Company To Develop IC Treatment Based Upon Keay's Research

[icnmgrjill]

Editors Note- This is a very INTERESTING development. Dr. Susan Keay's research and discovery of the APF may now lead to a new therapeutic approach to IC. We've been expecting an announcement like this for the past several years and, apparently, Acologix has now agreed to develop the therapy. Fascinating and, honestly, the more companies interested in IC the better! - Jill

ACOLOGIX LICENSES NOVEL TECHNOLOGY FOR TREATMENT
OF INTERSTITIAL CYSTITIS FROM UNIVERSITY OF MARYLAND, BALTIMORE

HAYWARD, Calif. – September 6, 2006 – Acologix, Inc., a privately-held biopharmaceutical company, announced today that it has licensed technology from the University of Maryland, Baltimore, for the potential treatment of interstitial cystitis (IC). A chronic bladder condition characterized by serious pain and increased frequency of urination, interstitial cystitis affects an estimated 700,000 Americans, of whom approximately 90 percent are women. To date, there are no satisfactory treatments for this condition.

Acologix’ license includes patents related to Heparin Binding Epidermal Growth Factor-like Growth Factor (HB-EGF) and therapies targeting a novel human peptide known as anti-proliferative factor (APF). Research led by Susan Keay, M.D., Ph.D., Professor of Medicine, Division of Infectious Diseases, at the Baltimore VA Hospital and the University of Maryland, Baltimore, has demonstrated the potential of HB-EGF and APF in the development of a novel interstitial cystitis therapy. Acologix will sponsor continuing research and development efforts at the Baltimore VA and the University of Maryland, Baltimore.

“Based on the ability of HB-EGF to normalize the physiology of bladder cells from IC patients, we believe it may represent a new way to treat interstitial cystitis,” said Dr. Keay.

David Rosen, Ph.D., Senior Vice President of Research and Development at Acologix added, “Dr. Keay is a recognized leader in her field. We look forward to building on her research as we collaborate to develop a novel therapeutic for this debilitating condition.”

About Acologix, Inc.

Acologix, a privately held biopharmaceutical company, is developing and commercializing innovative biopharmaceuticals targeting osteo-renal diseases, including chronic kidney disease, renal osteodystrophy, bone repair and regeneration, periodontal disease, general dentistry and oral care. Acologix is partnering with Toray Industries, Inc. of Japan on the development and commercialization of AC-820 (or TRK-820) for the treatment of uremic pruritus in dialysis patients. AC-820 is being studied in a European Phase 3 pivotal clinical trial, with a Phase 3 trial planned to launch in the United States. AC-100 (Dentonin®), a novel small peptide with dental, periodontal and orthopedic applications, has been studied in two recently concluded Phase 2 clinical studies, one in dental restoration procedures and another for the repair of periodontal defects, and further studies are planned. Acologix is also developing AC-200 (Phosphatonin) to treat hyperphosphatemia and subsequent clinical problems associated with chronic kidney disease. For more information go to www.acologix.com.

This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. Acologix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Acologix’ business.

[ICLori]

Woo hoo! It's about time someone paid attention to this research and tried to look into a treatment based on it!

Thanks for posting this, Jill, this gives me more hope than just about anything I've read lately!

Blessings,
Lori

[vm]

VERY exciting! :) :) :) :) :)

[Trishann]

I do hope they keep searching for possibilities of what might be causing IC.
Thank God they are not giving up on it.

Hug, Trishann

[diany]

I NEW IT THAT GOD IS WITH US!!:pray:

:woohoo:
:woohoo:

[green_the_fish]

Finally, they are going to develop a treatment based on the anti-proliferative factor we've all been hearing about for so long!

:bow: :bow: :bow:

[ICNDonna]

Definitely good news.

:)
Donna

[mary124]

Good news!!:woohoo:

[sweetangel2080]

wow, how long does it take from licensing to available to us?

Exciting stuff!

[Phillyman316]

Wow that's good news.Even though its very early Would it be a pill or something like DMSO?

