Phase I trials for a drug for Celiac

[cruelshoes]

Thought I'd get to this one before Al did.

http://www.mddailyrecord.com/pub/5_403_thursday/businessnews/173112-1.html

October 27, 2005

Tiny drug firm lifted in trials, bureaucracy
By KAREN BUCKELEW
Daily Record Business Writer


Fledgling Baltimore biotech Alba Therapeutics Inc. seems on the fast track now, as its lead drug candidate has just completed a successful Phase I trial and, at the same time, it has been awarded Fast Track status by the Food and Drug Administration.

The drug, AT-1001, targets celiac disease, an autoimmune disorder.

The four-week trial, which finished this month, marked the first human testing of the drug, this time in healthy subjects. Phase I-B and I-C trials are planned for this year and early next year, with a Phase II trial — this time, in subjects suffering from celiac disease — expected in the spring.

“We’re delighted,” said Dr. Blake Paterson, the company’s president and CEO. “We’re full speed ahead. I would assume it really makes the investors feel good.”

Alba, a 1-year-old spinoff from the University of Maryland School of Medicine and current tenant of the Emerging Technology Centers incubator in Canton, earlier this year closed on a $30 million first round of financing.

It is set to move into the University of Maryland, Baltimore’s new West Side BioPark early next year.

Celiac disease is an autoimmune disorder that often is misdiagnosed, as its symptoms mirror those of various other conditions, including irritable bowel syndrome.

It once was believed to be a food allergy, as its symptoms are triggered by the ingestion of gluten, a mixture of proteins found commonly in food. The only current treatment is eliminating gluten from the diet — a difficult proposition, as gluten is hidden in numerous foods.

Untreated, celiac disease can lead to gastrointestinal lymphoma and osteoporosis, among other conditions.

The National Institutes of Health last year convened experts from around the country to reach a consensus on the disease, its prevalence and how best to spread the word about it.

The consensus is the disease most likely affects 3 million Americans, or 0.5 percent to 1 percent of the United States population. But only about 100,000 cases were diagnosed at that point, said Paterson.

Alba’s technology involves the use of zonulin, an endogenous signaling protein, to prevent leakage of gluten’s damaging proteins into the celiac patient’s system. It would allow patients to continue eating gluten while blocking its harmful effects.

The gluten-free diet “is a tremendous change of lifestyle,” said Dr. Alessio Fasano, a professor of pediatrics, medicine and physiology at the University of Maryland, who discovered zonulin. Fasano co-founded Alba and holds ownership interest, but no longer has a position at the company.

He is in talks to return to the company as head of its scientific advisory board, Fasano added.

“Exciting is an understatement,” he said of the firm’s recent developments. “I’ve been waiting for this moment for a long time.”

The Fast Track designation will allow the company input from the FDA as it develops its drugs — usually, said Paterson, “they are loathe to do so.”

It also allows the firm to submit its new drug applications in smaller sections rather than all at once, and gives the company a chance at accelerated approval of the drug.

But Paterson said he is not resting on his laurels just yet.

“I’ll feel good when the product is safely in the hands of the patients,” he said.
_________________
-Colleen
Dx 8/05 via bloodwork/biopsy
10-YO son Dx 11/05 via bloodwork/biopsy
Daughters (12 and 2) have neg. bloodwork

A woman is like a tea bag-you never know how strong she is until she gets in hot water. - Eleanor Roosevelt

[paw]

Very interesting, thanks for posting.

[aklap]

Hehehe I saw this on 9/26/05 and not had a chance to post it! Thanks!!!

Phase 1 trials are used just to test the drug safety. My friend Cara found this link...it shows the phases of product developement.

http://www.allp.com/drug_dev.htm
_________________
Al

“We cannot all do great things, but we can do small things with great love.” Mother Teresa