mlkrborn
13 years ago
VIA 0.04 PHARMACEUTICALS INITIATES PHASE I DYSLIPIDEMIA TRIAL. Amazing still alive and kicking.
Jun 13, 2011 (Datamonitor via COMTEX) -- VIA Pharmaceuticals, Inc., a biotechnology company, has announced dosing of the first healthy volunteers in a Phase I clinical trial of VIA-3196, the company's orally administered, liver-directed thyroid hormone, or THR, beta receptor agonist for the treatment of high LDL cholesterol and other dyslipidemias including high triglycerides and elevated Lp(a).
As a beta-selective THR agonist, VIA-3196 is designed to specifically target receptors in the liver involved in metabolism and cholesterol regulation, and avoid side effects associated with THR activation outside the liver. In preclinical studies, VIA-3196 demonstrated a rapid reduction of non-HDL cholesterol, triglycerides, and fatty liver, and synergistic activity when used with statins.
The Phase I clinical trial of VIA-3196 is an ascending single-dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of VIA-3196 in healthy subjects. The single-center trial will enroll approximately seventy-two subjects and is being conducted by Cetero Research at its clinical study site in Fargo, ND. VIA-3196 was first developed by Hoffmann-La Roche Inc. and inlicensed by VIA Pharmaceuticals in December 2008.
"There remains a significant unmet need for new and more effective therapies that reduce the lipids linked to heart disease, particularly among high risk patients whose LDL cholesterol is not controlled by current therapies," said Rebecca Taub, MD, Senior vice president, R&D for VIA Pharmaceuticals. "By targeting a distinct mechanism of lipid metabolism, VIA-3196 has the potential to address hypercholesterolemia and other dyslipidemias when given alone or in combination with other lipid lowering agents. We are pleased that the first volunteers have been dosed with the study drug and no adverse events have been reported."
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mlkrborn
13 years ago
VIA Pharmaceuticals Announces First-in-Human Dosing of VIA-3196 for Treatment of Dyslipidemia
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Via Pharmaceuticals (PN) (USOTC:VIAP)
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VIA Pharmaceuticals, Inc. (PINKSHEETS: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease, today announced dosing of the first healthy volunteers in a Phase I clinical trial of VIA-3196, the Company's orally administered, liver-directed thyroid hormone (THR) beta receptor agonist for the treatment of high LDL cholesterol and other dyslipidemias including high triglycerides and elevated Lp(a).
As a beta-selective THR agonist, VIA-3196 is designed to specifically target receptors in the liver involved in metabolism and cholesterol regulation, and avoid side effects associated with THR activation outside the liver. In preclinical studies, VIA-3196 demonstrated a rapid reduction of non-HDL cholesterol, triglycerides, and fatty liver, and synergistic activity when used with statins.
"There remains a significant unmet need for new and more effective therapies that reduce the lipids linked to heart disease, particularly among high risk patients whose LDL cholesterol is not controlled by current therapies," said Rebecca Taub, MD, Senior Vice President, Research & Development for VIA Pharmaceuticals. "By targeting a distinct mechanism of lipid metabolism, VIA-3196 has the potential to address hypercholesterolemia and other dyslipidemias when given alone or in combination with other lipid lowering agents. We are pleased that the first volunteers have been dosed with the study drug and no adverse events have been reported."
"Today's announcement is a significant milestone for VIA Pharmaceuticals, and an important first step in the clinical development of VIA-3196," said Lawrence Cohen, PhD, Chief Executive Officer of VIA Pharmaceuticals.
The Phase I clinical trial of VIA-3196 (ClinicalTrials.gov ID: NCT01367873) is an ascending single-dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of VIA-3196 in healthy subjects. The single-center trial will enroll approximately seventy-two subjects and is being conducted by Cetero Research at its clinical study site in Fargo, ND. VIA-3196 was first developed by Hoffmann-La Roche Inc. and inlicensed by VIA Pharmaceuticals in December 2008.
