Boards
News
Market Data
Markets
Discover
Discover
AI Subscribe Login/Register account icon
S&P 500
6,591.90
(
0.54%
)
US TECH 100
23,278.40
(
-1.00%
)
Dow Jones
46,429.49
(
0.00%
)
Brent Oil
102.53
(
3.80%
)
Bitcoin
69,288.02
(
-2.83%
)
News Focus
News Focus
Post# of 257288
Next 10
Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

DewDiligence

Send PM Follow Ignore
Followers 843
Posts 122810
Boards Moderated 10
Alias Born 09/05/2002

DewDiligence

Member Level

Re: None

Saturday, 02/07/2004 3:57:18 PM

Saturday, February 07, 2004 3:57:18 PM

Post# of 257288
Squalamine article in Ophthalmology Management:

[I had not heard of the Ophthalmology Management publication until now. Is anyone here familiar with it? Thanks to tdwatson on yahoo for this find. Annotations below in italics by Dew]

http://www.ophthalmologymanagement.com/archive_results.asp?article=85981&tmh=1

>>
Issue: January 2004

Genaera's AMD Treatment Creates a Stir

Company Gets Lots of Attention from Early Results.

Anyone even remotely familiar with the pharmaceutical industry will easily recognize the names Genentech, Pfizer, Novartis and Alcon. But until recently, hardly anyone could tell you much about a company named Genaera.

Those who did know about Genaera could tell you that the drug development company, based in Plymouth Meeting, Pa., began in 1987 as Magainin Pharmaceuticals and has gone through more than $180 million in the past 16 years without one FDA approval to show for its efforts.

Initially, the company focused its research on a class of microbial peptides called magainins, which had shown an ability to defend against invading bacteria. More recently, the company has been best known for its research efforts with squalamine, a patented, synthesized aminosterol with antiangiogenic properties, originally found in its natural state in the livers of certain types of sharks.

Because antiangiogenic agents inhibit the growth of new blood vessels -- blood vessels that could nourish tumors -- Magainin, and then Genaera, essentially saw squalamine as a potential treatment for many types of cancers. The company conducted several Phase I/II clinical trials employing squalamine as a cancer-fighting agent.

And though Genaera's chief operating officer Kenneth Holroyd, M.D., says that the company is still pursuing squalamine as a treatment for prostate and lung cancer, Genaera is now primarily focusing on squalamine as a potential treatment for wet AMD. This puts little Genaera squarely in a race against the deep pockets of Genentech/Novartis, Alcon and Pfizer/Eyetech to develop a new and effective next-generation drug to combat wet AMD.

Genaera recently created a stir in the ophthalmic community, and triggered a sharp jump in its stock, by releasing results of an uncontrolled clinical trial of squalamine conducted in Mexico by Hugo Quiroz-Mercado, M.D., in consultation with Charles Garcia, M.D., professor of ophthalmology at the University of Texas at Houston, and Gholam Peyman, M.D., professor of ophthalmology at Tulane University in New Orleans.

In the trial, 40 patients were given four weekly doses of squalamine, administered intravenously, with no further maintenance therapy. The 4-month results reported were highly positive, with all patients having improved or preserved vision and 10 patients improving by 3 or more lines on an EDTRS chart. Patients' angiograms are being sent to reading centers for a confirmatory study. [This statement, presumably based on Dr. Levitt’s remarks back in October, is no longer accurate.]

"These data are very preliminary. They need to do a lot more," says Jerry Chader, Ph.D., M.D., chief scientific officer for The Foundation Fighting Blindness. "But the data look good."

"We are planning to begin a Phase II controlled trial in the second quarter of 2004," says Dr. Holroyd. "We'd like to have a partner, but we can do the Phase II study alone."

Genaera has emphasized that squalamine is delivered by patient-friendly intravenous injection, which can treat both eyes at once, while other wet AMD treatments under development are administered directly into or adjacent to the eyeball.

Though experts such as William Li, M.D., president and medical director of The Angiogenesis Foundation, point out that intravenous squalamine has been well-tolerated in cancer trials, questions have been raised by some researchers about intravenous delivery of an antiangiogenic drug for an eye disease. Could it cause more undesirable systemic side effects than an antiangiogenic agent delivered directly to the eye, especially in an elderly patient population?

"These questions are under investigation," explained Dr. Peyman. "However, if a drug is given systemically for a limited time and is effective, it would be desirable and acceptable to the patients." [Moreover, the dose that will be used in AMD, 25mg/m2, is only one-fourth to one-eighth of the dose of that was well tolerated in cancer trials.]

"This (systemic side effects) is a concern for all of the compounds, not just ours," says Dr. Holroyd. "This question will be answered over time, with additional trials."

Skeptics have pointed to the fact that the Biotechnology Value Fund (BVF) provided Genaera with several million dollars of new funding in May in return for about a 10.5% equity stake in the company, but sharply reduced its holdings of Genaera shortly after the positive trial results had been released.

While Magainin/Genaera's track record of the past 16 years invites skeptics, Dr. Holroyd is optimistic.

"We're not the only company that's been in this type of position," he notes. "Eyetech is a small company that got a partnership with Pfizer. Regeneron is another small biotech that just did a $500 million partnership deal with Aventis. It took Scios 21 years to get its first drug approved, and they just got bought out by Johnson & Johnson for $2.4 billion."
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

Public Reply Private Reply New Post
Keep Last Read
Replies (1) Keep Last Read Next 10 Report Keyboard Shortcuts
Replies (1) Next 10 Prev Next

Discover What Traders Are Watching

Explore small cap ideas before they hit the headlines.

Join Today