[marsi4]

I pray it is soon, because they've been telling us that they are close to developing new treatments since the 90's and they've come up with nothing so far. I'm desperately hoping that they come up with a new effective treatment soon because I'm so close to giving up.

Marsi4

[wolfaleena]

Thanks Jill for posting this.I don't know if I would have been aware of this, had you not posted this news release.. thanks!
I was a part of the University of MD study and i did test positive for the APF (anti-proliferation factor) in my urine. That was at least 6 or 7 years ago. I kept wondering if anyone was going to do anything with this data.
I met Dr. Susan Key during the initial interview for the study and she was a fascinating person. I am just wondering how long it will take now. Patience is a virtue???

[wolfaleena]

Maris4:
Don't give up, honey!
Believe me, I understand how you feel ....Believe me.... Don't give up hope!

[diany]

Wolfalena Do You Think That This Happens Very Soon?? The New Treatment, How Many Years?

[Kimchi]

This is GREAT news. Someone is paying us serious attention. Also, never give up hope. Someday, our daughters and friends will have cures for this awful disease and our suffering won't be for nothing!

[wolfaleena]

Hi Diany:
I really don't know..
i was just a patient in the study and my urine did test positive for the APF.
I just sent an email to the company to see if they needed any ic patients for trials.. i have no idea what stage they are in.... Maybe they are further along then we think..... it sounded like they were just starting, but i really don't know.. My hope is that they are further along, but i am sure we will find out something soon..
I hope you are feeling okay today..
It is raining here today and i am in a lot of pain, but a friend just called me and told me that they all have been praying for me and that "everything is going to be okay." I thought that was really sweet and it is making me bear my pain a little better...

[mela414]

good news!
Do they normally test for APF? I don't remember ever being tested for that in my urine.
I hope they figure out something soon......diet helps a lot but we really need something that allows the baldder to heal.

[wolfaleena]

I volunteered as a patient in a clinical research study at the university of maryland where dr. Keay was researching this APF in IC patients. it was at least 7 years ago. She was tesing the urine of ic patients for this research project. So i volunteered. One of the things she was looking for was the APF. My urine tested positive for anti proliferation factor. APF.. This was a Clinical Study that i was involved in for this specifically and that is why my urine was tested for it. The doctor was doing research on it at the time..
Then i had to submit my urine every month or week i don't remember it was awhile ago and also submit a voiding and pain diary.. If I remember correctly, I think they were looking for a correlation between pain and other symptoms and the measurement and or concentration of the APF. I can't be sure of the details of the research study, I would have to look it up.. it was a long time ago at least 7 years ago!! I always wondered whatever happened to this research... She seemed like an amazing doctor.. Well, I am sure glad to hear the news about this company wanting to pick up the ball and run with it..
I don't know how long this will take or what they will come up with .. I just know that i tested positive for the APF and that was the last i heard of it..
Am hoping that something really good comes of this~~
(hoping it won't be too long)

[mela414]

Souds interesting. Sis they ever post the results of that study?
7 years ago....boy!! it sure does take a long time for new treatments to finally make it to the patients. Thanks for the info.

[darlene]

I was also part of the study. I sent both urine and blood samples. I soooo hope this will work!

[Claredale]

I have a question. My doctor (who I haven't seen for very long) I have been spoiled by Dr. Ragi Dogweiller for so many years, but she now lives in Knoxville. I suggested that Dr. Ragi used Valium to insert into my vagina that would help with my spasms. I noticed that I was having a problem with it dissolving and mentioned it to my doctor. He prescribed a med called Diastat Acudial 10 mg gel kit. My husband went to 4 different pharmacies trying to get it filled and was told that it was a compound and had to be mixed, but Walgreens mixed it up for him. I am to use 2 a day at $15.00 a day. If I knew that I worked, believe me, Iwould pay put when I researched what the meds do. They are for epilepsy.

