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 | Clinical Trials: MN-166 Enters Phase II trials in US |
MediciNova announced today the completion of enrollment in a sizable (297 patients) Phase II clinical trial of a drug they call MN-166. There are a few interesting things about MN-166 that make it particularly noteworthy (of course, we find all potential new treatments inherently noteworthy!), including the following:
- It is an orally delivered drug (!)
- It has already been used in Asia for 16 years (!) to treat asthma and other cerebrovascular disorders, and the company indicates that post-marketing data for the 15,000 patients that have taken it for those indications demonstrates it to be safe and effective
- Though Phase II is a two-year trial, partial efficacy data will be released next year at this time
- There is a concurrent Phase II trial in Eastern Europe that has a 6 month head start on the US version.
- MN-166 is said to inhibit leukotriene activity, phosphodiesterases and nitric oxide synthase, which are generally accepted as inflammatory mechanisms involved (somehow) with MS.
In other words, this is a promising treatment with a needle-free delivery mechanism and long history of product safety. Of course, the FDA trial process is quite lengthy and given the current stage (early Phase II), the drug would be unavailable for general use by MS''ers for at least 4 more years. The best takeaway at this point is that the days of injectable MS drugs being the *only* effective option are seriously numbered, and becoming increasingly so by the day.
Please click "read more" for more details.
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Posted by Administrator on Monday, February 06 @ 20:05:31 CST (7751 reads)
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 | Clinical Trials: IGIV for the Treatment of Multiple Sclerosis |
 Bayer is researching IGIV as a treatment for MS. Note that a few studies have already been done showing that this is an effective treatment, but the dosage (and efficacy) is to be determined in this trial. Note that, like Antegren, this is a monthly IV-- hope for an end to frequent pinpricks is in sight...
"Bayer HealthCare LLC, Biological Products Division (Bayer BP), has closed enrollment in the first industry-sponsored trial to evaluate immune globulin intravenous (IGIV) for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under an Investigational New Drug application (IND) submitted to the U.S. Food and Drug Administration (FDA), the multi-national clinical trial will assess the efficacy and safety of Gamunex®, Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified, in RRMS.
Other data in this field, including published studies, point to IGIV as potentially effective in the treatment of RRMS. Most recently, a retrospective analysis of 300 patient medical records conducted in Germany and Austria do*****ented use of IGIV in the treatment of RRMS. The analysis showed IGIV significantly reduced the annual relapse rate by 69 percent compared with the two years prior without IGIV treatment. In addition, a meta-analysis of four randomized, placebo-controlled trials of IGIV in patients with RRMS conducted in Europe and published in the journal Neurological Sciences in 2003 showed positive results for primary endpoints, including relapse rate, new MRI lesions, and disease progression. The author concluded IGIV is an alternative second-line treatment to approved therapies in relapsing-remitting MS, but the ideal dosage of IGIV still needs to be determined..."
Click "read more" for the full article...
Note: We have recently been notified of the following change:
"Talecris Biotherapeutics acquired the contributed
assets of Bayer HealthCare, LLC, Biological Products Division''s plasma business, and launched its worldwide therapeutic proteins business on April 1, 2005. All plasma-derived products - including Gamunex1, Prolastin2, Plasbumin3, the
hyperimmune line (Fraction II)4, Koate DVI5, Plasmanate6, and Thrombate III -
related facilities, and employees are now functioning under the name Talecris Biotherapeutics.
The Kogenate? product line remains with Bayer Biological Products.
www.gamunex.com
www.plasbumin.com
www.prolastin.com
www.talecrisusa.com
www.talecrisdirect.com"
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Posted by Administrator on Tuesday, May 11 @ 19:37:42 CDT (3516 reads)
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 | Clinical Trials: Campath for Multiple Sclerosis Completes Phase III Enrollment |
 Some news on Campath, a chemotherapy treatment for multiple sclerosis that has shown good success in earlier trials and has now finished enrollment for Phase II. Note that after Antegren, Campath is the next next multiple sclerosis treatment to be up for release.
"ILEX(tm) Oncology Inc. announced today that it has met its enrollment target of 240 patients in its global, multi-center Phase II trial of CAMPATH(R) (alemtuzumab) in previously untreated relapsing/remitting multiple sclerosis (MS). The Company announced in January that it was expanding the size of the trial from 150 patients to 240 patients based on growing interest among investigators and patients, as well as repeated recommendations of the independent data safety monitoring board to continue the study...
In a CAMPATH pilot study reported at the 2003 American Academy of Neurology annual meeting by Professor Alastair Compston, chairman of neurology, University of Cambridge, Addenbrooke''s Hospital, Cambridge, United Kingdom, 17 previously untreated patients with early, active relapsing-remitting MS without progression or severe disability experienced a near-complete reduction in annualized relapse rate, and in no patient did disability increase."
Click "read more" for the full release...
