Lunch!

Iced tea, ice water, some kind of chicken thing with mushroom sauce.  Salad with uber tangy dressing, cheesecake . . .

At 1 pm Sue Maus gets on the stage in her powerchair to say thanks and introduce the advocacy speakers.  The first one is Donna Sullivan, (known to CC users as IMHopeful).  She’s a complete star.  Talking about how Chris Reeve’s appearance on Larry King LIve was her first introduction to sci . . . like so many people, she was shocked at how tough and complicated this monster is.  Talking about her son’s injury nearly 3 years ago.  They flew on a small jet with 3 EMT’s to a critical care facility at Ohio state, his head on her lap the whole way.  Tells about the moment that he –hooked up to all the tubes –asked for a computer.  Why?

He wanted to pay his bills.  Happy moment!

Donna programmed the phone numbers of her legislators into her cell phone and called them regularly until they came along and agreed to co-sponsor CDRPA — a process that took many months.  I say again, she’s a rock star.

Next is me.  I’m nervous as hell, but I manage to tell a story that illustrates something I firmly believe: that we all know how to advocate because we had to do so much of it in the hospital.

Then comes a man named David Zacks whose family sat at my table–pretty wife, 7 and 5-year-old daughters, and 3 year old son.  The 2nd grader gets up on the stage with her dad to turn the pages of his talk for him.  He says that like all of us, he was told that this injury is permanent and there is no reason to do anything but get used to the situation and make the most of what you have.  (Inside, I’m hearing the room go hisssssss, but we’re quiet and respectful.)  The little girl makes a face when her dad tells how her sister sometimes introduces him by saying, “This is my dad!  He pees in a bag!”  David’s wife is next to me videotaping this.  His parents are across the table holding the younger children.  David says that for him the cure means being able to hold a beer in his hand . .  . being able to hold his child’s foot tight with one hand while he tickles him with the other.  Ah, there is loss everywhere, everywhere in this room.

The last speaker is Joseph Briseno, a man who was here two years ago, the father of an injured soldier–in fact, the father of the Iraq war vet who has survived the worst set of injuries of any soldier living.  He has a beautiful, warm voice, a Spanish accent, and so much quiet passion.  His son is blind, on a vent, fed with a stomach tube, has a C3 injury and a TBI.  Jesus, God.  The family has been taking care of him themselves for 5 years.  Photos of his family are up on the screen; beautiful daughters with big smiles and the son who is so clearly loved. He makes me ashamed to have ever complained about anything in my life.

He ends by saying that yesterday is a mystery, tomorrow is a mystery, today is a gift.

We’re silent, and then we clap.

Next up is — from Alseres Pharmaceuticals, Dr Mark Hurtt, the Chief Medical Officer to talk about Cethrin

He’s got a slide up about: Patient Profile–11,000 injuries every year, avg age at injury is now 38.

Economics — 4.4 billion is the initial year direct cost of care for acute injuries

Cethrin — it’s a small recombinant protein which inactivates a thing called Rho, it’s been validated in animal models of sci, it’s locally administered at the site of injury, it’s delivered through surgery

Rho is a like a master switch that keeps neurons from re-growing.  Cethrin blocks it.  (My opinion: the best thing about this moment is that someone has taken the trouble to make a fancy little flash movie showing what cethrin is - Alseres thinks they can make money at this!)

He’s talking about a cethrin phase I/IIa trial in acute sci

They provided a single application of cethrin on the dura mater, on complete sci people both thoracic and cervical, all of whom were asia a . . . did follow up at 6 weeks, 3 months, 6 momths, and 12 months.  they were checking for safety and tolerabilty.

There were 48 subjects enrolled at 5 dose levels and they have data on 37.  Most of them were treated within 1-2 days of injury.  The last subjects were enrolled in 11/07 and so the final data won’t be completed (the 12-month followup info) until 11/08.

Safety conclusion: Cethrin is safe.  There were no adverse effects in any of the 48 subjects that were related to the drug.

Last year at w2w we saw the 6 month results, and they’re on the screen again.  It shows that the cervical patients got better more often than the thoracic patients.

Now have more information . . .

Thoracic patients measured at 6, 12, and 26 weeks with doses 0.3, 1, 3, and 6 mg.  The lowest dose did squat.  The results for these time frames are about the same as placebos would produce.  Replace the thoracic patietns with cervical patients, and zoom — the 3 mg dose group had 2 out of 3 patients recovering within the 26 weeks.  For the lowest dosage, the motor scores are still placebo.  But at 1 m and 3 mg, the changes matter.

So, now they have to do a prospective randomized trial — there were no placebos in this one.

The Phase I study was done at 9 locations (Dr. Chapman in Seattle!)  The new study (with placebo and randomized patients) will happen worldwide in the 2nd half of 2008.  There will be 50+ sites, all the subjects will have cervical injuries and be ASIA A.

Question:  Do the patients receive therapy?  Yes, and it’s actually a huge problem, because the more recovery the patients get, the more they want to concentrate on rehab . . . so it becomes impossible to say for sure that the drug is driving the recovery.

Question:  Are you working with chronics?  He says it’s possible that it will work, but right now they’re throwing every guy they have at cervical acute injuries.  His analogy is that in a football line if there’s an opening or a gap, you throw everything you have into that gap.  That’s what they’re doing.