Doug,
Remember that the cross sectional area increase is greater than the increase in diameter - thus even a 10% increase in diameter produces a more than 20% increase in area, and a 50% increase more than doubles the cross-sectional area.
I agree that there is still a long way to go here, but this is the sort of product that could easily catch the ENMD/GERN-public's imagination (to a lesser extent, of course).
I can't understand why the stock continues to languish. Maybe there's been some VC selling - it's hard to know for sure now, as their last public offering pushed most VC holdings below the 5% reporting threshold.
Here's the latest roto-rooter releases:
Pharmacyclics' ANTRIN(TM) Photoangioplasty Presented as a 'Hot Topic' Paper at RSNA
PR Newswire - November 30, 1998 16:39
Updated Interim Phase I Results Presented
SUNNYVALE, Calif., Nov. 30 /PRNewswire/ -- Pharmacyclics, Inc. (Nasdaq: PCYC) today announced that updated interim results from its phase I study with ANTRIN(TM) photoangioplasty for patients with atherosclerotic peripheral arterial disease were reported at the meeting of the Radiological Society of North America (RSNA) in Chicago. The presentation was selected for delivery as a "Hot Topic" in the cardiovascular session. The RSNA selects papers for presentation as Hot Topics based on innovation and importance.
Eighteen patients were reported on who had been treated at Stanford University Medical Center in the ongoing phase I study. The trial was designed primarily to evaluate the safety of ANTRIN followed by photoangioplasty in patients with severe symptomatic arterial insufficiency involving the major arteries of the lower extremities. Successive groups of patients received a single treatment with increasing doses of ANTRIN followed 24 hours later by photoangioplasty of a critical lesion. Patients were evaluated both for systemic toxicity and local arterial responses by follow-up intravascular ultrasound (IVUS) and angiograms. ANTRIN was given intravenously and light was delivered to the diseased artery through a 0.89mm optical fiber catheter using standard percutaneous endovascular techniques.
The data presented update and confirm the statistical significance of results recently presented at the meeting of the American Heart Association in Dallas on November 9th. Response to treatment, defined as an increase of greater than ten percent in the blood vessel opening (minimal luminal diameter, "MLD"), was particularly evident in patients evaluated with IVUS, where responding patients' MLD increases ranged from ten to seventy-four percent.
The presentation was delivered by Mahmood Razavi, M.D., assistant professor of radiology, a cardiovascular interventional radiologist at Stanford. "We have reached the limits for mechanical treatments of atherosclerosis," stated Dr. Razavi. "Atherolysis of plaque with ANTRIN photoangioplasty is a promising technique, which may have advantages over mechanical methods such as balloon angioplasty."
Various doses of ANTRIN were evaluated and no serious treatment-related adverse reactions or vascular toxicities have been observed. At the higher doses, some patients reported mild and transient tingling sensations in the tips of their fingers, nose or ears, or skin reactions that were thought to be associated with exposure to sunlight.
ANTRIN is a water-soluble photosensitizer that accumulates in atherosclerosis, is cleared rapidly from the blood and is activated by 732nm light, a wavelength that is able to penetrate through blood. This property enables the treatment of atherosclerosis or restenosis without interruption of blood flow. Once localized in the diseased vessel, ANTRIN can be activated by endovascularly-delivered light using an optical fiber inserted into the vessel. In contrast to mechanical procedures such as balloon angioplasty, ANTRIN photoangioplasty appears to reduce atherosclerosis without damaging the endothelium and without damaging the vessel wall, both important factors leading to restenosis. Long segments of diseased vessels may be treated, which is a potential advantage over existing angioplasty techniques that are limited to the treatment of relatively short segments.
Atherosclerosis results from the accumulation of cholesterol, macrophages and smooth muscle cells in the walls of blood vessels. This often results in narrowing of the lumen and reduction of blood flow. In the coronary arteries (arteries that supply the heart with blood), atherosclerosis can result in angina or heart attacks. In the cerebrovascular circulation (arteries supplying blood to the brain) atherosclerosis may result in stroke, and in the peripheral circulation it may result in ischemia leading to decreased function and ultimately loss of limbs.
Currently, atherosclerosis is treated with medical therapy, surgery or endovascular procedures such as balloon angioplasty. There are approximately 600,000 coronary angioplasty procedures performed annually in the U.S. and another 150,000 such procedures performed in the lower extremities. Angioplasty is complicated by the development of restenosis, or the renarrowing of blood vessels, in a significant number of patients which has led to the widespread use of stents. Although stents are effective in opening the vessel, this procedure has only partially addressed the problem.
