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Brain cancer drug holds huge potential

Posted on: 07/04/2002

Source: Denver Post

Brain cancer drug holds huge potential

Allos of Westminster in last phase of testing

By Marsha Austin
Denver Post Business Writer

Thursday, July 04, 2002 - By the end of next year, terminal brain cancer patients could be living months longer thanks to RSR-13, a drug developed by Westminster-based Allos Therapeutics.

After eight years of research and development, Allos is in the last stage - Phase III - of testing on RSR-13 and could begin distributing the drug worldwide as soon as late 2003.

RSR-13 is designed to boost the effectiveness of radiation therapy in cancer patients by infusing tumor cells with oxygen. Many of the most serious brain tumors don't respond to radiation therapy because there is no oxygen flow to the cells in the tumor's core.

RSR-13's oxygen infusing properties drew international media attention during last year's Giro de Italia bicycle race when athletes allegedly used black market doses of the drug to increase oxygen levels in their blood. The allegations were never proven.

Metastatic brain cancer is so swift and devastating a disease that it killed the only two patients who enrolled in Allos' latest clinical trial of RSR-13 at the University of Colorado Cancer Center - before they could get the experimental drug.

"You are talking about people in a very advanced stage of their disease," said Dr. Brian Kavanagh, an oncologist and researcher at CU Cancer Center.

More than 500 other brain cancer patients in 11 countries around the world will receive RSR-13 this year as part of the Phase III trials. The University of Colorado brain cancer trial is still open to interested patients.

If RSR-13 can prolong the lives of brain cancer patients in Phase III trials by at least 35 percent, Allos can submit a new drug application to the FDA.

The goal is to add months, perhaps years, to cancer patients' lives and improve the quality of life for terminal patients whose cancer has spread throughout the body, said Kavanagh.

Metastatic brain tumors are caused by clusters of cancer cells that have travelled to the brain from other parts of the body, most often the breast or lung. Anywhere from 20 to 40 percent of cancer patients develop brain metastases, according to the North American Brain Cancer Coalition.

Most patients with metastatic brain cancer die within four to six months of diagnosis, said Kavanagh, who did early research on RSR-13 while at Virginia Commonwealth University.

The FDA requires drug developers to put their products through three phases of rigorous testing, first in animals, then in humans. Depending on funding and success rate, the process can take more than 10 years. Many biotech companies run out of cash or watch lead drugs fail before the end of the process. Some turn to partnerships with large pharmaceutical companies to keep their research going.

The FDA has already granted Allos fast-track status for RSR-13, allowing the biotech company to bring its drug to market without as much testing as is normally required. The FDA reserves fast-track designation for drugs that target diseases for which there is no existing treatment.

Allos has managed to weather volatile public markets alone and amazingly well compared to other biotechs its size. The company launched a $99 million IPO in March 2000, just before the biotech industry took one of its biggest Wall Street dives, and has managed to stash away two years of cash reserves.

Allos has not sold the rights to market its drug.

"Most companies are not set up at this stage of the game to do that in a big way," said Allos chief executive officer Michael Hart. "In the past, partnerships were done to validate the technology of the smaller company.

"It kind of gave investors a Linus blanket."

Allos is also testing RSR-13 in lung and cervical cancer patients. Denver Health is enrolling patients in early-stage cervical cancer trials.

If RSR-13 were sold under both a brain cancer and lung cancer label, the drug could generate upwards of $600 million a year, said Hart.

Analysts have pinned a strong buy rating on Allos stock, which has more than doubled in price during the last year, jumping from $4.25 on June 30, 2001, to $9.24 on June 28, 2002.

C.E. Unterberg, Towbin likes the stock because its analysts believe the company will sign a marketing agreement with a large European pharmaceutical company to distribute RSR-13 worldwide. In a June 17 report, C.E. Unterberg also liked the fact that Allos will have patients lined up for its clinical trials earlier than expected.

RSR-13 technology was originally discovered by Dr. Donald Abraham, a professor of medicinal chemistry at Virginia Commonwealth University.

Originally known as Hemotech Sciences, Allos moved to Colorado in 1994 and with seed money from Johnson & Johnson and other private investors, began the long process of bringing RSR-13 to market.
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