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About Senesco's cancer technology:
Cancer
We have shown that up regulating our patented and patent-pending genes kills human cancer cells in pre-clinical experiments performed with cell lines derived from tumors. We isolated and identified these genes in human cells.
As discussed elsewhere, the immune system targets abnormal cells to die as part of its surveillance system to ensure good health. Tumors arise when these abnormal cells are unable to die due to mutations in their genetically triggered apoptosis "pathways". There are two major apoptosis pathways triggered by the immune system: the DNA damage pathway and the death receptor pathway. We have demonstrated that our genes induce apoptosis in human cancer cell lines through both of these pathways.
In a DNA damage pathway model, we found that when our genes were up regulated in a human carcinoma cell line, virtually 100% of the cancer cells were killed. This pathway contains the well-studied tumor killing gene p53, which promotes apoptosis, as well as the bcl-2 gene, which suppresses apoptosis. Our findings indicate that Factor 5A activates the DNA damage pathway by both up-regulating the expression of p53 and by down-regulating the expression of bcl-2.
On the basis of these findings, we conducted live animal tumor studies to elucidate further the role of our genes and the mechanisms of their action. In our initial mouse studies, the treated mice had a 92% reduction in tumor load. Coincident with this tumor load reduction was an 88% reduction in VEGF, a growth factor which increases vascularization of tumors which aids their growth.
These data led to a mouse longevity study which employed tumor-forming B16F0 melanoma cancer cells. Two control groups of nine mice each received placebo treatments and a test group of ten mice received eIF-5A1 intratumorally every other day. The median survival of the control mice was 7 days post-treatment, whereas the mice that received eIF-5A1 treatment had a median survival of 25 days post-treatment (P< 0.001). The enhanced survival time of the eIF-5A1 -treated mice equates to 3.5 fold or a 250% increase compared to the control mice. Tumor regression, and even remission in one of the treated mice, was seen.
SOMX having another good day.
GLTA.
La Jolla Pharmaceutical Company Provides Voting Update - More Votes Needed or La Jolla Will Likely Close
SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (NASDAQ: LJPC - News) today provided an update on the Company’s upcoming special meeting of stockholders on February 26, 2010 at 3:00 p.m. Pacific Time to vote on its proposed merger with Adamis Pharmaceuticals Corporation (OTCBB: ADMP - News).
YOUR VOTE IS CRITICAL. To date, holders of only 9% of La Jolla’s outstanding common stock have voted their shares but in order to hold the special stockholders’ meeting on February 26, 2010, holders of a majority of the outstanding shares must vote. To date, those stockholders who have voted have overwhelmingly supported the merger proposals, including the reverse stock split. Only stockholders who held La Jolla stock on January 22, 2010 are eligible to vote.
If You Haven’t Received Your Voting Materials – please vote by contacting our proxy vote solicitor, Mackenzie Partners, Inc. as follows:
e-mail at proxy@mackenziepartners.com
call toll free at (800) 322-2885
call collect at (212) 929-5500.
Mackenzie Partners will be able to provide you with voting materials and instructions on how to vote telephonically or through your broker. You may also contact La Jolla by e-mail at gail.sloan@ljpc.com or by telephone at (858) 452-6600.
If You Have Received Your Voting Materials - please vote telephonically or via the internet as instructed in your voting materials in order to ensure your vote is counted. If you have any questions about voting or need assistance, please contact Mackenzie Partners.
If the Merger With Adamis is Not Completed, the La Jolla Board of Directors Will Most Likely Close the Business. If La Jolla is closed, we currently expect to return up to $0.02 - $0.03 per share to stockholders.