I called my doctor and of course got his assistant, who must have a problem with me because everytime I talk to her she has an attitude. I had a great relationship with my other doctor's office and always got real answers like she is in surgery, but she will let her know I called and I hope you feel better. etc. This doctor' asst called me at 5:00 today (right at closing time) I asked her if the doctor just called in enough meds just so I can see if they work. Dr. Ragi would always give me samples just because everyone handles meds differently. Today she said that she was calling in the exact amount that the doctor told her to and it was up to me to decide if it was too much or not. I know I am a patient, but I really like the doctor and I feel that he sympathizes with me, but I just need some advise.

Thanks for your help!!!!

[MakinIT]

Is this APF a marker for IC or just one of the forms of IC? Just curious b/c it is such a wierd disease...Ie: mine is definately allergy related, my first uro said he had never seen so many Mast cells in 2 such small places. (biopsies..dang they hurt) Anyway, I too am curious as to how they would deliver "the goods" to us. pill, shot, cath med? (I go in for monthly cocktails of heparin, steroid, and a local numbing agent that makes it hard for me to feel when I have to pee...Thus I have to cath myself the first time after they do this, usually EIGHT hours later when the pain in my lower pelvis is so intense and I say to myself...DUH?..I need to wear a red bracelet on those days) Glad to hear we aren't forgoten but I'm sure it will be expensive and my insurance co. will love me even more.

Tracey

[inky]

hello,

haven't been here for awhile... 99% positive i don't have ic but 100% sure i do have pfd.
just read this thread and found an interesting link re:
estradiol enhacing heparin-binding epidermal growth factor:

http://ajpcell.physiology.org/cgi/reprint/288/4/C813.pdf

just thought it was interesting because of all the info relating lack of estrogen and ic.

hope everyone has a happy and healthy new year!

inky

[barbour1]

What's pfd?

[MakinIT]

PFD: Big owie...if you have IC you prob have it and don't realize it. Pelvic floor Dysfunction. all the muscles in your pelvic floor get sore and spasm, which complicates the bladder, bowel, vaginal and sex..including even clitoral spasms..not the fun kind either (get yer minds outta the toilet) Um...they have specialized physical therapists for that...women...I've had 2 rounds in 4 years plus some general strengthening. You can read more about it further down. There is a section on it.

[slukic]

Jill or anybody else..

do we know where we are standing with confirming that Antiproliferative factor (APF) is a marker of IC? How about testing it?
A lot of experts are talking about it - Vicki Ratner for example said on the radio talk show that it should be soon accepted as a test for IC.

What made me worried is the most recent research Susan Keay published
on Feb 2007 "Changes in Urine Markers and Symptoms After Bladder Distention for Interstitial Cystitis. " (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17222633)

because it said that although APF did improve after cycto/hydro the symthoms did not. Is that means we are still not on the right path?
Is this a step back?
And if not - why is it taking so long for APF to be accepted as a IC test?
It is non-invesive.. much better then anything on the market...

I am one of those that is desperately looking for a test to confirm or not the IC. I do not have bladder pain mostly urethral urgency- Dr. Moldwin diagnozed it as "non-specific urethritis"..for now.

Please let us know!!

[wolfaleena]

http://www.acologix.com/news/2006/090606.html
Check out this link
i was involved in a study about 7 years ago at the university of maryland (as a patient) and i met with her and part of the study was testing the urine and level of pain, etc ... and at the time she did test me for the Apf as part of the study and my urine was positive for the factor .. (i had alread been diagnosed with IC through hydrodistention some years prior to the study.
but check out the link above . there is some type of collaboration being done with this company acologix and the university of maryland with the APF.
That is all I know presently.
Anyone else have any good info:
We all could use some good news .
Keep the Faith.

