It was 2007 when an article in the U.K. had taken Daval International Ltd. to task for not doing clinical trials on their drug, Aimspro. The article had brought up how, in seven years, only two very small trials had been done and of them, “one was inconclusive and the other was stopped early.”
Aimspro is only available in Britain under their “compassionate-use” regulations and that means, like CCSVI, patients have to use their own money to receive treatment. No health insurance companies (or state funded health regulators) will touch a non-FDA or non-MHRA approved therapy.
Since then, phase II of the multiple sclerosis (MS) trial has been completed with decent enough results published Monday but they still need peer-reviewed. It’s preliminary at this point and there is still a bit of a debate going on.
Aimspro is a drug that is derived from a goat ‘s blood and for a while, that was all Mrs. Haven from Lima could focus on. “I have never heard of such a thing and I really don’t know how to feel about it,” she said after a pausing when she was informed of what Aimspro was.
“Of course, the obvious if it works please get it out there, but,” and here she pauses again. “Goat’s blood? Huh, and here I feel awful enough for the mice that are given MS so we can study them; much less penning up a bunch of poor goats and taking their blood.”
The goat blood/serum results of the 140 patients were pretty decent:
- 122 patients improved in at least one of eight different areas of symptoms, including 40 who improved in two areas
- 27 patients improved in three areas, and 33 improved in four or more
- 16 patients showed no improvement
- 2 patients got worse
Each patient, ages 25 to 68, had received Aimspro for two weeks to three years. The doses ranged from twice weekly to once every two weeks and Christopher E.G. Moore, MSc, MBBS, of Queen Alexandra Hospital in Portsmouth, England stated, “[results] indicate a dose-response relationship between the total dosage received and the number of clinical areas with improvement.”
It is hard telling how this is going to end considering the issues the study had. There were no MRI lesion counts, no Expanded Disability Status Score (EDSS) values completed, Moore is lead author and owns stock in the company and a co-author actually works in the company.
When the lack of MRIs was brought to Moore’s attention, he commented that MRIs are not part of regular health care there like it is here in the United States.
So, the researchers complete two phases of a clinical study with no objective data; which means, it will not matter how well people are saying they are doing after taking this serum, they are going to play hell making it through MHRA approval; much less get that of the FDA here in the States.
Source: Examiner.com © 2006-2013 Clarity Digital Group LLC (04/06/13)
A controversial product derived from goat blood appeared to benefit patients with secondary progressive multiple sclerosis in an open-label study, researchers said here.
Among 140 British patients receiving up to 3 years of treatment with the proprietary extract, called Aimspro, in clinical practice, 100 showed improvement in at least two separate areas of MS-related symptomatology, according to Christopher E.G. Moore, MSc, MBBS, of Queen Alexandra Hospital in Portsmouth, England.
Although Moore and colleagues did not calculate Expanded Disability Status Score (EDSS) values for patients in the study, the clinician-estimated improvements in two or more symptom areas ought to translate to decreases of at least 0.5 points in EDSS scores, they argued.
The study results were presented at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
Aimspro includes a cocktail of immunoglobulins targeting human proteins, including proinflammatory human leukocyte antigens, according to the product's developer, Daval International Ltd. of Eastbourne, England. It also upregulates anti-inflammatory cytokine, the firm said. The drug is administered by subcutaneous injection in doses of 4.5 mg at individually determined intervals, most often twice weekly.
It was originally developed as a potential anti-HIV therapy, but Daval later shifted emphasis to other conditions including MS as well as systemic sclerosis and amyotrophic lateral sclerosis. Although AIMSPRO has never been approved anywhere for marketing, the firm is allowed to sell the drug in Great Britain under the country's compassionate-use regulations.
Specifically, Daval is allowed to sell the drug for use in individually named patients with a physician's prescription citing "unmet medical needs." It is produced in a licensed, government-inspected facility in Britain from serum taken from a herd of certified prion-free goats, according to Daval.
Aimspro's de facto availability in Britain has sparked controversy, with one newspaper reporting on patients "spending their life savings [on an] unproven goats' blood treatment."
Moore examined records of 140 patients who received the drug under the compassionate use program. The records analyzed included clinician notes, patient diaries, and questionnaire responses.
Moore determined whether improvement was present in each of the eight areas evaluated in the EDSS, using a scale that awarded two points for "marked" improvement, one point for "some" improvement," and so on to negative two points for marked worsening. "Marked" improvement in this scheme would correspond to a decrease of -0.5 EDSS points, he said.
Mean age of patients in the study was 47 (range 25 to 68) and each had received Aimspro for 2 weeks to 3 years. Dosing ranged from twice weekly to once every 2 weeks. The total number of doses ranged from three to 150. The mean and median duration of disease were both 14 years.
None of the patients were taking conventional disease-modifying MS drugs while on Aimspro.
Of the 140 patients, 122 showed improvement in at least one EDSS area, Moore reported, including 40 who had improvement in two areas, 27 improving in three, and 33 improving in four or more.
Sixteen patients demonstrated no benefit and two showed overall clinical worsening.
Data presented by Moore indicated a dose-response relationship between the total dosage received and the number of clinical areas with improvement.
Missing, though, were any data on objective measures of disease activity such as MRI lesion counts. Moore told MedPage Today that they had not been performed as part of the patients' regular care. He said MRI scans are not part of standard practice in the British system, unlike in the U.S.
Daval has completed a placebo-controlled, double-blind phase II trial of Aimspro in MS patients with measures of bladder function as primary outcomes, but specific results have not been reported publicly, Moore said.
According to Moore, 4 weeks of treatment did not improve bladder function, but secondary endpoints involving other MS symptoms such as walking impairments showed hints of benefit that grew during an open-label extension.
Syed Haq, MBBS, PhD, of Daval, told MedPage Today that the company had recently identified a biomarker that correlates with clinical MS severity and that is altered with Aimspro. He said he could not name the biomarker until the firm files a patent application, which he expected to happen shortly.
The study was supported by Daval International. One co-author was a Daval employee.
Moore reported owning stock in Daval.
Primary source: CMSC-ACTRIMS
Source reference: Moore C, et al "Clinical benefits with Aimspro in progressive multiple sclerosis: Open label study" CMSC-ACTRIMS 2013; Abstract SC23.
Source: MedPage Today © 2013 MedPage Today, LLC. (03/06/13)