second Phase 1 study in patients with multiple myeloma is planned to
begin later this year. The Company is engaged in partnering discussions
for the ENMD-2076 program.
-- MKC-1 - The primary response rate endpoint has been met for the efficacy
portion of the MKC-1 Phase 1/2 study in combination with Alimta(R)
(pemetrexed) in patients with non-small cell lung cancer. EntreMed is
considering possible options for further studies in NSCLC patients which
could include continuation of the current single arm study or a
randomized Phase 2 study in the same patient population if additional
financial resources are available.
-- ENMD-1198 - The Phase 1 study in advanced cancer patients is nearing
completion. A dose-limiting toxicity has been reached. The Phase 1
program may be expanded to identify combination therapies and target
indications. The mechanism-of-action for ENMD-1198 indicates that
prostate cancer may be a key indication. Possible next steps for the
clinical development of ENMD-1198 are being considered in light of our
objectives for 2009.
-- Panzem(R) RA - The Company completed a healthy volunteer study and
results were submitted to the FDA. The study results reaffirmed the
safety of Panzem(R), even at higher doses than are anticipated for the
treatment of rheumatoid arthritis. Based on the FDA's review, the
Company now has a clear path forward for clinical development and will
consider its options relative to our objectives for 2009. Possible next
steps for the RA program could include a drug-drug interaction (DDI)
clinical trial with methotrexate and chronic animal toxicology studies,
followed by a Phase 2 study in RA patien
|SOURCE EntreMed, Inc.|
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