[mayray]

I too was in the study at U of MD and tested positive for APF factor (protein in urine). I control my symptoms with elavil but am always checking in on any progress done in this field as it would be wonderful to find out what causes the body to produce the protein. If the protein could be gotten rid of, then no more need for meds (in my case). :woohoo:

[slukic]

Inky,

I saw the article - it is very academic and specific. So it will take a while to digest. I am however very much interested in connection with IC and estrogen.
I believe my urinary problems started with my menstrual cycle irregularities which are caused by lower level of estrogen (normal still but on the border)

[mightyjoe]

My wife was diagnosed last wednesday and she will be participating in a research study involving elavil...she was also asked to participate in a study based at the Univ. of Maryland where she would give a urine sample and it would be tested and we were told it had to do with markers in the urine...I wonder if this is the same study that you guys are referring to...I think she mentioned that it has been ongoing for some time now...my wife will be sending her sample so they can use it for that study, where they will test it and store it...hopefully they can find something out with this study!

[slukic]

Yes indeed this is it!
Univ. of Maryland has the hottest research right now.. she is luckly I believe that she was asked for to be part of it.
Can you let us know - how was she recruted? How was she diagnosed?
How long will it take them to tell her about the research results?
(I am assuming they will confirm the diagnose showing the level of APF and the rest fo the markers)
Do you live in the Baltimore area? or you will be sending urine samples?

Thx! PLease let us know...

[mightyjoe]

We went to see Dr. Hanno at HUP in Philly and she was a perfect candidate for the elavil study because she had never technically been treated before and he and the research dr also mentioned a study where all she had to do was submit a urine sample for analysis and storage at U of MD...she said ok. She was diagnosed by exclusion by Dr. Hanno...she had had about every test from every other specialty so that along with him questioning her and giving her a pelvic led to him diagnosing her (her biggest symptoms are pain, spasming, burning, and pressure)...we brought everything with us (lab results, test results, her different diaries, etc...). Not sure how long it will take to here any results but I will let you know as soon as I do...we weren't told that much except that they would be looking for markers in the urine. Anyway, we live in south jersey about 15 minutes from center city Philly so we will be sending in samples...thanks for your reply, it sounded so similar that I thought these must be the same just didn't know it had been going on for that long.

[sweetangel2080]

what is the news with this research?
earlier on this year a company had planned to develop medication didn't they?

[Elvis70]

http://www.wipo.int/patentscopedb/en/fetch.jsp?LANG=ENG&DBSELECT=PCT&SERVER_TYPE=19&SORT=1221842-KEY&TYPE_FIELD=256&IDB=0&IDOC=1217031&C=10&ELEMENT_SET=B&RESULT=1&TOTAL=3&START=1&DISP=25&FORM=SEP-0/HITNUM,B-ENG,DP,MC,AN,PA,ABSUM-ENG&SEARCH_IA=US2006009936&QUERY=%28PA%2fUNIVERSITY+AND+PA%2fOF+AND+PA%2fMARYLAND%2c+AND+PA%2fBAL TIMORE%29+AND+%28IN%2fKEAY%2c+AND+IN%2fSusan%2c+AND+IN%2fK%29+

[Elvis70]

http://www.wipo.int/patentscopedb/en/fetch.jsp?SEARCH_IA=US2004021239&DBSELECT=PCT&C=10&TOTAL=3&IDB=0&TYPE_FIELD=256&SERVER_TYPE=19&QUERY=%28PA%2FUNIVERSITY+AND+PA%2FOF+AND+PA%2FMARYLAND%2C+AND+PA%2FBAL TIMORE%29+AND+%28IN%2FKEAY%2C+AND+IN%2FSusan%2C+AND+IN%2FK%29+&START=1&ELEMENT_SET=B&SORT=1221842-KEY&RESULT=2&DISP=25&FORM=SEP-0%2FHITNUM%2CB-ENG%2CDP%2CMC%2CAN%2CPA%2CABSUM-ENG&IDOC=1139461&IA=US2004021239&LANG=ENG&DISPLAY=DESC

[ouch_a_lot]

No news on the website for a while....

[mayray]

I live in Maryland and have been to the U of MD research center. I see Dr. Chai but all of the docs, Warren and Keay, are excellent. I have been in remission for 8 years due to elavil but I do carry the APF factor and this new development is very interesting. The difference between it being approved in other countries and FDA approval can be years. I would be very interested in trying this when and if it is approved.

