Larry, More good news coming. Today LGND announces that Panretin also induced complete remissions in Acute Promyelocytic Leukemia (APL)patients. This is very significant because the Kaposi Sarcoma data was on topical treatment with Panretin. The data presented today is on oral treatment. Currently, Roche has an oral treatment (Vessanoid) for APL, but treatment induces the body to metabolize the drug, thereby limiting long term use. Panretin is more stable. Maybe CNBC will do another story tomorrow. It's just a Phase I/II study, but it looks like another potential HALT of Phase III trial which is on-going (and I believe is slated for conclusion next year (I don't know if interim look is included in protocol).
Here's the press release:
Investigators Present Final Phase I/IIa Data on Oral Panretin(TM) In Acute
Promyelocytic Leukemia at International Meeting in Stockholm
SAN DIEGO, Sept. 1 /PRNewswire/ -- Allergan Ligand Retinoid Therapeutics
Inc. (ALRT) (Nasdaq: ALRI) announced that researchers reported today at the
International Society of Hematology Conference in Stockholm, Sweden that both
newly diagnosed and relapsed patients with acute promyelocytic leukemia (APL)
who were treated with Oral Panretin(TM)(9-cis retinoic acid) attained complete
durable remissions.
The final results of the APL Phase I/IIa trial, conducted at Memorial
Sloan-Kettering Cancer Center (MSKCC), included 18 patients who were treated
with a once-daily dose of Oral Panretin. Seventeen of the 18 bad the
molecular marker, PML/RAR(alpha), diagnostic of APL, and one had an unusual
molecular marker and leukemia cells with the appearance of APL.
Of the 18 patients, five were newly diagnosed and 13 were relapsed from
previous therapy. Four of five newly diagnosed patients attained complete
remission. (One of the five newly diagnosed patients died early in the study
due to common complications of this type of leukemia.) Four of 12 (33 percent)
relapsed patients with the PML/RAR(alpha) molecular marker also experienced
complete remission, Three of these relapsed patients who attained complete
remission were previously treated with all-trans retinoic acid (ATRA).
Oral Panretin is a compound of ALRT. This trial was conducted by Ligand
Pharmaceuticals Inc. (Nasdaq: LGND) in the U.S. on behalf of ALRT.
"Although the use of all-trans retinoic acid for APL patient for induction
therapy has significantly increased overall survival compared to patients who
are treated with chemotherapy alone, ATRA's use is limited by the rapid
development of retinoid resistance," according to Dr. Raymond P. Warrell, Jr.,
principal investigator at MSKCC. "Retinoid resistance is clinically
associated with a progressive decline of the levels of retinoid drug in blood
plasma levels because of autoinduced cataboli. This study shows more stable
plasma concentrations of Oral Panretin at lower doses than with ATRA," Dr.
Warrell said.
STUDY DESIGN & METHODOLOGY
The objectives of the APL Phase I/IIa study were to evaluate the safety
and efficacy of Oral Panretin in APL patients. The trial included 18 patients
who were treated with a once-daily dose of Oral Panretin, ranging from 30 -
230 mg per square meter of body surface area (mg/m(2)) until complete
remission. Of the 18 patients, five were newly diagnosed and 13 were relapsed
from previous therapy. Seventeen of the 18 had the molecular marker,
PML/RAR(alpha), diagnostic of APL and one had an unusual molecular marker and
leukemia cells with the appearance of APL.
RESULTS
Four of five newly diagnosed patients attained complete remission. One of
the five newly diagnosed patients with signs of response to treatment died
early in the study due to common complications of this type of leukemia. Four
of 12 (33 percent) relapsed patients with the PML/RAR(alpha) molecular marker
also experienced complete remission. Three of these relapsed patients who
experienced complete remission were previously treated with all-trans retinoic
acid (ATRA). The other patient with an unusual molecular marker had an
excellent hematologic response.
Oral Panretin was generally well-tolerated, with headache and skin dryness
the, most common, clinically apparent adverse reactions.
The lowest dose that successfully induced complete remission was 50
mg/m(2) per day. The median time to complete remission was 51 days, with a
range of 23 to 61 days. The duration of remission for newly diagnosed
patients ranges from 10+ to 21+months, and is continuing in three of the four
patients who attained complete remission.
CONCLUSIONS
The findings show that Oral Panretin appears to induce durable complete
remissions in patients with retinoid-sensitive APL. Due to the stable plasma
concentrations at lower dose levels with Oral Panretin, the findings suggest a
possible role for the drug as a maintenance therapy in APL.
A Phase III multicenter study in the U.S., Canada and Europe, conducted by
Ligand on behalf of ALRT, comparing Oral Panretin to ATRA has been initiated,
according to Dr. Warrell.
ALRT was formed to continue the work of the Allergan Ligand Joint Venture
to discover and develop drugs based on retinoids, including Oral Panretin.
ALRT contracts with Ligand Pharmaceuticals and Allergan, Inc. to develop and
market its retinoid products.
This press release may contain certain forward-looking statements by ALRT
and actual results could differ materially from those described as a result of
factors, including, but not limited to the following: There can be no
assurance (a) that Oral Panretin or any product in the ALRT product pipeline,
will be successfully developed; (b) that regulatory approvals will be granted;
(c) that patient and physician acceptance of these products will be achieved;
or, (d) that final results of human clinical trials will be supportive of
regulatory approvals required to market products. ALRT undertakes no
obligation to update the statements contained in this press release after the
date hereof.
SOURCE Ligand Pharmaceuticals Inc.
CONTACT: Susan Atkins for ALRT, 619-550-7687 |
