ARCA: A Rose by Any Other Name…

ARCA Discovery has changed their name to ARCA Biopharma. The modification in moniker more appropriately correlates with the enterprises graduation from a discovery to now a commercialization focus as demonstrated by a planned 2008 NDA filing with the FDA. A beautiful new website and logo has been rolled out as well. Take a look (here). The exciting news continues to be announced.

Interestingly if you go to http://ARCAbiopharma.com it will provide a visitor with an invalid hostname error as the new site remains on http://ARCAdiscovery.com. If anyone at ARCA is reading this be certain to simply create a url redirect from pharma to discovery until the final switch is made.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

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ARCA Discovery: Moving on Up…

…To a deluxe apartment, wait, make that a deluxe new office in the sky. ARCA Discovery is currently headquartered in LoDo, the labs however at last check remain at the Colorado Science + Technology Park @ Fitzsimons and, I would venture to guess shall remain there as plans are finalized to make the move north up the I-36 corridor to 15,000 new sq ft of luxurious office space at 8001 Arista Place adjacent to the new Broomfield Event Center.

The new headquarters will place ARCA just a stones throw from Allos Therapeutics (NASDAQ: ALTH) and Gilead (NASDAQ: GILD) to their south and Replidyne (NASDAQ: RDYN) and GlobeImmune to their north. Welcome to the I-36 Bio Corridor.

*NOTE* Feel the power of the Colorado BioScience Association (HERE)!
*NOTE* Take a look at the new Boulder Biotech Company Tree (HERE)!
*NOTE* Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

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And the CLSDF Readers Have Spoken!

The winner of the CLSDF Reader’s Choice Company of the Year, 2007 goes to... GlobeImmune, Inc., who took home a commanding 43% of the vote. ARCA Discovery and ValveXchange came in tied for second place. Congratulations to President and CEO Tim Rodell, MD and the other 60+ folks in Louisville who are doing outstanding work.

For those of you who do not know: GlobeImmune is a biopharmaceutical company pioneering the discovery, development and manufacturing of potent, targeted molecular immunotherapies called Tarmogens for the treatment of infectious diseases and cancer.

Tarmogens (Targeted Molecular Immunogens) are whole, heat-killed recombinant Saccharomyces cerevisiae yeast genetically modified to express one or more protein targets that stimulate the immune system against diseased cells. The whole heat-killed yeast, with the antigen expressed inside, is the product that is administered to the patient. Tarmogens program the cytotoxic T cells in the patient's immune system to eliminate diseased cells containing the antigen(s). GlobeImmune's patented Tarmogen platform has a number of advantages over current approaches because Tarmogens generate a potent T cell response, are not neutralized by the host immune system upon repeated administration, do not require a custom vaccine approach and are simple to manufacture.

The Company's lead product , GI-5005 a Tarmogen for the treatment of chronic hepatitis C infection has completed a placebo-controlled, dose-escalation Phase Ib clinical trial. A randomized, placebo controlled Phase II trial in combination with standard of care will begin is underway. GI-4000, a Tarmogen for the treatment of various mutated Ras-mediated cancers, is in a randomized, placebo-controlled, multi-center Phase II trial for the treatment of patients with resectable pancreas cancer in combination with adjuvant gemcitabine.

Interestingly too, the $41.6M Series C financing closed in 2007 ranked among the 20 largest venture rounds in the country. Here is the full list courtesy of the National Venture Capital Association:

1. Zogenix - $78.8M
2. Ception Therapeutics - $77.7M
3. Targanta Therapeutics - $70M
4. Portola Pharmaceuticals - $70M
5. AVEO Pharmaceuticals - $58.5M
6. Cogentus Pharmaceuticals - $55M
7. Phenomix Corporation - $55M
8. Sagent Pharmaceuticals - $53M
9. Microbia - $50M
10. Sangart - $50M
11. Ambit Biosciences - $49.3M
12. Spine Wave - $45M
13. Nereus Pharmaceuticals - $45M
14. QuatRx Pharmaceuticals - $44M
15. Novalar Pharmaceuticals - $42
    
16. MREVA Medical - $42M
17. Xcellerex - $41.84M
18. Deciphera Pharmaceuticals - $41.5M
19. Agensys - $41.31M
20. GlobeImmune - $41.16M
    

***NOTE*** Read the new eBook CLSDF 2007 - What's In A Year? (HERE)!

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Gen Eng News: More CO Action!

If memory serves me correctly I have waxed on in the past about my affinity for Genetic Engineering News and often highlighted the journal when a Colorado company ended up in print there. Well the love story continues with the 15 November issue where Carol Potera composed a three-page treatise on the Colorado Science + Technology Park @ Fitzsimons and beyond.

A few companies highlighted include 1) MBC Pharma who is focused upon bone disease such as osteoporosis and cancer metastases, patients who die from breast, prostate or lung cancer have bone metastases and, presentation with bone metastases is correlated with shorter survival 2) MycoLogics, a company near and dear to my heart that is among other pursuits focused upon developing prophylactic and therapeutic approaches to Leishmaniasis, a disease where 350 million people in developing countries are at risk. 3) Caveo Therapeutics who is working on the discovery and development of biopharmaceuticals to treat and cure hematalogic conditions by inhibiting certain families of tyrosine kinases 4) ARCA Discovery who is developing genetically targeted therapies for heart failure and other cardiovascular disease, an NDA for bucindolol is expected to be filed shortly, and finally 5) Lohocla Research is a discovery and development company specializing in addiction, neurological disorders and related biomarkers for companion diagnostics.

You can read the article (here).

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Personalized Medicine Colorado Style

It is exciting to see how the Colorado community is heating up around biomarkers and diagnostics. What is even hotter to me is when one of these molecular diagnostics forge an intimate relationship with and become a companion to enabling a genetically targeted therapeutic.

