Trial Failure Halts Testing On Psoriasis Drug

CombinatoRx has decided to discontinue development of CRx-140, its oral product candidate for the treatment of psoriasis, after the compound failed to reach its primary and secondary endpoints in a phase II trial.
The trial, which enrolled 103 patients in the US and Canada, studied the effect of a 12 week treatment of CRx-140 compared to low-dose cyclosporine. However, the drug failed to show a statistically significant greater reduction in symptoms of severe psoriasis than cyclosporine.
In the trial, psoriasis symptoms were measured as scores on the physician global assessment (PGA) and psoriasis area severity index (PASI) scales.
"The preliminary results from this first phase IIa trial of CRx-140 are clearly disappointing," said Dr Jan Lessem, chief medical officer of CombinatoRx. "Both CRx-140 and low dose cyclosporine decreased PGA and PASI, but the results of the two arms were not statistically different, nor was the magnitude of the effects sufficient to warrant further development."

Treating Psoriasis With Lasers

Doctors have begun introducing an instrument known as the XTRAC laser to treat psoriasis.
Statistically, about four and a half million Americans suffer from psoriasis.
Psoriasis is a skin condition that is difficult to diagnose and has no cure. The skin troubles associated with psoriasis are caused by abnormal white blood cells. The cells settle into the skin, causing it to become irritated and inflamed.
Experts said the XTRAC laser targets those cells.
Bethesda Dermatologist Dr. Ronald Prussick said the laser works best on people with relatively small, isolated patches that don't respond to other treatments.
"The way it works is it helps get those abnormal white blood cells that are in the skin, back out of the skin back into the blood stream," said Prussick. "It works very well for the scalp, and I also use it for people who have the psoriasis on the hands and the feet, because traditionally, those areas are difficult to treat."
Each laser treatment lasts just a few minutes. But doctors said it usually takes several sessions over a period of weeks to see a difference.
Elizabeth Thornton has been suffering with psoriasis on her hands and feet for two years. She said that at times, it's been so severe she could barely walk and trying to find a treatment that works has been a struggle.
"I've had 10 million creams. I have any cream you can name, I've had so many of them," said Thornton.
The laser has been able to do for Elizabeth what the creams and medications couldn't.
"It cleared up my feet, completely cleared, my hands cleared," said Thornton.
Doctors stress that the laser is not a cure for psoriasis and it only provides temporary relief. They also said the laser won't work for everyone and should be used by people who haven't responded to other treatments.
The cost of the laser treatments is usually covered by health insurance.

New Options In Treating Psoriasis May Not Help Everyone

It’s a new era for patients covered in the itchy, scaly skin disease psoriasis. After years with few good treatments, doctors finally have a handful of therapies that promise to help control the incurable condition with fewer bad side effects.
What changed? Scientists learned that psoriasis isn’t just a skin-deep disorder but a dysfunction of the immune system, so the new therapies target the real culprit.
“Five to six years ago, I was telling my patients it was the wasteland,” says Dr. Craig Leonardi of St. Louis University Medical School, who participated in studies of the new treatments. “Now there’s this huge explosion of amazing drugs coming forward.
The new options don’t help everyone, cautions Dr. Michael Tharp, dermatology chief at Chicago’s Rush University Medical Center. And they’re very expensive, costing $10,000 a year or more.
But, “it’s a great first step,” Tharp says. “Now we’ve got very directed molecules and know where they work and how they work. ... I hope it is just the beginning.”
Two unique psoriasis shots, Amevive and Raptiva, recently won Food and Drug Administration approval. Two drugs already sold to treat other conditions — Enbrel and Remicade — are used against psoriasis, too. A list of other potential treatments is under study.