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Posted by Administrator on Friday, April 23 @ 02:43:17 CDT (6241 reads)
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 | Clinical Trials: Daclizumab (possible MS therapy) Passes Phase II for Asthma |
 Just an indication on a possible future therapy...
"Protein Design Labs, a Fremont-based biotech company, reported positive results on Monday from a clinical study of a drug to treat asthma.
The Phase II study of daclizumab, already in use to prevent organ rejection in transplants, helped patients whose chronic asthma is not well controlled by high doses of standard inhaled coricosteroid therapy...
PDL is conducting a Phase II clinical trial of the drug in moderate-to-severe ulcerative colitis and expects to report results from the trial by June 2004. Preparatory work continues for a PDL-conducted clinical trial of daclizumab in multiple sclerosis."
Click "read more" for the full story...
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Posted by Administrator on Monday, March 15 @ 17:11:41 CST (2108 reads)
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 | Clinical Trials: Caprivax (Goat Serum) Drug Trial Recruiting |
More information on the goat serum (Caprivax) front-- including a trial. Interestingly enough, they are ONLY accepting secondary progressive patients. Since the medical visits are weekly, they are giving strong preference to people who live near the study (London).
"A placebo controlled, double-blind randomised trial of [Caprivax (goat serum)] is being carried out by Dr David Barnes at the Atkinson Morley Wing of St George''s Hospital in Tooting, London SW17.
Anyone wishing to be considered must have secondary progressive MS. They must be able to walk but to have noticed a significant decline over the last year. This must be confirmed by their neurologist who should be asked to write a letter of referral to Dr Barnes. Direct applications cannot be accepted."
Click "read more" for the full article...
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Posted by Administrator on Sunday, February 01 @ 14:58:11 CST (8003 reads)
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 | Clinical Trials: Antegren Successful in Phase III Crohn''s Trial! MS next... |
Antegren, the next hope in MS treatments, has just been proven effective in its Phase III trial for Crohn''s, an autoimmune disease of the digestive tract. This bodes extremely well for the multiple sclerosis indication of Antegren, also in Phase III. Note the positive words regarding "other autoimmune diseases"... No doubt about it, Antegren is almost here folks...
"Elan Corporation, plc and Biogen Idec today announced that the Phase III maintenance trial of ANTEGREN® (natalizumab) in Crohn''s disease met the primary endpoint of maintenance of response...These natalizumab data also reinforce the importance of studying its novel mechanism of action in the treatment of other severe and chronic inflammatory diseases. We expect to share the data from this study at a major medical meeting in the first half of this year...Concurrently, two Phase III studies in multiple sclerosis (MS) are underway. AFFIRM (natalizumab safety and efficacy in relapsing-remitting MS) will evaluate the ability of natalizumab to slow the rate of disability in MS and reduce the rate of clinical relapses; SENTINEL (safety and efficacy of natalizumab in combination with AVONEX® (Interferon beta-1a) in patients with relapsing-remitting MS) will determine if the combination of natalizumab and AVONEX is more effective than treatment with AVONEX alone in slowing rate of disability and reducing rate of clinical relapses.
"We are confident in the potential of natalizumab as a therapeutic option for patients with chronic immunologic diseases," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "We look forward to working with the regulatory agencies to determine the next steps."
Please click "read more" for the full story...
Note: Another press release notes: ""We are extremely encouraged by these findings," Elan said in a statement.
The market has high hopes for Antegren, which is being tested on both Crohn''s Disease and multiple sclerosis.
Elan said it would now discuss the trial data with regulatory authorities in the United States and Europe. "
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Posted by Administrator on Thursday, January 29 @ 02:16:23 CST (3615 reads)
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 | Clinical Trials: New Drug Zonegran (Synthetic Venom) May Relieve Serious Pain |
Another new drug from Elan, who is currently also running trials for Antegren for MS (in conjunction with Biogen).
A synthetic form of sea snail venom can ease pain in cancer and AIDS victims who get no relief from morphine or other conventional painkillers, a study found.
Laboratory research has found evidence that the venom that the snails inject to immobilize their prey might have beneficial effects on some heart problems, strokes, central nervous system disorders and other ills.
Click "Read More" below for the full story...
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Posted by Administrator on Wednesday, January 07 @ 01:06:21 CST (2627 reads)
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 | Clinical Trials: Laugh at Funerals? Avanir''s NeuroDex intended for Emotional Lability Treatment |
"[Sufferers of neurological disorders] can face daunting physical rehabilitation challenges that may be complicated by uncontrollable outbursts of emotions, such as laughing or crying. This condition, called pseudobulbar affect (PBA) or emotional lability, may affect up to one third of the four million stroke survivors in the U.S. today.
PBA affects a diverse population of patients with neurologic disorders, including those with Alzheimer''s, multiple sclerosis, Lou Gehrig''s disease or ALS, Parkinson''s, and those with neuronal damage following stroke or traumatic brain injury. While the underlying causes of PBA vary from patient to patient, those with the condition experience uncontrolled emotional outbursts and inappropriate responses to various situations. In the simplest terms, PBA can cause a stroke survivor to laugh at a funeral or cry at the circus."
