If the agreement is similar to what Sucampo has with Abbot, it is a great news.
Cancer Chemother Pharmacol. 2014 Oct 17. [Epub ahead of print]
More than half of colorectal tumors harbor activating mutations in RAS/RAF proteins. Selumetinib (AZD6244, ARRY-142886) is a small molecule kinase inhibitor targeting MEK kinase, downstream of RAS. We examined the efficacy and safety of selumetinib with irinotecan in second-line therapy.
Patients with K-RAS mutated colorectal cancer, progressing on first-line oxaliplatin-based chemotherapy with bevacizumab, were eligible for this multicenter open-label phase I/II trial. In part A, a dose was determined using a standard "3 + 3" design; in part B, efficacy was determined. The primary endpoint was RECIST response rate. Historical data for irinotecan were used as reference. Secondary endpoints included progression-free survival and overall survival.
Thirty-two patients entered the study, and 31 were treated. All had K-RAS exon 2 mutated tumors. In phase I, the recommended oral dose of selumetinib was 75 mg twice per day with intravenous (IV) irinotecan, 180 mg/m2 every 2 weeks. Three patients (9.7 %) had partial response . Sixteen patients (51.6 %) had stable disease for ≥4 weeks, including three 1 year. The most common grade 3 adverse events included diarrhea, neutropenia, fatigue, anemia, nausea, and dehydration. The study was terminated before a pre-planned accrual of 45 subjects.
Despite termination before full accrual, the point estimates of RR and median PFS show promising results, suggesting that further investigations of MEK inhibition in the treatment of metastatic colorectal cancer are warranted. Studies combining MEK inhibitors with cytotoxics or other targeted agents may lead to improved clinical activity based on the emerging preclinical data.
Oct 19 2014, 09:49 ET | About: Shire PLC (SHPG) | By: Eli Hoffmann, SA News Editor
Shire (NASDAQ:SHPG) may look to acquire an American rival after AbbVie pulled its proposed $55B takeover.
Possible targets include rare diseases specialist NPS Pharma (NASDAQ:NPSP) and Cubist Pharma (NASDAQ:CBST), which makes a treatment for superbug MRSA.
Source: Sunday Times
Binimetinib in NRAS-mutant melanoma (NEMO trial) if no unexpected problems. Do they have seven phase 3 trials or six?
It could be a reason why a SP is declining. Of course, there is GAAP vs non-GAAP accounting, but in official documents GAAP rules. From 4thQ, Spectrum should start reporting positive EPS on GAAP basis and we will see better perception from investing community.
Item 8.01. Other Events.
Under the terms of the February 19, 2009 agreement between the Company's affiliate and Abbott Japan Co. Ltd. ("Abbott Japan") to develop and commercialize lubiprostone in Japan for the treatment of CIC, Abbott Japan will pay a commercial milestone of $2.5 million within forty-five (45) days after the end of the month during which the first occurrence of annual net sales of lubiprostone in Japan exceeds JPY5,000,000,000. After confirming the October 2014 notification by Abbott Japan that annual net sales had exceeded JPY5,000,000,000 by the end of September 2014, the Company invoiced Abbott Japan for the $2.5 million commercial milestone on October 6, 2014.
Excellent news. Should relieve pressure on SP.
September 30th, 2014
WallachBeth Capital started coverage on shares of Sucampo Pharmaceuticals (NASDAQ:SCMP) in a research note issued on Tuesday. The firm set a “buy” rating and a $8.00 price target on the stock.
Some good information about time frame you can find in recent 2ndQ CC
"Next for unoprostone isopropyl, the compound currently marketed as RESCULA in glaucoma and which has orphan drug status in retinitis pigmentosa in both the U.S. and Europe. In the first quarter of 2015, we will obtain a first look at one year data from the two year development program in RP in Japan. This trial is being funded by our partner R-Tech Ueno. In the meantime, we’re working with regulators in the U.S. and in Europe to determine a go forward plan for development in these markets. Taken together, these will provide us with information we will need to decide on our next steps in RP by mid 2015 with the potential to expand the program outside of Japan into the global markets.
Additional clinical data has also emerged supporting the therapeutic potential of unoprostone in dry AMD or more specifically, geographic atrophy. We believe that this may offer proof-of-principle for a parallel path development and dry related macular degeneration, another disease affecting the back of the eye. Dry AMD is the most common type of macular degeneration and it’s anticipated that by 2020 more than 12 million patients will have dry AMD. More than a 1 million of these patients suffer from its advanced form of geographic atrophy in the U.S. alone with an even higher number of patients in Europe that are threatened by this debilitating loss of vision. There are currently no drugs approved for its treatment, so this is a disease area with significant potential."
Disagree. While several Captisol-conjugated drugs are on the market, no drugs developed based on Lapscovery technology are there. Safety is still an unanswered question.
I’m getting ready for transplant. I’ve been told that during melphalan, I need to chomp on ice for 30 minutes. Do I really have to?
YES! Melphalan can cause severe sores from your mouth down your esophagus. By chomping on ice, you have a great chance of avoiding those sores. It doesn’t sound fun but 30 minutes of ice can help you avoid weeks of debilitating discomfort. Get crushed ice and pack your cheeks full of it. Chomp on it. Do not drink anything warm. Cold ice only. If you need help with the ice, try popsicles or frozen juice. Whatever you do, stay focused. You can do it. Ice is good. Ice is your friend.
Belinostat and abexinostat are both pan-HDAC inhibitors.
SUNNYVALE, Calif. and SURESNES, France, Sept. 25, 2014 /PRNewswire/ -- Pharmacyclics, Inc. (PCYC) and Servier today announced that they have mutually and amicably ended their collaboration pertaining to the ex-U.S. development of Pharmacyclics' pan-HDAC inhibitor compounds involving abexinostat, thereby returning global development and commercialization rights to Pharmacyclics.
Top authors during last week:
Why didn't they include apaziquone Phase 3 results in the Near Term Company Milestones? It is way more important than Go-No Go.
"Just not sure how they would move these trials on the pipeline chart if the trials were not active"
It is just a slight move within the Phase 2 cell. One explanation is that a person who designed the presentation is not very experienced in working with PowerPoint program.
There is a table in 10-K from 2013 showing how much company spent on each drug. There was no meaningful spending on SPI-1620. Actually, SPI-1620 is not present in the Table. Should be in the category "Other development drugs".