Goat Serum Extract Stops Progressive MS

By John Gever, Deputy Managing Editor, MedPage Today

Published: May 31, 2013
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania


ORLANDO — 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.

Source  http://www.medpagetoday.com/MeetingCoverage/CMSC-ACTRIMS/39495


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