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic diseases. VIA's drug candidates include VIA-3196 and other compounds to address underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation. For more information, visit: http://www.viapharmaceuticals.com.
mlkrborn
14 years ago
Their recent report:
NOTES TO THE UNAUDITED CONDENSED FINANCIAL STATEMENTS
1. ORGANIZATION
Overview — VIA Pharmaceuticals, Inc. (“VIA,” the “Company,” “we,” “our,” or “us”), incorporated in Delaware in June 2004 and headquartered in San Francisco, California, is a development stage biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease. The Company is building a pipeline of small molecule drugs that target the underlying causes of cardiovascular and metabolic disease, including vascular inflammation, high cholesterol, high triglycerides and insulin sensitization/diabetes. During 2005, the Company in-licensed a small molecule compound, VIA-2291, which targets an unmet medical need of reducing atherosclerotic plaque inflammation, an underlying cause of atherosclerosis and its complications, including heart attack and stroke. Atherosclerosis, depending on its severity and the location of the artery it affects, may result in major adverse cardiovascular events (“MACE”), such as heart attack and stroke. During 2006, the Company initiated two Phase 2 clinical trials of VIA-2291 in patients undergoing a carotid endarterectomy (“CEA”), and in patients at risk for acute coronary syndrome (“ACS”). During 2007, the Company initiated a third Phase 2 clinical trial where ACS patients undergo Positron Emission Tomography with flurodeoxyglucose tracer (“FDG-PET”), an experimental non-invasive imaging technique to measure the effect of treatment of VIA-2291 on uptake of FDG into the vascular wall. Effective during the first quarter of 2009, the Company licensed from Hoffman-LaRoche Inc. and Hoffmann-LaRoche Ltd. (collectively “Roche”) the exclusive worldwide rights to two sets of compounds. The first license is for Roche’s thyroid hormone receptor beta agonist, a clinically ready candidate for the control of cholesterol, triglyceride levels and potential in insulin sensitization/diabetes. The second license is for multiple compounds from Roche’s preclinical diacylglycerol acyl transferase 1 metabolic disorders program.
Through June 30, 2010, the Company has been primarily engaged in developing initial procedures and product technology, screening and in-licensing of target compounds, clinical trial activity, and raising capital. To fund operations, VIA has been raising cash through debt, a merger and equity financings. The Company is organized and operates as one operating segment.
Merger — On June 5, 2007, Corautus completed a merger (the “Merger”) with privately-held VIA Pharmaceuticals, Inc. pursuant to the Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), dated February 7, 2007, by and among Corautus, Resurgens Merger Corp., a Delaware corporation and a wholly owned subsidiary of Corautus (“Resurgens”), and privately-held VIA Pharmaceuticals, Inc. Pursuant to the Merger Agreement, Resurgens merged with and into privately-held VIA Pharmaceuticals, Inc., which continued as the surviving company as a wholly-owned subsidiary of Corautus. Immediately following the effectiveness of the Merger on June 5, 2007, privately-held VIA Pharmaceuticals, Inc. merged (the “Parent-Subsidiary Merger”) with and into Corautus, pursuant to which Corautus continued as the surviving corporation. Immediately following the Parent-Subsidiary Merger, Corautus changed its corporate name from “Corautus Genetics Inc.” to “VIA Pharmaceuticals, Inc.” Unless otherwise specified, as used throughout these unaudited condensed financial statements, the “Company,” “we,” “us,” and “our” refers to the business of the combined company after the merger (the “Merger”) with Corautus Genetics Inc. (“Corautus”) on June 5, 2007 and the business of privately-held VIA Pharmaceuticals, Inc. prior to the Merger. Unless specifically noted otherwise, as used throughout these unaudited condensed financial statements, “Corautus Genetics Inc.” or “Corautus” refers to the business of Corautus prior to the Merger.
