Why Array Biopharma's MEK inhibitor pipeline may pay off (ARRY)
It is very early in the game, but Array Biopharma Inc. (Nasdaq: ARRY) may now have two MEK inhibitor drug candidates that may each eventually find markets in both both cancer and rheumatoid arthritis — ARRY-162 and ARRY-300.
The company announced this morning that it has filed an investigational new drug application for ARRY-162, and expects to start a Phase 1 cancer trial.
Array Biopharma also is in the midst of an ongoing Phase II trial for ARRY-162 in 200 patients with rheumatoid arthritis. The data in that trial is expected to be released in September, an event that’s a likely catalyst for the company’s stock.
Earlier this week, the company announced additional data for ARRY-162 in rheumatoid arthritis, saying that a four-week study of ARRY-162 in patients with stable RA receiving continued doses, showed that ARRY-162 was well tolerated and with no patients that discontinued the study due to an adverse event.
While ARRY-162 has been the headline-grabber, Array has another MEK inhibitor in ARRY-300 that also is a potential treatment for rheumatoid arthritis, and potentially cancer. The company began a Phase I trial for ARRY-300 early this year in RA. Back in January, Array’s Chief Scientific Officer Kevin Koch said, “We believe ARRY-300 is a best-in-class MEK inhibitor with superior pharmacologic properties.”
MEK is an enzyme that regulates the biosynthesis of inflammation. It also plays a key position in the signaling pathway that has been implicated in the development and progression of cancers. Array scientists have discovered potent MEK inhibitors that interfere with these biosynthetic processes.
Array has a total of five MEK inhibitors in total in its pipeline. And ARRY-162, and possibly ARRY-300 may have potential to treat multiple conditions.
Over time, thosemultiple MEK candidates and multiple potential markts may become valuable when the company seeks development partnerships. — Mike Tarsala
Array BioPharma trial failure highlights another anti-inflammatory (ARRY)
Read the Array BioPharma Inc. (Nasdaq: ARRY) press release carefully, and while the headline says its inflammation drug candidate ARRY-797 was well tolerated in two Phase I clinical trials, it becomes clear near the very bottom of the document that it failed the efficacy portion of the test.
The company now says it will discontinue development of ARRY-797 in chronic inflammatory diseases and will cease enrollment in enrollment of new patients in its current Phase II trial of the candidate.
If it’s any consolation, halting a trial with 170 patients is likely to save the company some dough. And this particular candidate was not very far along, so the Street likely didn’t even build in expectations for it.
The attention may now turn to Array’s ARRY-162, another anti-inflammatory that showed much more promising efficacy in its Phase 1 trial, and could eventually become a drug to help treat osteoarthritis and rheumatoid arthritis. Results from a Phase II study of that candidate is expected in the third quarter. — Mike Tarsala
Weekend of Cancer and Ocology Data at AACR; semi-preview for ASCO (ALTH, AMGN, ARIA, ARRY, AZN, BIIB, CELG, CRIS, IMMU, IMGN, INFI, MEDX, MNTA, ONCY, PFE, PCYC, SUPG, TELK, THLD)
This weekend will kick off a rather important oncology meeting, and it has a chance of setting the expectations for the highly anticipated ACSO (American Society of Clinical Oncology) annual meeting next month. The American Association for Cancer Research Meeting will take place in Denver, CO. and many of the smaller and larger cancer and disease biotech and drug companies will be presenting data. Amazingly enough, this will be the 100th annual meeting.
Allos Therapeutics, Inc. (NASDAQ: ALTH) will present data from an in vitro study examining the potency of pralatrexate in colon, breast, ovarian, lung, prostate, and head and neck cancer cell lines.
Amgen (NASDAQ: AMGN) had industry news earlier this week about its experimental drug called AMG 479 shows promise against pancreatic cancer. Amgen will also be presenting lung cancer data.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) will offer new preclinical data on deforolimus, its investigational mTOR inhibitor, AP24534, its investigational multi-targeted kinase inhibitor, and its investigational anaplastic lymphoma kinase (ALK) inhibitor.