All Votes Must be Received Before Friday, February 26th. La Jolla’s Board of Directors and Management believe that the merger is the only chance of stockholder upside and therefore urge its stockholders to act immediately and vote.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information and Where to Find It
The joint proxy statement/prospectus in connection with the merger with Adamis was mailed to La Jolla stockholders on or about February 12, 2010. Investors and security holders of both La Jolla and Adamis are urged to read the joint proxy statement/prospectus because it contains important information about La Jolla, Adamis and the proposed transaction. The joint proxy statement/prospectus, and any other documents filed by La Jolla with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov, by contacting La Jolla Investor Relations by e-mail at gail.sloan@ljpc.com or by telephone at (858) 452-6600. La Jolla and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from La Jolla’s stockholders in favor of the proposed transaction. Information about the directors and executive officers of La Jolla and their respective interests in the proposed transaction is available in the joint proxy statement/prospectus.
FORWARD-LOOKING STATEMENTS
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: the expected liquidation value of La Jolla if the merger is not completed, the ability to complete the merger with Adamis and the potential future value of La Jolla stock post-merger. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause La Jolla’s actual results to be materially different from these forward-looking statements. Certain of these risks, uncertainties, and other factors are described in greater detail in the joint proxy statement/prospectus, as well as in La Jolla’s filings from time to time with the SEC, which La Jolla strongly urges you to read and consider, all of which are available free of charge on the SEC’s web site at http://www.sec.gov. La Jolla expressly disclaims any intent to update any forward-looking statements.
La Jolla Pharmaceutical Company Provides Voting Update - More Votes Needed or La Jolla Will Likely Close
SAN DIEGO--(BUSINESS WIRE)--La Jolla Pharmaceutical Company (NASDAQ: LJPC - News) today provided an update on the Company’s upcoming special meeting of stockholders on February 26, 2010 at 3:00 p.m. Pacific Time to vote on its proposed merger with Adamis Pharmaceuticals Corporation (OTCBB: ADMP - News).
YOUR VOTE IS CRITICAL. To date, holders of only 9% of La Jolla’s outstanding common stock have voted their shares but in order to hold the special stockholders’ meeting on February 26, 2010, holders of a majority of the outstanding shares must vote. To date, those stockholders who have voted have overwhelmingly supported the merger proposals, including the reverse stock split. Only stockholders who held La Jolla stock on January 22, 2010 are eligible to vote.
If You Haven’t Received Your Voting Materials – please vote by contacting our proxy vote solicitor, Mackenzie Partners, Inc. as follows:
e-mail at proxy@mackenziepartners.com
call toll free at (800) 322-2885
call collect at (212) 929-5500.
Mackenzie Partners will be able to provide you with voting materials and instructions on how to vote telephonically or through your broker. You may also contact La Jolla by e-mail at gail.sloan@ljpc.com or by telephone at (858) 452-6600.
If You Have Received Your Voting Materials - please vote telephonically or via the internet as instructed in your voting materials in order to ensure your vote is counted. If you have any questions about voting or need assistance, please contact Mackenzie Partners.
If the Merger With Adamis is Not Completed, the La Jolla Board of Directors Will Most Likely Close the Business. If La Jolla is closed, we currently expect to return up to $0.02 - $0.03 per share to stockholders.
All Votes Must be Received Before Friday, February 26th. La Jolla’s Board of Directors and Management believe that the merger is the only chance of stockholder upside and therefore urge its stockholders to act immediately and vote.
This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Additional Information and Where to Find It
The joint proxy statement/prospectus in connection with the merger with Adamis was mailed to La Jolla stockholders on or about February 12, 2010. Investors and security holders of both La Jolla and Adamis are urged to read the joint proxy statement/prospectus because it contains important information about La Jolla, Adamis and the proposed transaction. The joint proxy statement/prospectus, and any other documents filed by La Jolla with the SEC, may be obtained free of charge at the SEC web site at www.sec.gov, by contacting La Jolla Investor Relations by e-mail at gail.sloan@ljpc.com or by telephone at (858) 452-6600. La Jolla and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from La Jolla’s stockholders in favor of the proposed transaction. Information about the directors and executive officers of La Jolla and their respective interests in the proposed transaction is available in the joint proxy statement/prospectus.