Going Concern — From inception, the Company has incurred expenses in research and development activities without generating any revenues to offset those expenses and the Company does not expect to generate revenues in the near future. The Company has incurred losses and negative cash flow from operating activities from inception, and as of June 30, 2010, the Company had an accumulated net deficit of approximately $86.6 million. Until the Company can establish profitable operations to finance its cash requirements, the Company’s ability to meet its obligations in the ordinary course of business is dependent upon its ability to raise substantial additional capital through public or private equity or debt financings, the establishment of credit or other funding facilities, collaborative or other strategic arrangements with corporate sources or other sources of financing, the availability of which cannot be assured. On June 5, 2007, the Company raised $11.1 million through the Merger with Corautus to cover existing obligations and provide operating cash flows. In July 2007, the Company entered into a securities purchase agreement that provided for issuance of 10,288,065 shares of common stock for approximately $25.0 million in gross proceeds.
4
Table of Contents
As more fully described in Note 6 in the notes to the unaudited condensed financial statements, in March 2009, the Company entered into a Note and Warrant Purchase Agreement (the “Loan Agreement”) with its principal stockholder and one of its affiliates (the “Lenders”) whereby the Lenders agreed to lend to the Company in the aggregate up to $10.0 million. The Company secured the loan with all of its assets, including the Company’s intellectual property. On March 12, 2009, the Company borrowed the initial $2.0 million available under the Loan Agreement. Subsequently, the Company made $2.0 million borrowings under the Loan Agreement on May 19, 2009, June 29, 2009, August 14, 2009, respectively, and the Company borrowed the final $2.0 million available under the Loan Agreement on September 11, 2009. According to the terms of the original Loan Agreement, the debt was due to the Lenders on September 14, 2009. The parties agreed to extend the repayment terms on various dates in 2009, and on February 26, 2010, the Lenders agreed to modify the Loan Agreement to further extend the repayment terms to April 1, 2010. The Lenders did not modify the interest rate or offer any concessions in the amendments to the Loan Agreements. The Company failed to repay the debt and all related interest to the Lenders due on April 1, 2010.
As more fully described in Note 6 in the notes to the unaudited condensed financial statements, in March 2010, the Company entered into a second Note and Warrant Purchase Agreement (the “2010 Loan Agreement”) with its principal stockholder and one of its affiliates (the “Lenders”) whereby the Lenders agreed to lend to the Company in the aggregate up to $3.0 million, pursuant to the terms of promissory notes (collectively, the “2010 Notes”) delivered under the 2010 Loan Agreement. The Company secured the loan with all of its assets, including the Company’s intellectual property. On March 29, 2010, the Company borrowed the initial $1.25 million available under the 2010 Loan Agreement. Subsequently, the Company made $100,000, $200,000 and $300,000 borrowings under the 2010 Loan Agreement on May 26, 2010, June 4, 2010, and June 29, 2010, respectively. According to the terms of the 2010 Loan Agreement, the debt is due to the Lenders on December 31, 2010. As described in Note 14 in the notes to the unaudited condensed financial statements, the Company borrowed an additional $850,000 in subsequent borrowings in July 2010. Subject to the Lenders’ approval, the Company may borrow in the aggregate up to an additional $300,000 at subsequent closings pursuant to the terms of the 2010 Loan Agreement and 2010 Notes. The 2010 Notes are secured by a lien on all of the assets of the Company. Amounts borrowed under the 2010 Notes accrue interest at the rate of 15% per annum, which increases to 18% per annum following an event of default. Unless earlier paid in accordance with the terms of the 2010 Notes, all unpaid principal and accrued interest shall become fully due and payable on the earlier to occur of (i) December 31, 2010, (ii) the closing of a debt, equity or combined debt/equity financing resulting in gross proceeds or available credit to the Company of not less than $20,000,000, and (iii) the closing of a transaction in which the Company sells, conveys, licenses or otherwise disposes of a majority of its assets or is acquired by way of a merger, consolidation, reorganization or other transaction or series of transactions pursuant to which stockholders of the Company prior to such acquisition own less than 50% of the voting interests in the surviving or resulting entity.
