Thanks, V1, I guess there are always risks--time will tell--still seems if there were something harmful to be passed from cows or goats by way of milk to people, it would be known by now.
Very good news from ISIP. Wish I could buy some:
Thursday May 15 6:01 AM EDT
Company Press Release
Source: Isis Pharmaceuticals Inc.
ARVO Presentations Show Safety and Efficacy of Isis' CMV Retinitis Drug
Patients who have failed all other therapies including cidofovir experience prolonged response and lower retinal detachment rate with fomivirsen (ISIS 2922)
CARLSBAD, Calif., May 15 /PRNewswire/ -- Clinical investigators of Isis Pharmaceuticals' (Nasdaq:ISIP) antisense drug for CMV retinitis today presented data at the Association for Vision Research and Ophthalmology (ARVO) meeting in Ft. Lauderdale, Florida, showing that fomivirsen (ISIS 2922), an antisense inhibitor of CMV replication, was effective in stopping the progression of CMV retinitis in patients whose disease had progressed with other CMV retinitis therapies, including cidofovir, and who had no other viable treatment options. Data also showed that patients receiving repeated intravitreal fomivirsen injections experienced a lower retinal detachment rate than what would be expected in a patient population with advanced CMV retinitis.
These and other data presented confirm the efficacy of fomivirsen in patients with advanced CMV retinitis many of whom experienced prolonged progression-free periods. Some of these patients have remained on fomivirsen for as long as over 600 days. Data presented also confirm that the drug's safety profile is attractive, characterized by no systemic toxicities.
Data presented at ARVO derive from an ongoing, multi-center, open-label study of fomivirsen in patients with advanced CMV retinitis who had previously failed other CMV retinitis therapies. Fomivirsen is an antisense compound being developed by Isis as a treatment for CMV retinitis in AIDS patients. It is currently in randomized, controlled pivotal Phase III clinical trials in patients with advanced disease who have failed other CMV retinitis therapies as well as in newly-diagnosed CMV retinitis patients. These trials are evaluating fomivirsen both as monotherapy and in combination with oral ganciclovir and are being conducted in the U.S. and internationally. The Phase III trials are anticipated to be completed later in 1997.
Patients with CMV Retinitis Refractory to Cidofovir Treated with Fomivirsen In a poster presentation entitled, ``Case Studies of Intravitreal
Fomivirsen Sodium for CMV Retinitis Unresponsive to Cidofovir," data were
presented on 11 patients (13 eyes) treated with the 150 microgram and the 330
microgram dose of fomivirsen. These patients had previously been treated
with ganciclovir, foscarnet, intravenous cidofovir or intravitreal cidofovir
(3 patients). All fomivirsen treated eyes showed a decrease in CMV retinitis
activity and only 5 eyes (4 patients) had CMV retinitis progression during
observation. Five patients died, 3 with their CMV retinitis under control at
the time of death.
The median time of fomivirsen benefit for these patients was 125 days (11 patients, 13 eyes; range 15-274 days). The data showed that in this heavily pretreated group of patients who had active, uncontrolled CMV retinitis despite treatment with cidofovir, fomivirsen decreased CMV retinitis activity in 69% of treated eyes (9 of 13 eyes) and controlled progression in 62% of the treated eyes (8 of 13 eyes), some for considerable periods of time.
Fomivirsen is a potent antisense inhibitor of CMV replication. It inhibits CMV strains that are known to be resistant to ganciclovir, foscarnet and cidofovir that share a similar mechanism of action, e.g., inhibition of CMV replication by binding viral DNA polymerase.
The authors on this poster were S. Mansour, Santa Clara Valley Medical; B. Kuppermann, University of California, Irvine; M. Lambert, Baylor College of Medicine; J. Duker, Tufts University; and R. Lieberman, Vitreoretinal Consultants, NYC.