Well, we here in Colorado are lucky to have one such company pursuing that endeavor, ARCA Discovery. CLSDF has previously highligted ARCA so we won’t start from the beginning, what should be highlighted is is that the recently reported data on bucindolol, ARCA’s next-generation beta-blocker beta-blocker and vasodilator for heart failure and other indications, continues to show promise in becoming the first genetically-targeted cardiovascular drug, that is thanks to ARCA’s founders who have demonstrated genetic polymorphisms that interact with bucindolol's unique pharmacology to modify patient response.

For fear of putting some readers to sleep by detailing the numerous study results lets allow Michael Bristow, MD., Ph.D. Founder, Chair and Chief Science and Medical Officer of ARCA Discovery to sum it up...

"The data presented today provided us with more evidence supporting the potential of bucindolol as a targeted therapy for the treatment of heart failure. Importantly, we are encouraged by the data demonstrating bucindolol’s effect in preventing atrial fibrillation and life threatening ventricular arrhythmia, showing the promise for bucindolol in additional indications. In addition, the BEST trial investigators were able to extend the observation of pharmacogenetic targeting of bucindolol to benefits on cardiovascular hospitalizations, which in effect gives the drug and targeting concept a broader application.”

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ARCA Discovery: $18M Series B

ARCA Discovery, Inc. closed an $18M Series B led by Skyline Ventures and additional new investor InterWest Partners, previous investors Atlas Ventures, Boulder Ventures and the Peierls Foundation also participated in the round.

ARCA is aiming for an NDA submission in 2007 for Bucindolol, a next-generation beta-blocker and vasodilator for heart failure, and plans to seek approval of the drug concurrent with a genetic test to assist physicians in determining whether bucindolol is an appropriate therapy for their patients.

A targeted approach based upon genetic markers (beta-1 and alpha-2-c adrenergic receptors).

Colorado…at the forefront of personalized medicine!

Mike Bristow, M.D., Ph.D. LIVE Broadcast

LIVE Thursday 8:00 - 9:00am MST

Dr. Bristow was the principal founder, chief science & medical officer and director of Myogen. In November of 2006 Gilead acquired Myogen for $52.50/share or a whopping $2.5 billion! Dr. Bristow is Professor of Medicine and the former Head of Cardiology, University of Colorado Health Sciences Center, the Co-Director of the Colorado Cardiovascular Institute and is presently founder, chair and CSMO of ARCA Discovery.

Thursday 8 March @ 8:00am MST Dr. Bristow will be discussing LIVE...

The Founding and Development of Myogen: Keys to Success and Lessons Learned

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I would love to hear about your viewing experience. Please contact me with your candid feedback on the quality of video and audio and a prize (TBD) will be coming your way as a token of my appreciation.
Email: arubenstein@rnaventures.com

ARCA Discovery: Names CEO

ARCA Discovery, Inc., (Denver,CO) a biopharmaceutical company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, announced that Richard B. Brewer has been appointed President and CEO.

Prior to ARCA Discovery Mr. Brewer was managing partner at Crest Asset Management, previously, Mr. Brewer was president and CEO of Scios, Inc. (NYSE: JNJ), served as chief operating officer of Heartport, and was Senior Vice President of Genentech (NASDAQ: DNA).

ARCA’s lead product Bucindolol is a next-generation beta-blocker for advanced heart failure and other indications, which promises to be the first genetically-targeted cardiovascular drug. Extensive Phase III data shows that bucindolol is likely to be an effective and well-tolerated therapy for many heart failure patients that can be targeted to those patients most likely to respond favorably – thereby overcoming a major problem with current treatment approaches. A large substudy from a Phase III trial published recently in the Proceedings of the National Academy of Sciences shows that a common genetic variation in the beta-1 adrenergic receptor may help doctors identify heart failure patients who may benefit most from bucindolol. Data presented at the 2005 American Heart Association Meeting from the same DNA substudy demonstrates further enhancement of bucindolol’s efficacy by targeting both the beta-1 variant and a variant of the alpha-2c-adrenergic receptor. ARCA Discovery has exclusive, worldwide rights to bucindolol and intends to seek FDA approval of the drug next year.

15 Million Ark Shells for ARCA Discovery

ARCA Discovery, Inc., a company developing genetically-targeted therapies for heart failure and other cardiovascular diseases, today announced the completion of a $15 million venture capital financing. The financing was led by Atlas Venture. Boulder Ventures, which provided the original seed financing for ARCA, and Pequot Capital Management also participated in the financing.

This round of financing will enable the filing of a New Drug Application for bucindolol, the first genetically-targeted cardiovascular drug. Bucindolol has been evaluated in Phase III clinical trials involving more than 3,000 patients with advanced heart failure and myocardial ischemia. In conjunction with this financing, Dr. Jean Francois Formela, a Senior Partner with Atlas will join the ARCA Board of Directors along with Kyle Lefkoff of Boulder Ventures, Dr. John Zabriskie, former CEO of Upjohn/Pharmacia and NEN Life Sciences, Dr. Frank Bullock, former SVP of Research at Schering Plough, and Dr. Mike Bristow. Dr. Bristow is also the founder and former Chief Scientific Officer of Myogen, Inc. As President and CEO of ARCA, Dr. Bristow will retain the title of Founder and Scientific Advisor to Myogen, and will remain a member of Myogen's Board of Directors. ARCA's co-founders are Timothy D. Hoogheem and Christopher D. Ozeroff, and its scientific co-founders are Dr. Stephen Liggett of the University of Maryland, and Dr. J. David Port of the University of Colorado.

Colorado 2006 life science fund raising is off to the races…