The Company had $158,000 in cash at June 30, 2010. Subject to the Lenders’ approval, the Company may borrow in the aggregate up to an additional $300,000 at subsequent closings pursuant to the terms of the 2010 Loan Agreement. Management believes that, under normal continuing operations, the total amount of cash available under the 2010 Loan Agreement, if borrowed, will enable the Company to meet only a portion of its current obligations. Management does not believe that existing cash resources will be sufficient to enable the Company to meet its ongoing working capital requirements for the next twelve months and the Company will need to raise substantial additional funding in the near term to repay amounts owed under the Loan Agreement and 2010 Loan Agreement, and to meet its ongoing working capital requirements. As a result, there are substantial doubts that the Company will be able to continue as a going concern and, therefore, may be unable to realize its assets and discharge its liabilities in the normal course of business. The unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or to amounts and classifications of liabilities that may be necessary should the Company be unable to continue as a going concern.
mlkrborn
14 years ago
VIA Pharmaceuticals and MHI Announce Publication of VIA-2291 5-Lipoxygenase Inhibitor Clinical Study Data in Circulation: Cardio
Date : 05/20/2010 @ 7:30AM
Source : MarketWire
Stock : VIA Pharmaceuticals (VIAP)
Quote : 0.16 0.0 (0.00%) @ 7:13AM
VIA Pharmaceuticals and MHI Announce Publication of VIA-2291 5-Lipoxygenase Inhibitor Clinical Study Data in Circulation: Cardio
SAN FRANCISCO, CA and MONTREAL -- (Marketwire)
05/20/10
VIA Pharmaceuticals, Inc. (PINKSHEETS: VIAP), a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic diseases, and The Montreal Heart Institute today announced the publication of clinical trial data from a study of VIA-2291, a 5-Lipoxygenase inhibitor (5-LO), in volume 3, issue 3 of the American Heart Association journal Circulation: Cardiovascular Imaging, published May 19, 2010.
"Despite standard-of-care treatment, patients with recent acute coronary syndromes remain at high risk of recurrent vascular events, and this risk is greater in patients with evidence of ongoing inflammation," said Dr. Jean-Claude Tardif, Director of the Montreal Heart Institute Research Centre, professor of medicine at the University of Montreal, principal investigator of the VIA-2291 ACS trial and the lead author of the publication. "VIA-2291 is designed to target the underlying inflammatory disease process active in atherosclerosis, including the reduction of leukotrienes, an approach not addressed by currently available treatment. These newly published data strongly support the evaluation of VIA-2291 in larger outcome trials."
The publication includes data from VIA's ACS study, a randomized, double-blind, placebo controlled Phase 2 study of VIA-2291 in 191 patients who recently experienced acute coronary syndromes (ACS), including heart attack or unstable angina. Patients on standard care medications (statins, blood pressure medications, and platelet inhibitors) were treated once daily for 12 weeks with one of three doses of VIA-2291 or placebo. The study met its primary endpoint by demonstrating a statistically significant, dose-dependent inhibition of whole blood stimulated leukotriene LTB4 production at 12 weeks (P < 0.0001) demonstrating greater than 80% inhibition in 90% of patients. Leukotrienes are important mediators of inflammation believed to be involved in the development and progression of atherosclerotic plaque. VIA-2291 is designed to be a selective, potent and reversible inhibitor of 5-LO, a key enzyme in the biosynthesis of leukotrienes. A significant reduction of urine leukotriene LTE4, a marker of systemic leukotriene production, was also obtained in all dose groups, a secondary endpoint of the study. The drug was found to be well tolerated, with no serious adverse events considered related to study drug.
A subset of 93 patients were also evaluated in a 64-slice coronary CT examination at baseline and at 24 weeks to study VIA-2291's effect over a longer timeframe. Among evaluable patients, new coronary plaques were observed in 5 of 18 (27.8%) placebo and 2 of 42 (4.8%) VIA-2291-treated patients (P=0.01). A reduction in non-calcified plaque volume at 24 weeks versus placebo was observed in VIA-2291-treated groups in the patients in whom this endpoint was analyzable (P < 0.01).