Low Retinal Detachment Rate in Patients Treated with Fomivirsen
In a poster presentation entitled, ``Relative Risk Assessment of Retinal Detachment or Endophthalmitis with Intravitreal Injections of Eyes with CMV Retinitis,'' data were presented on patients with active CMV retinitis that could not be controlled despite repeated courses of ganciclovir, foscarnet or cidofovir. One hundred ninety-nine (199) eyes were injected with the 330 microgram dose of fomivirsen, for a total of 1817 injections for a maximum of 477 days. A 9% incidence of retinal detachment was reported in these patients (18 retinal detachments in 199 eyes). It is estimated that the lifetime risk of retinal detachment among treated CMV retinitis patients can be as high as 40-50%.
These data showed that repeated intravitreal injections of fomivirsen for treatment of CMV retinitis produced a very low and acceptable risk of retinal detachment and a minimal risk of endophthalmitis in a patient population at high risk for both events.
The authors on this poster were D. Boyer, Retina-Vitreous Associates Medical Group, CA; H. Cantrill, Vitreo-Retinal Surgery, MN; G. Jaffe, Duke University Medical Center; B. Kuppermann, University of California, Irvine; J. Lalezari, University, San Francisco; M. Lambert, Baylor College of Medicine; R. Lieberman, Vitreoretinal Consultants, NYC; S. Park, University of Texas at Dallas; B. Terry, Community Eye Medical, CA.
Confirmation of Safety and Efficacy of Fomivirsen in Patients with Refractory CMV Retinitis In a podium presentation by Ronni Lieberman, M.D., entitled, ``Antisense
Oligonucleotide (Fomivirsen Sodium) Treatment of CMV Retinitis Unresponsible
to Other Antiviral Therapies," data on patients that were treated with the 330
microgram dose of fomivirsen showed that fomivirsen produced prolonged
progression-free periods in patients with highly refractory CMV retinitis. Of
71 eyes that received the full induction doses (once per week for 3 weeks) and
had a follow-up two weeks later (day 28), the median progression-free survival
was 70 days, and the range was 26-601 days.
Updated safety data on ocular adverse events were also presented on 190 eyes treated with the 330 microgram dose and on 55 eyes treated with the 150 microgram dose. The data confirmed that patients on fomivirsen experience acceptably low levels of ocular adverse events (transient increases in intraocular pressure, inflammation, vitritis, retinal detachment, peripheral vision loss) and no systemic side effects due to fomivirsen. These events are in most instances clinically manageable or tolerable and demonstrate fomivirsen's profile as an effective, safe and well-tolerated treatment for CMV retinitis.
This press release contains forward-looking statements concerning the therapeutic potential of fomivirsen, a compound in development as a treatment for CMV retinitis in AIDS patients. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Actual results could differ materially from those projected in this release. As a result, the reader is cautioned not to rely on these forward-looking statements. These and other risks are described in additional detail in Isis' Annual Report on Form 10-K for the year ended December 31, 1996 and in the Company's most recent quarterly report on Form 10-Q, which are on file with the U.S. Securities Exchange Commission, copies of which are available from the company.
Isis Pharmaceuticals, based in northern San Diego County, is engaged in the discovery and development of novel human therapeutic compounds. Isis has five compounds in human clinical trials: ISIS 2922, to treat CMV-induced retinitis in AIDS patients, is in Phase III clinical trials; ISIS 2302, an inhibitor of ICAM-1, is in a pivotal quality trial for Crohn's disease and Phase II clinical trials for renal transplant rejection, rheumatoid arthritis, psoriasis, and ulcerative colitis; ISIS 3521/CGP 64128A and ISIS 5132/CGP69846A, both anticancer compounds, are in Phase I clinical trials; and ISIS 5320, a combinatorially-derived anti-HIV compound, is in Phase I clinical trials. The company also has several additional compounds in preclinical development. Isis' broad medicinal chemistry and biology research programs support efforts in both antisense and combinatorial drug discovery.
Also Joe Kernan on CNBC made some very bullish comments on ISIP.
While the market for CMV retinitis is not too large, this is a big validation for ISIP's antisense technology. |