IVUS is a procedure used to evaluate the inside of arteries and is performed by inserting an ultrasound transducer within the lumen of the blood vessel. Using this diagnostic technique, it is possible to measure the size of the lumen or the degree of obstruction within a vessel. IVUS can also be used to evaluate the characteristics of the blood vessel wall. It is commonly used to assess atherosclerosis and response to therapeutic interventions. Angiograms are performed by injecting X-ray contrast media into blood vessels and are also used to evaluate abnormalities of blood vessels. Generally, angiograms are less sensitive and less quantitative than IVUS.
Pharmacyclics is a pharmaceutical company developing energy-potentiating drugs to improve radiation therapy and chemotherapy of cancer, and to enable or improve the photodynamic therapy of certain cancers, atherosclerotic cardiovascular disease and diseases of the retina. The company's products are ring-shaped small molecules, called "texaphyrins," which are patented agents derived from Pharmacyclics' versatile technology platform for designing and synthesizing energy-potentiating drugs. These texaphyrins localize in cancer cells and atherosclerotic plaque, where they can be activated by forms of energy, including X-ray, chemical and light, to eliminate diseased tissue.
The statements made in this press release may contain certain forward-looking statements that involve a number of risks and uncertainties. Actual events or results may differ from the company's expectations. In addition to the matters described in this release, future actions by the U.S. Food and Drug Administration and other domestic and foreign regulatory agencies, the initiation, timing and results of pending or future clinical trials, as well as risk factors listed from time to time in the company's reports as filed with the U.S. Securities and Exchange Commission, including but not limited to, its reports on Forms 10-Q and 10-K, may affect the actual results achieved by the company.
NOTE: PHARMACYCLICS(R), the "pentadentate" logo(R) and ANTRIN(TM) are trademarks of Pharmacyclics, Inc.
SOURCE Pharmacyclics, Inc.
/CONTACT: Leiv Lea of Pharmacyclics, Inc., 408-774-0330; or Angela M.
Bitting of Russell-Welsh, Inc., 650-312-0700, ext. 15, for Pharmacyclics; or
Mike Goodkind of Stanford University, 650-725-5376, or 650-723-6911/
And here's the Reuter's version:
Tuesday December 1 4:05 PM ET
Study: Laser Plus Drug Equals Clear Arteries
CHICAGO (Reuters) - A drug activated by laser light unblocked fat-clogged
arteries in some patients without the scarring that can result in arteries
becoming blocked again, a researcher said Tuesday.
Ultrasound exams showed the drug worked on 11 of 14 patients participating
in an early trial, Mahmood Razavi, a radiologist in the division of
cardiology at Stanford University Medical Center, told Reuters.
Blood vessel openings expanded by between 10 percent and 74 percent in those
patients whose arteries were partially blocked by plaques.
Plaques are raised areas inside the artery where fatty deposits have built
up. The result is atherosclerosis, which is responsible for more deaths in
the United States than any other single condition.
''Once activated, the drug is toxic to the plaque cells,'' Razavi said. ''In
animal studies, it completely melted away the plaque.''
Razavi presented the results of Phase I trails on the drug, called lutetium
texaphyrin, at the annual meeting of the Radiological Society of North
America. Drug manufacturer Pharmacyclics Inc. (Nasdaq:PCYC - news) of
Sunnyvale, California, paid for testing on the drug, to be marketed under
the brand name Antrin.
Another form of the same drug was proving effective in killing cancer cells
and is being tested on patients suffering from breast and brain cancers and
melanoma, he said.
The cardiovascular form of the drug is injected into the patient's
circulatory system and doctors wait 24 hours to allow it to accumulate at
the site of arterial clogs.
A micro-catheter is then threaded to the area, and a low-power red laser
activates the light-sensitive drug, which does not harm arterial cells.
The drug is drawn to receptors found on immune system cells sent by the body
to do battle with the blockage. The cancer- fighting form of the drug
similarly targets areas where cancer cells are numerous.
Among the most common existing treatments for clogged arteries is
angioplasty, where a tiny balloon is threaded to the blockage where it is
inflated and used to break through the clog and reopen the passage.
But angioplasties -- 750,000 of which are performed each year in the United
States -- often damage the arterial lining, causing scar tissue to form and
re-blocking the artery in as little as six months, Razavi said.
''With the drug, since we are not doing any injury to the artery, there's no
re-clogging of the artery,'' he said.
Peter |
