Stem cell ther­a­pies for space mis­sions? Pluris­tem joins forces with NASA to com­bat space-re­lat­ed ail­ments

When in space, your in­ner ma­chin­ery can go awry — ask as­tro­naut Scott Kel­ly. The as­sault of pro­tract­ed ra­di­a­tion and mi­cro­grav­i­ty can cul­mi­nate in pro­gres­sive bone and mus­cle loss and vex the im­mune sys­tem. Pla­cen­ta-based stem cells may be the an­swer to lim­it­ing that dam­age, and Is­rael’s Pluris­tem is work­ing with NASA to de­vel­op such an an­ti­dote.

The com­pa­ny, which is al­so work­ing with the NIH and the US De­part­ment of De­fense, last year se­cured the FDA’s emer­gency use au­tho­riza­tion for its stem cell prod­uct for ra­di­a­tion poi­son­ing. It al­so has two late-stage pro­grams test­ing the po­ten­tial of its ex­per­i­men­tal stem cell ther­a­pies for use in crit­i­cal limb is­chemia and mus­cle in­jury fol­low­ing sur­gi­cal re­pair. The com­pa­ny’s off-the-shelf prod­uct is de­rived from pla­cen­ta fol­low­ing full term de­liv­ery, and the cells can be ad­min­is­tered to pa­tients with­out the need for tis­sue match­ing.

“Once the cells are in­ject­ed, they se­crete a va­ri­ety of pro­teins and cy­tokines that help the body re­gen­er­ate, em­pow­er­ing the body’s heal­ing abil­i­ty,” Pluris­tem’s co-chief Yaky Yanay told End­points News.

The NASA tie-up came about af­ter Ruth Globus, of NASA’s Ames Re­search Cen­ter in Sil­i­con Val­ley, was giv­en the 2019 NASA Ames Re­search In­no­va­tion Award on the ba­sis of her pro­posed col­lab­o­ra­tion with Pluris­tem.

“Un­less as­tro­nauts al­lo­cate about two hours of time for dai­ly ex­er­cise ses­sions…As­tro­nauts can ex­pe­ri­ence up to 20% mus­cle loss in mus­cle mass on space flights last­ing just five to eleven days and in longer mis­sions, they al­so lose bone den­si­ty at a rate of 1-2% per month which can lead to more frag­ile bones,” Globus said in a state­ment on Wednes­day.

Last week, it was re­port­ed that near­ly a year in space put as­tro­naut Scott Kel­ly’s im­mune sys­tem in hy­per­drive. Typ­i­cal­ly as­tro­nauts are in space about six months at a time, but Kel­ly set a US record af­ter spend­ing 340 days in the skies.

Through Pluris­tem’s work with the NIH and DoD, the com­pa­ny was in­tro­duced to NASA and showed the space agency its da­ta from its mus­cle re­gen­er­a­tion stud­ies. Now with the NASA part­ner­ship in place, the drug de­vel­op­er is gear­ing up for pre­clin­i­cal and in vit­ro stud­ies to test the po­ten­tial of its pla­cen­tal stem cells in pre­vent­ing and treat­ing med­ical con­di­tions caused dur­ing space mis­sions, in­clud­ing in­di­ca­tions re­lat­ing to blood, bone, mus­cle, brain and heart.

Da­ta are ex­pect­ed lat­er this year, and if pos­i­tive, Pluris­tem will work with the FDA to de­ter­mine how to con­duct in-hu­man stud­ies.

“If we are able to demon­strate it in space, which is an ac­cel­er­a­tor (of ag­ing), its some­thing we can use in earth as well, to sup­port well be­ing, ag­ing and qual­i­ty of life,” Yanay said. “Cell ther­a­py on one hand, and space mis­sion on the oth­er end — on­ly good things can come from that!”


Yaky Yanay. PLURIS­TEM via TWIT­TER

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.

Arde­lyx bags its first FDA OK for IBS, set­ting up a show­down with Al­ler­gan, Iron­wood

In the first of what it hopes will be a couple of major regulatory milestones for its new drug, Ardelyx has bagged an FDA approval to market Ibsrela (tenapanor) for irritable bowel syndrome.

The drug’s first application will be for IBS with constipation (IBS-C), inhibiting sodium-hydrogen exchanger NHE3 in the GI tract in such a way as to increase bowel movements and decrease abdominal pain. This comes on the heels of two successful Phase III trials.

Ver­tex deal for Scot­land — no deal for Eng­land

Cystic fibrosis (CF) drug maker Vertex Pharmaceuticals — which is still locked in negotiation with NHS England to endorse the use of its medicines — has successfully negotiated a deal with Scottish authorities.

A month ago, the Scottish Medicines Consortium spurned two of the company’s medicines — Orkambi and Symkevi — citing uncertainty over their long-term efficacy in relation to their cost.

Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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