Chrome 2001
.
The Trusted Source InteliHealth Aetna InteliHealth Aetna InteliHealth
Enter Drug Name . Enter Search Term
     
. .
. .
.
Home
Health Commentaries
InteliHealth Dental
Drug Resource Center
Ask the Expert
Interactive Tools

InteliHealth Policies
Site Map
Diseases & Conditions Healthy Lifestyle Your Health Look It Up
Health News Health News
.
Your Health Daily logo

Prognosis Not So Bright For New Breast Disease Drug
February 16, 2001

FRAMINGHAM, Mass. (The Boston Globe) - Becky Joyner was 12 when she felt the first lump in her breast. Before her doctor even performed a biopsy to check for cancer, he found a second lump.

Both turned out to be benign, harmless fibrotic cysts. But as Joyner got older, cysts grew like clusters of grapes inside her breasts. And with them came a constant, nagging pain.

Doctors told her the problem was fairly common, that no one knew what caused it, that there was no good treatment for it. If the pain worsened, they could surgically drain the cysts.

Then, about two years ago, Joyner saw an ad in a Providence newspaper. A small Framingham company, Symbollon Corp., was looking for women with her condition, known as fibrocystic breast disease, or FBD, to test a possible treatment.

"I thought, "This is great. Finally, someone is trying to do something about this disease,"' said Joyner, now 31.

Within a couple of months, Joyner said, her cysts and her pain began to melt away. But when the study ended, so did Joyner's access to the drug. And in the past year, she said, the cysts and the pain have returned.

For Joyner and other women, Symbollon may be their only hope of getting a drug approved to treat their disease. To the best of Joyner's knowledge - and Symbollon's - no one else is working on a treatment for FBD. Though the disease is itself considered benign, it is associated with a higher risk of breast cancer.

But Symbollon has just $3 million in cash - roughly $10 million shy of what it estimates it will cost to conduct the final phase of clinical testing that federal regulators require.

And if the four-person company can't raise the money, it won't be able to bring the drug to market.

Symbollon said the drug, dubbed Iogen, could be a blockbuster (meaning sales would top $1 billion a year). But interesting investors or a large pharmaceutical company in helping to fund the rest of the drug's development has been an uphill battle.

The problem, said Paul Desjourdy, the company's president, is the difficulty of sizing up the market for the disease. Large pharmaceutical companies generally use sales of existing drugs as a yardstick.

But with fibrocystic breast disease, there is no yardstick. The only available treatments are pain killers and growth hormones, which doctors will not prescribe for long stretches of time. And many doctors don't offer the treatments because the side effects can be worse than the disease.

Since people aren't being treated, Desjourdy said, the number of potential patients seems low. But by all accounts, the disease is common among women of childbearing age. Estimates vary from 25 million to 40 million women in the United States.

Of those, many have relatively mild symptoms, experiencing little or no pain. But studies suggest that at least 3 million to 5 million women with the disease nationwide suffer from moderate to severe pain. And doctors estimate more than half of mammograms are performed because of FBD.

Given the results of the clinical trials it has completed, Symbollon believes Iogen could be taken over a lifetime with minimal side effects, sparing women the pain and frequent mammograms and biopsies that come with having the disease.

The company began developing the drug after its chairman, Jack Kessler, heard about two studies that suggested iodine rids women suffering from FBD of symptoms. Two unrelated studies, one in Canada and one in Russia, involving nearly 1,500 women, showed iodine reduced the number of cysts and the level of pain.

But the doctors' attempts to interest pharmaceutical companies in developing a drug with iodine met with little success. One small company tried but failed to find a way to turn iodine into a safe and effective drug.

Kessler, who had developed iodine-based technologies for other uses, thought he might have a solution.

Iogen contains no iodine, but when it is broken down by the body, it becomes molecular iodine. And unlike the iodine found in foods, which is toxic to the thyroid in large quantities, Iogen seems to deliver large doses of pure iodine without dangerous side effects.

Kessler said Iogen may ultimately prove useful in preventing or treating other diseases, including endometriosis, ovarian cysts and breast cancer. But for the time being, the company is concentrating its efforts and limited resources on getting the drug approved.

With the money it has, the company can begin planning a clinical trial and perhaps even fund the start of one. Kessler and Desjourdy said they plan to meet with the Food and Drug Administration in the spring to get advice on how to structure the trial.

They remain optimistic about raising the money - sooner or later. But with the company's stock trading at less than $2 a share and no source of revenue, its future - and the drug's - depends on their ability to woo investors or a large pharmaceutical company.

"I really hope that they are able to come up with the funding they need," Joyner said. "I'm grateful to them that they have pursued it, because nobody else has. And it's a shame that you have to campaign like this for something that's for the public good."

But if campaigning is what it takes, Joyner is willing to do her part. She and a small group of other women (some were part of the clinical trial for Iogen, and some who were not) appear in a video and other materials that Symbollon hopes will garner publicity and investor interest. They also agreed to talk to reporters about their experiences.

Joyner has had several ultrasounds, dozens of mammograms and countless breast exams. She's refused to undergo biopsies since the one she had as a 12-year-old. She decided one surgery and one scar were traumatic enough.

She said she's learned to live with the pain and constant monitoring. But she is adamant about one thing: FBD is a disease that warrants attention.

"My thinking was, "Let's get the word out; let's get something in the news and in the papers,"' Joyner said. "I'm on a personal mission. Whatever I can do, I'll do it. Because it's suffering for nothing. It's a lot of unnecessary pain."

Judy Bridgewater said she was thrilled to hear Symbollon was working on a drug for FBD. She participated in the Canadian study in the late 1980s and has been hoping ever since that a drug company would get a drug approved.

For years, she kept tabs on the North Carolina company's efforts, only to learn that they had failed. When she found out about Symbollon, she said, she called the company immediately.

"It's been a really a frustrating thing," Bridgewater, 60, said. "No one gets excited about it unless they've had it, because it's not life-threatening. If talking about it is some small thing I can do for other women, then I feel I have to do it."

Copyright 2001 The Boston Globe. All rights reserved.

.
InteliHealth
. . . .
.
More News
InteliHealth .
.
Top News
General Health
This Week In Health
Addiction
Allergy
Alzheimer's
Asthma
Arthritis
Babies
Breast Cancer
Cancer
Caregiving
Cervical Cancer
Children's Health
Cholesterol
Complementary & Alternative Medicine
Dental / Oral Health
Depression
Diabetes
Ear, Nose And Throat
Eyes
Family Health
Fitness
Headache
Heart Health
HIV / AIDS
Infectious Diseases
Lung Cancer
Medications
Men's Health
Mental Health
Nutrition News
Multiple Sclerosis
Nutrition Guide
Parkinson's
Pregnancy
Prevention
Prostate Cancer
Senior Health
Sexual / Reproductive Health
Sleep
Tobacco Cessation
STDs
Stress Reduction
Stroke
Weight Management
Today In Health History
Women's Health
Workplace Health
.
.
.
.
InteliHealth

   
.
.   HONcode
.
Chrome 2001
Chrome 2001