![[info]](http://l-stat.livejournal.com/img/userinfo.gif){kind=small}
I love you always and forever baby..
Here are some things I sometimes wish I could have tattooed on my forehead.
No my husband does not beat me I just bruise very easily.
I can't lose this weight, I am on Prednisone.
I don't feel like it.
Huh?
It hurts.
I'm exhausted.
Yes I know, I just need more exercise right?
Mack
I'm craving carbs.
I'm bored.
Is it normal to have...?
That's a new symptom.
No, there is no cure, yet.
- Mood:
angry
Sorry I have been out of touch.. been feeling like shit honestly.. I am currently fighting with my nurse over this stupid oxygen tank its really making me mad.. i turn it off then next thing I know its broken.. and i have to have the nurse come back over to fix me lol. Speaking of evil here she comes..
Nikki
- Mood:
amused
Anti-CD20 Drugs: Magic Bullet In Treating 'Enigmatic' Lupus?
By Randall Osborne
Editor
Genelabs Technologies Inc.'s $23.7 million financing at the start of October sparked renewed interest in its Phase III drug Prestara for lupus - and in the indication itself, for which a new therapy based on randomized, placebo-controlled trials has not been approved in more than four decades.
Prestara (prasterone), a synthetic form of the human hormone dehydroepiandrosterone, disappointed investors in 2004 with results from an intended confirmatory study, but the FDA has designated as approvable the compound's new drug application. Genelabs has a special protocol assessment deal with the agency for another Phase III trial, but that trial would cost about $25 million, and the firm vowed to use none of the recently raised cash on the lupus effort, focusing instead on its preclinical hepatitis C virus efforts.
"I think the company would like to run a pivotal program for Prestara," Kevin DeGeeter, analyst with Oppenheimer & Co., told BioWorld Financial Watch. "I know [the HCV push] is a priority. Let's say it's more of a priority with management than with investors."
The lupus space is heating up, and last week, Lazard Capital Markets published a 51-page report speculating that biotech and pharma might be on the verge of "slaying the wolf." Prestara wasn't mentioned, but plenty of other players made the grade, as the busy therapeutic area continues to evolve with new candidates. (See BioWorld Financial Watch, June 18, 2007.)
Would-be drugs for the most severe lupus type, systemic lupus erythematosus (SLE) and for lupus nephritis include varying approaches. Some attack cells, and others regulate interactions between cells. Some are immune-system modulators. Cytokines and interferon-alpha make up the targets of some.
Quite a few have reached pivotal trials or will begin shortly, including Rituxan (rituximab), the compound from Biogen Idec Inc., already approved for rheumatoid arthritis and non-Hodgkin's lymphoma; Genentech Inc.'s ocrelizumab, partnered with F. Hoffmann-La Roche Ltd.; LymphoStat-B, from Human Genome Sciences Inc. and GlaxoSmithKline plc; Riquent (abetimus sodium), from La Jolla Pharmaceuticals Inc.; epratuzumab, from Immunomedics Inc.; atacicept, from ZymoGenetics Inc. and Merck Serono; and Orencia (abatacept), from Bristol-Myers Squibb Co.
Lazard is most excited about anti-CD20 antibodies Rituxan and ocrelizumab. The former has become part of the standard of care in CD20-positive NHL and chronic lymphocytic leukemia, and has two trials ongoing - one Phase II/III study called EXPLORER in SLE (due to report data in the first half of next year) and one Phase III study called LUNAR in lupus nephritis (due to report in the fourth quarter of 2008). One of Lazard's consultants described Rituxan as a "base hit for RA, but the drug has the potential to be a home run for lupus," and the firm projects Rituxan sales to hit $4.4 billion this year, thanks mainly to oncology growth, although "lupus could be the next growth driver of this franchise."
A Rituxan boost would be more than welcome to Biogen, which is entertaining buyout offers. The firm reported second-quarter revenues of $773 million and earnings of 70 cents per share, both beating analyst estimates. Most came from $462 million in sales of Avonex (interferon beta-1a) for MS, up 8 percent from last year. Revenues of $231 million from Rituxan, up 12 percent, helped, but both drugs' growth have been slowing in recent periods. Avonex faces challenges in MS from players that include Biogen's own Tysabri, which contributed about $48 million in revenues in the second quarter.
Genentech has ocrelizumab in the works for autoimmune indications where the immunogenicity of Rituxan could be a drawback, and the firm is expected to start Phase III trials with the compound in SLE by the end of this year, and in lupus nephritis the first quarter of next year.
Also in anti-CD20 monoclonal antibodies, Genmab A/S and partner GSK have ofatumumab (Humax-CD20) in Phase III trials for RA, and Immunomedics has veltuzumab in development for NHL, although none of the firms has disclosed plans to try their compounds against lupus.
There's also TRU-015, from Trubion Pharmaceuticals Inc., which saw its stock jump more than 30 percent in September when the firm reported preliminary data from its 276-patient Phase IIb with the compound in RA. Trubion said it was working with partner Wyeth to determine the next steps, but another trial likely will precede the Phase III program.