[mayray]

i went to the acologix website and clicked on the info e mail for information and it came back saying "no such e mail"

[wolfaleena]

Is dr. Chai a urologist?

[mayray]

Yes Dr. Chai is a urologist at the University of Maryland who practices with Dr. Keay.

[Milonguera]

This is very interesting news, although the article in the original post dates back to Sept. 2006 - I wonder what's been happening this past year and a half? I wonder if there is a good resource where the public can access information on the most recent scientific studies and developments for IC?

I checked out the above link to the 2007 study concerning the association between markers and symptoms (thanks for sharing!). It's really a very brief summary that doesn't go into much detail, but it sounds like the results suggested that significant improvements in APF and HBEGF didn't correlate to improved symptoms. I'm left wondering, how long after the distensions were the patients' symptoms re-evaluated? Was it enough time to allow the bladder linings to actually heal? Maybe it's a matter of the length of time you can keep these chemical markers at bay, to allow the tissues to regrow. Or, if tissue regrowth doesn't improve symptoms, maybe this suggests that IC is more of a neurological disorder than a physiological one?

I'd like to stay on top of the latest developments on this front, and I hope it gains momentum - seems like there could potentially be hundreds of thousands of patients willing to pay almost anything for a solidly successful IC treatment, which I would think should tempt research institutions and pharmaceutical companies to invest in it!

[mcdoll]

I think I read somewhere that this treatment didn't end up working.

[mcdoll]

You know what, I'm not sure if it was this treatment that wasn't working. I read so many things. It might have been something else. I still have a nagging feeling there was some study done which didn't work related to this, but maybe they're trying other ways.

[jvr]

Hi,

Does anyone know what ever happened to this company creating a treatment based on Dr. Keay's research on APF? I see it was almost 3-4 years ago and I don't see any mention of anything on their website and havent' heard anything further since....
I did see a few days ago on the ICA webiste an announcement that another company named Celek Pharmaceuticals, Inc. and Dr. Keay were "awarded $159,500 to evaulate the efficacy of a new therapy for IC." This sounds exciting...

Jill:hi:

[wolfaleena]

hi jill do you remember what it said. this is so crazy that everything is moving a such a snail's pace. if someone really wealthy and famous had the disease in it severe form they might be rushing to find a cure
maybe just because i feel particularly down today i am saying that. i had a bladder infection a few weeks ago in addition to ic and have been suffering terribly and also had a yeast infection. my vulva is irritated and sore and hurts and it has been going on for a few weeks now. all i have been doing is staying in bed. i feel like life is just passing me by.. i keep trying to get up, but i don't feel well at all!

[jvr]

Hi,

It just said that they were awarded a sum of money to evaluate the efficacy of a new therapy for IC. It's on the ICA webiste. Just go the the research category and you will see the announcement. I would post the link, but I'm terrible at all this computer business.:lmao: You can also go to the Celek Pharmaceuticals webiste and see some info there too. No wonder you're suffering so much right now...a bladder infection with IC is no fun.:tsk: That has been some of the most painful episodes with my IC when my bladder is trying to heal after an infection.
I understand what you're saying about everything moving at a snail's pace. Oddly though, I feel more hopeful than ever about the future of IC. I do think better treatments will come to be, but when your feeling bad, I know they can't come soon enough:(
Jill:hi:

[wolfaleena]

hi thanks for your kind words .. and yes, i am having a hard time healing after this bladder infection. thank you for your input, at least i am not the only one that has had a hard time after a bladder infection. i have felt so awful for weeks now.
actually you are right there has been a lot more research going on now more than ever and i do feel hopeful too.. it is just difficult like you said when you are trying to heal after a bladder infection and your bladder is already so messed up. it is like you almost can't heal...because the bladder doesn't have the capacity to heal. oh well, i just have to carry on. what is the alternative, not very attrative.. i just feel so badly for my husband, he is alone a lot of the time because i am in bed and he worries so much.