TolerRx Gets Orphan Drug Designation

TolerRx, Inc. today announcedthat its lead product, TRX4, has received orphan drug designation by the U.S.Food and Drug Administration (FDA) for the treatment of new-onset Type 1diabetes mellitus. TolerRx is currently conducting a clinical study of TRX4 inthe U.S. in subjects with Type 1 diabetes. Orphan drug designation would entitle TolerRx to exclusive TRX4 marketingrights in the United States for seven years should TolerRx be the firstcompany to receive marketing approval for this type of therapeutic drugproduct. In addition, the designation would allow TolerRx to apply forresearch funding, tax credits for certain research expenses, and a waiver fromthe FDA application user fee required by the Prescription Drug User Fee Act(PDUFA). "We are pleased to have received this orphan drug designation for TRX4 inthe treatment of new-onset Type 1 diabetes," said Douglas J. Ringler, ChiefExecutive Officer of TolerRx. "This designation is one in a number of plannedstrategic initiatives that will provide us with financial and regulatorybenefits and market exclusivity." In a study of subjects with new-onset Type 1 diabetes published in theJune 23, 2005 edition of the New England Journal of Medicine, TRX4 (ChAglyCD3)was shown to preserve the function of insulin-producing beta cells in thepancreas and reduce the amount of administered insulin needed to control bloodglucose levels for at least 18 months after a single six day course of TRX4.At the doses used in this study, TRX4 administration was associated withtransient symptoms of flu-like syndrome and transient EBV reactivation.TolerRx recently initiated a clinical trial in the U.S. in subjects with Type1 diabetes designed to optimize and select a TRX4 dosing regimen to be used inlater phase trials. About Type 1 Diabetes Diabetes (medically known as diabetes mellitus) is the name given todisorders in which the body has difficulty regulating its blood glucose, orblood sugar, levels. There are two major types of diabetes: Type 1 and Type 2.Type 1, also called juvenile diabetes or insulin-dependent diabetes, is adisorder of the body's immune system. In Type 1 diabetes, the pancreasproduces little or no insulin as a result of the immune system attacking anddestroying the insulin-producing beta cells in the pancreas. Therefore, Type 1diabetes patients require frequent administration of insulin therapy each dayto control their blood sugar levels. In the United States, approximately 1.3 million people have Type 1diabetes, and each year approximately 30,000 new patients are diagnosed withthe disease, including 13,000 children. About TRX4 TRX4 is a monoclonal antibody that binds to a receptor found on all Tcells called CD3, which is involved in normal T cell signaling. TRX4 isdesigned to block the function of autoreactive T-effector cells that attackthe body's tissues and cause autoimmune disease. Because T-effector cells andT-regulatory cells utilize different signaling pathways for activation, TRX4is expected to suppress autoreactive T cells while promoting T-regulatory cellactivity, resulting in a state of immunological tolerance. In addition to Type1 diabetes, TolerRx is also developing TRX4 for the treatment of psoriasis andis currently enrolling subjects in a U.S. Phase Ib study of subjects withmoderate-to-severe psoriasis.

Treating Psoriasis With Retinoids

These drugs are related to Vitamin A. They normalize the growth of skin cells in psoriasis. A new retinoid, acitretin (Soriatane) was introduced in 1998, replacing etretinate (Tegison). This drug is useful in treating severe forms of psoriasis, such as Erythrodermic and pustular psoriasis that do not respond to other therapies. Retinoids are almost certain to cause birth defects. They cannot be used by pregnant women, women planning to become pregnant, or their male partners. Women who take acitretin must avoid pregnancy for up to 3 years after they stop taking the drug. Women also must not drink alcohol while they are taking acitretin and for 2 months after they stop taking it. Alcohol can cause the drug to change to its chemical cousin, etretinate, in the blood. Etretinate can cause severe birth defects for many years after its use. Other possible side effects of retinoids are dry skin, chapped lips, dryness of the eyes and nasal passages, hair thinning, sun sensitivity, and bone spurs of the long bones or spine. The drugs may also increase blood levels of liver enzymes and triglycerides, a type of fat found in the blood. Reducing the dose of the drug usually reduces these side effects. Another retinoid, isotretinoin (Accutane) is sometimes used to treat psoriasis. It may be helpful for some people, especially if combined with ultraviolet light treatment, but it is generally less effective than acitretin. Isotretinoin is approved by the U.S. Food and Drug Administration to treat severe acne but not to treat psoriasis.

Progress Noted In Psoriasis treatment

Pharmaceutical products developer York Pharma said it has progressed in the development of a new topical treatment for psoriasis. The group said it has selected Carbenoxolone as its lead compound for a new class of drugs termed Vitamin A Metabolic Pathway inhibitors. "To date, in vitro and in vivo study results supporting the use of carbenoxolone in psoriasis have all been positive," said the group. It added that Phase II results further supported carbenoxolone as a new treatment for psoriasis. "York is pleased that these preliminary Phase II data indicate the potential of carbenoxolone for the treatment of this condition, and that the company's dermatology pipeline is continuing to make significant progress," said chief executive Terry Sadler.

Aloe Vera For Psoriasis

Long used to speed the healing of mild burns, it's now study proved to improve symptoms of psoriasis when used three times a day for eight months. Break the leaf of an aloe plant to get the soothing gel or use a lotion that's at least 20% pure aloe vera.