Array BioPharma, Inc. (ARRY) has eighteen abstracts being presented at the meeting and will disclose findings in 7 new anti-cancer programs. Lung and colon cancer data are in these presentations.
Read more
Solid Developments for Rheumatoid Arthritis (ABT, ARRY, LLY, INCY, JNJ, SGP, RHHBY)
If you have followed the news on arthritis and rheumatoid arthritis (“RA”) for very long, this was a good week for the possible treatments of the disease. The annual congress of the European League Against Rheumatism in Paris, France took place and this was the venue for many study announcements. This is only a snippet of the data and a snippet of the companies presenting, but some of the companies were Abbott Laboratories, Array, Eli Lilly, Incyte, J&J, Schering-Plough, and Roche. This is a very debilitating condition that affects millions in the US and globally as our populations are all aging.
Abbott Laboratories (NYSE: ABT) announced that its long-term data from a study of 1,469 patients showed its drug Humira, in combination with a common treatment used to treat a type of arthritis pain, led to remission of the disease for up to seven years. After six months of therapy, patients’ symptoms improved, with additional improvements seen after two or more years.
Array BioPharma Inc. (NASDAQ: ARRY) reported on some additional positive results of its Phase I clinical trial of ARRY-162, its novel small molecule MEK inhibitor; and it reported positive results from a Phase I trial of ARRY-797, its modulator of inflammatory mediators in blood. The four-week study of ARRY-162 in patients with stable RA receiving continued doses, showed that ARRY-162 was well tolerated and with no patients that discontinued the study due to an adverse event. Its activity was predictable with no drug/drug interactions with ARRY-162 and methotrexate. ARRY-162 suppressed production of IL-1, IL-6 and TNF, suggesting that this treatment has the potential to reduce inflammation mediated by these cytokines in patients with RA.
Eli Lilly & Co. (NYSE: LLY) presented new data that suggests patients with osteoarthritis pain of the knee treated with 60 mg and 120 mg Cymbalta once daily experienced significant pain reduction. Patients taking duloxetine reported significant pain improvement compared to placebo within the first week of treatment that lasted throughout the 13-week trial. The results from a study of 231 patients were presented at the annual congress of the European League Against Rheumatism in Paris, France.
Incyte Corporation (NASDAQ: INCY) showed clinical results from a 28-day Phase IIa trial of INCB18424, its janus-associated kinase inhibitor, in patients with RA. Results from the first of four treatment groups demonstrated that the 15 mg twice-daily dose of INCB18424 was well tolerated and provided ACR20/50/70/90 response rates of 75%/50%/25%/17%, respectively, with responses seen as early as 1 week. These results suggest that INCB18424 has the potential to be more effective than currently available RA therapies.
J&J’s (NYSE: JNJ) Centocor and Schering-Plough Corporation (NYSE: SGP) showed data in their Phase III human anti-TNF-alpha monoclonal antibody study for an anti-TNF-alpha biologic therapy. Findings from two new Phase III studies showed that patients receiving every four-week injections of golimumab 50 mg and 100 mg and weekly methotrexate experienced significant improvements in the signs and symptoms of RA as well as in physical function and disease activity, with some patients achieving remission as measured by Disease Activity Score.
Roche Holding AG (OTC: RHHBY) said that it expects to increase sales of MabThera in 2008 compared to 2007 in the rheumatoid arthritis indication at the European League Against Rheumatism congress in Paris. Roche also noted that about 30% percent of rheumatoid arthritis patients who failed prior attempts to respond adequately to anti-TNF therapy saw some remission from the disease with Actemra. Rituximab results provide continued inhibition of structural damage after 2 years in patients with rheumatoid arthritis who had an inadequate response to tumor necrosis factor inhibition
And the best news is potentially for boozers. Scandinavian researchers conducted two studies, involving 2,750 people who drink alcohol regularly showing that it may reduce the risk of developing rheumatoid arthritis by up to 50%. This assessed environmental and genetic risk factors for rheumatoid arthritis; and 1,650 participants had the disease, and were questioned about their smoking and drinking habits. By the way, blowing out your liver isn’t a good substitute.
Jon Ogg
June 13, 2008