Although unchanged at 12 weeks in the main study, concentrations of high-sensitivity C-reactive protein (hs-CRP), a validated marker of inflammation and risk for cardiovascular diseases, were reduced by 67% in the VIA-2291 100-mg treatment group relative to placebo at 24 weeks (P=0.0002) among patients in the extension sub-study.
The publication can be found on the American Heart Association's website at http://circimaging.ahajournals.org.
About VIA Pharmaceuticals, Inc.
VIA Pharmaceuticals, Inc. is a biotechnology company focused on the development of compounds for the treatment of cardiovascular and metabolic disease. VIA's lead candidate, VIA-2291, targets a significant unmet medical need: reducing inflammation in plaque, which is an underlying cause of atherosclerosis and its complications, including heart attack and stroke. In addition, VIA's pipeline of drug candidates includes other compounds to address other underlying causes of cardiovascular disease: high cholesterol, diabetes and inflammation. For more information, visit: http://www.viapharmaceuticals.com.
About the Montreal Heart Institute
Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in prevention, ultra-specialized care, professionals training, clinical and fundamental research, and assessment of new technologies. The Institute is part of a vast network of excellence in health formed by the Université de Montréal and its affiliated institutions. To learn more about the Institute, please visit our website at www.icm-mhi.org.
downsideup
15 years ago
What ? What publicity ? Vicious shorts ? Ummm ? Where? Bashers tirelessly savaging the company ? What are you seeing that I'm not ? I don't see anyone is even paying attention ?
VIAP is about as far off the well trod path of the mainstream as you can possibly get ? There are fewer than a dozen posts total, here, in the last month, with four of those being from you and two of them from me ?
ZZZzzzzz ?
All I see is a continuation pattern of a stock that clearly is twisting in the wind while their key sponsor dithers and tightens the reigns more and more over time, while their short term month to month financing is converted into more and more share dilution, and then, the too predictable response you should expect to see when a stock is being de-listed ?
If this issue is being "beaten down" by the market actors playing here, the only ones with enough interest to make the effort in doing that... are the insiders.
I think you generally need to carefully consider what it is that the insiders are doing, and why they are doing it, as they are, and when they are... and then try to align your interest with theirs as best you can, IF you think they are likely to find a way to make a success that will create a benefit for themselves...
If you figure out what they are doing, and how, and figure out how to do align your interest with theirs, here... let me know ?
For now, I don't have a good enough bead on this... not watching closely enough... to know what the timing issues are, or what the forward risks in the current financing package are, especially following the NASDAQ de-listing. I assume that will make any future money they get cost quite a lot more.
Otherwise ? What else is there to be surprised about ? Was it surprising that they didn't hold a party to announce "WELCOME TO PINKIE LAND, VIAP HOLDERS" ???
IF the plan here is for a takedown being executed by the insiders, Bay et al, etc., prior to popping the "really good news" about the results of the extended Phase II trials ? It will be vastly easier for them to do whatever it is they want to do with this as a pink.
For now, I'm not buying the insider driven conspiracy theory purposed to take all the shares in dilution before all the really good news starts coming out.
It simply looks like they seriously whiffed on the effort they had made... because the science they based their effort on wasn't nearly close enough... and since then they haven't been able to put the wheels back on it in convincing fashion.
For those here still holding shares and hoping for better, soon... I hope I'm wrong. I just don't see a solid reason to expect good news will be coming out of the blue any time soon.
I haven't called to chat with anyone at the company in a long time. If you are holding out hope for a near term change in their future prospects, either on the technical side or in the financing package, I'd call and chat with them to see what they say about the direction they are heading now... and what needs to happen to make that sort of change in fortunes possible. If you do that... post it here to share with us ?
Otherwise, I expect that this already well off the main path issue is likely to trade as an even more well off the path pinkie from here... so that the financing schedules, the burn rates, and the charts probably matter more than what they are doing in the lab right now ?
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