astel­las, said in a state­ment.

“The EM­BARK tri­al is the first study to demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in MFS us­ing the com­bi­na­tion of XTAN­DI plus le­upro­lide in men with this stage of dis­ease.”

The sec­ondary end­point, over­all sur­vival, showed a “pos­i­tive trend” but the da­ta aren’t ma­ture, ac­cord­ing to the com­pa­nies. There will be a fi­nal analy­sis of the da­ta af­ter fol­low­ing up with the pa­tients.

An­oth­er sec­ondary end­point look­ing at Xtan­di as a monother­a­py al­so showed “sta­tis­ti­cal­ly sig­nif­i­cant” im­prove­ment in metas­ta­sis-free sur­vival.

Ac­cord­ing to the press re­lease, the com­pa­nies will dis­cuss the da­ta with the FDA about a po­ten­tial new sub­mis­sion for Xtan­di in this can­cer.

Xtan­di was first ap­proved back in 2012 for late-stage cas­tra­tion-re­sis­tant prostate can­cer, and since then, more than 720,000 pa­tients have been treat­ed with XTAN­DI glob­al­ly, ac­cord­ing to da­ta from Astel­las.

But the price has been a grow­ing con­cern — in Jan­u­ary, de­mo­c­ra­t­ic law­mak­ers added their voic­es to the mix and pressed for the fed­er­al gov­ern­ment to use its march-in rights to low­er the price of Xtan­di.

The law­mak­ers re­quest­ed a pub­lic hear­ing on a pe­ti­tion to low­er Xtan­di’s price filed by pa­tients by al­low­ing gener­ic drug­mak­ers to pro­duce cheap­er ver­sions of the drug, over­rid­ing the patent mo­nop­oly. The av­er­age whole­sale price is more than $189,000 per year, the pe­ti­tion­ers wrote to HHS Sec­re­tary Xavier Be­cer­ra.

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.