Click "Read More" below for the full story.
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Posted by Administrator on Monday, December 29 @ 15:29:58 CST (2871 reads)
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 | Clinical Trials: Millenium begins test on inflammation treatment MLN3897 |
Millennium Pharmaceuticals Inc. in Cambridge has launched Phase I clinical trials for a drug intended to reduce inflammation in conditions ranging from rheumatoid arthritis to multiple sclerosis and psoriasis. The drug, MLN3897, is the first to reach clinical trials stemming from an alliance with Aventis Pharmaceuticals Inc. in Bridgewater, N.J., formed in 2000 to find new therapies for inflammatory diseases.
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Posted by Administrator on Monday, December 22 @ 18:04:44 CST (2696 reads)
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 | Clinical Trials: A New Drug for Spasticity in Multiple Sclerosis |
A new study shows that the popular anti-epileptic drug levetiracetam reduced phasic spasticity, which is marked by spasms and painful muscle cramps, in 100 percent of patients with Multiple Sclerosis in a small clinical study. Spasticity is a key factor in many MS patients'' loss of the ability to walk.
"It''s amazing how many MS patients can''t walk, can''t move, and you treat their spasticity and they''re fine," said Dr. Kathleen Hawker, assistant professor of neurology at UT Southwestern and lead author of the study. "What''s nice about these drugs is that they also work for nerve pain, which in turn improves the patient''s mood, so we can use one drug for three things instead of prescribing pain killers and antidepressants in addition to the spasticity therapies."
Read the full article by clicking "Read More" below.
Note: Besides the outstanding efficacy, also interesting is the very low side effect profile versus current treatments.
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Posted by Administrator on Monday, December 15 @ 19:49:18 CST (3299 reads)
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 | Clinical Trials: Genzyme Announces Start of Phase 1 Trial of Genz-29155 for Multiple Sclerosis |
Add another drug to the pipeline!
Genzyme Corporation announced today that physicians have treated the first participants in a Phase 1 clinical trial to test the safety of Genz-29155, a small molecule developed by Genzyme for the treatment of multiple sclerosis.
...
Genz-29155, which was discovered through high throughput screening at Genzyme, has shown an ability in vitro to inhibit some, but not all, of the activities of tumor necrosis factor (TNF), a protein active in the regulation of certain immune responses. In vivo, Genz-29155 has shown potential to have an effect not only in models of multiple sclerosis, but of other immune- mediated diseases as well.
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Posted by Administrator on Friday, December 12 @ 13:37:33 CST (2797 reads)
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 | Clinical Trials: Tularik Initiates Phase 2 Clinical Trial of T487 in Psoriasis (MS to follow?) |
Although they are going after Psoriasis first, this drug has potential for treating Multiple Sclerosis down the road...
Tularik Inc. today announced the initiation of a Phase 2 efficacy and safety study with T487 for the treatment of patients with psoriasis. T487 is an orally-administered therapy that has a novel mechanism of action and is expected to reduce inflammation in conditions such as psoriasis.
T487 acts by binding to CXCR3, a receptor found on the surface of lymphocytes. The binding of T487 to CXCR3 inhibits the migration of lymphocytes into inflamed tissue. Thus, T487 is expected to provide symptomatic relief and block the progression of diseases such as rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis and psoriasis. In preclinical studies, T487 blocked immune cell migration and demonstrated excellent potency, high selectivity and good oral bioavailability. In Phase 1 studies, all doses of T487 were well-tolerated and no serious adverse events were observed.
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Posted by Administrator on Wednesday, December 10 @ 15:14:17 CST (2280 reads)
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 | Clinical Trials: First Patient Enrolled in new Betaferon Study |
Schering AG, Germany announced today that the first multiple sclerosis (MS) patient has entered the second phase of the BEYOND trial. This compares the efficacy of a new, higher-dose Betaferon® (500 mcg) with Betaferon 250 mcg and glatiramer acetate (Copaxone) in patients with relapsing-remitting MS. Recently, the company announced positive safety and tolerability data from the first phase of the study program examining Betaferon 250 mcg and Betaferon 500 mcg.
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Posted by Administrator on Tuesday, December 09 @ 14:02:53 CST (3078 reads)
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 | Clinical Trials: Clinical Trial for Low Dose Naltrexone & Crohn''s Disease |
Crohn''s is another autoimmune disease and treatments can be applicable to multiple sclerosis (e.g., Antegren).
"Dr. Jill Smith is currently enrolling patients in a 4 month study to test the effectiveness of a low dose of naltrexone in offering relief to patients suffering from symptoms of Crohn''s Disease."
Please see the following link for more info:
http://www.hmc.psu.edu/colorectal/research/naltrexone.htm
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Posted by Administrator on Wednesday, November 12 @ 14:32:58 CST (3661 reads)
(Read More... | Score: 5)
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