TRU-015 is described as small modular immunopharmaceutical that binds to CD20 and depletes B cells, much like Rituxan. The compound's structure resembles a monoclonal antibody but with shortened light chains, whereby Trubion intended to gain an advantage in ADCC (antibody-dependent cell-mediated cytotoxicity) over Rituxan, reducing the number of infusion reactions and proving useful against inflammation in cases where complement activation might be part of the problem. Trubion is expected to start signing up patients in a Phase Ib lupus nephritis trial soon.
Lazard is less thrilled about the likes of the Phase III-stage LymphoStat-B for SLE, from HGS and GSK, which is being tried to two studies under a special protocol assessment deal with FDA. The primary endpoint is response rate at week 52, with data expected in the second half of 2009 - but that endpoint in both trials is a novel composite endpoint based on a retrospective analysis of a failed Phase II SLE trial, there is no dose response for the drug and HGS already has reported "unimpressive" Phase II data with the compound for RA, noted the Lazard report.
LJP's Riquent drew little optimism as well, with Lazard's analysts predicting that results from the ongoing Phase III lupus nephritis will match those of earlier Phase II/III trials and fail to meet the primary endpoint of time to renal flare. Designed to reduce autoantibodies to double-stranded DNA and allow for B-cell tolerance, Riquent seems to work well in the first capacity but not so much in the second, Lazard said. A.G. Edwards analyst Albert Rauch, though, called the first data from the Phase III trial "compelling" and initiated coverage of LJP in April with a "buy/speculative" rating and an $11 price objective. The stock was trading at about $4.20 last week.
Combination-biologics therapy could be the wave of the future for "enigmatic" lupus, Lazard speculates, pointing to preclinical data from a trial testing Rituxan with BR3-Fc, the anti-BAFF fusion protein from Genentech and Biogen, in fibroblast-like synoviocytes isolated from RA synovial biopsies. Results were presented at the American College of Rheumatology meeting in 2005.
Published November 5, 2007
What you should know about me and all Lupies
MY PAIN - My pain is not your pain. Taking your arthritis medication will not help me. I cannot work my pain out or shake it off. It is not even a pain that stays put. Today it is in my shoulder, but tomorrow it may be in my foot or gone. My pain is not well understood, but it is real.
MY FATIGUE - I am not merely tired. I am often in a severe state of exhaustion. I may want to participate in physical activities, but I can't. Please do not take this personally. If you saw me shopping in the mall yesterday, but I can't help you with yard work today, it isn't because I don't want to. I am, most likely, paying the price for stressing my muscles beyond their capability.
MY FORGETFULNESS - Those of us who suffer from it call it brain fog. I may not remember your name, but I do remember you. I may not remember what I promised to do for you, even though you told me just seconds ago. My problem has nothing to do with my age, but may be related to sleep deprivation caused by chronic pain. I do not have a selective memory. On some days, I just don't have any short-term memory at all.
MY CLUMSINESS - If I step on your toes or run into you five times in a crowd, I am not purposely targeting you. I do not have the muscle control for that. If you are behind me on the stairs, please be patient. These days, I take life and stairwells one step at a time.
MY DEPRESSION - Yes, there are days when I would rather stay in bed or in the house or die. I have lost count of how many of Dr. patients suffered from Chronic Pain as well as other related illnesses. Severe, unrelenting pain can cause depression. Your sincere concern and understanding can pull me back from the brink. Your snide remarks can tip me over the edge.
MY STRESS - My body does not handle stress well. If I have to give up my job, work part time, or handle my responsibilities from home, I'm not lazy. I may very well be overwhelmed with stress. Everyday stresses make my symptoms worse and can incapacitate me completely.
MY WEIGHT - I may be fat or I may be skinny. Either way, it is not by choice. My body is not your body. My ability to control my appetite is broken, and nobody can tell me how to fix it.
MY NEED FOR THERAPY - If I get a massage every week, don't envy me. My massage is not your massage. Consider how a massage would feel if that charlie horse you had in your leg last week was all over your body. Massaging it out was very painful, but it had to be done. My body is knot- filled. If I can stand the pain, regular massage can help, at least temporarily.
MY GOOD DAYS - If you see me smiling and functioning normally, don't assume I am well. I suffer from a chronic pain and fatigue illness with no cure. I can have my good days, weeks, or even months. In fact, the good days are what keep me going.
MY UNIQUENESS - Even those who suffer from chronic pain are not alike. That means I may not have all of the problems mentioned above. I do have pain above, below the waist, and on both sides of my body that has lasted for a very long time. I may have migraines, hip pain or shoulder pain, or knee pain, but I do not have exactly the same pain as anyone else.
I hope that this helps you understand me, I have shared these thoughts with many "Lupies", as we call our self, and they agree with me.
So when you see someone at the store who gets out of the HANDICAPPED space and they look fine -- DO NOT JUDGE THEM as YOU may Not know THEIR Inner PAIN.
author unknown...
- Mood:awake