FORWARD-LOOKING STATEMENTS
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operations or future financial performance, including, but not limited to the following statements: the expected liquidation value of La Jolla if the merger is not completed, the ability to complete the merger with Adamis and the potential future value of La Jolla stock post-merger. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause La Jolla’s actual results to be materially different from these forward-looking statements. Certain of these risks, uncertainties, and other factors are described in greater detail in the joint proxy statement/prospectus, as well as in La Jolla’s filings from time to time with the SEC, which La Jolla strongly urges you to read and consider, all of which are available free of charge on the SEC’s web site at http://www.sec.gov. La Jolla expressly disclaims any intent to update any forward-looking statements.
Thanks! I wonder if it's going to fill this morning's gap or not.
GL.
Anadys Pharmaceuticals Reports Fourth Quarter and Year-End 2009 Financial Results and Highlights
SAN DIEGO, Feb. 24 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS - News), a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C, today reported its financial results and program highlights for the fourth quarter and year ended December 31, 2009.
"In the past year we've significantly advanced the development of ANA598, our wholly owned non-nucleoside polymerase inhibitor in development for the treatment of hepatitis C," said Steve Worland, Ph.D., President and CEO of Anadys. Â "The twelve week Phase II results announced today demonstrate the ability of ANA598 to significantly accelerate the rate of patients achieving undetectable levels of virus when added to current treatment. Â The durability of antiviral response through twelve weeks and a very favorable safety profile to date position ANA598 as one of the most attractive and advanced polymerase inhibitors in the HCV development landscape today, ready for clinical trials exploring the use of ANA598 in combination with other direct antivirals."
Recent Highlights
Today, Anadys reported preliminary results from an ongoing Phase II study demonstrating that 73% of hepatitis C patients treated with 200 mg ANA598 twice daily in combination with pegylated interferon and ribavirin (SOC) achieved undetectable levels of virus (<15 IU/mL) at week 12, known as complete Early Virological Response or cEVR. Â No patient experienced viral rebound on ANA598. Â ANA598 was well tolerated through twelve weeks, with no serious adverse events reported and a profile of adverse events in the ANA598 group comparable to the group receiving SOC alone.
Financial Results
As of December 31, 2009, the Company's cash, cash equivalents and securities available-for-sale totaled $20.5 million compared to $27.9 million as of December 31, 2008. Â The decrease in cash, cash equivalents and securities available-for-sale is the result of our cash utilization to fund operations during 2009 partially offset by proceeds of approximately $16.0 million received from a "registered direct" offering of common stock and warrants in early June 2009.
Total operating expenses were $5.6 million for the fourth quarter of 2009, compared to $8.9 million for the fourth quarter of 2008. Â Included as a component of Anadys' operating expenses were non-cash, share-based expenses of $0.4 million and $0.7 million for the fourth quarter of 2009 and 2008, respectively.
Research and development expenses were $4.0 million for the fourth quarter of 2009, compared to $6.9 million for the fourth quarter of 2008. The $2.9 million decrease was primarily attributable to cost savings associated with our strategic restructuring initiated in June 2009 which included a $1.5 million decrease in ANA773 development costs. Â
General and administrative expenses were $1.6 million for the fourth quarter of 2009, compared to $2.0 million for the fourth quarter of 2008. Â The $0.4 million decrease primarily resulted from cost savings associated with our strategic restructuring and the relocation of our corporate headquarters to a smaller facility during July 2009.
The net loss was $4.3 million for the fourth quarter of 2009, compared to a net loss of $8.5 million for the fourth quarter of 2008. Included in the net loss for the fourth quarter of 2009 is a $1.3 million gain resulting from a decrease in the liability associated with our common stock warrants from September 30, 2009 to December 31, 2009.  The warrants were issued in connection with our "registered direct" offering in early June 2009.  Basic and diluted net loss per common share was $0.11 in the fourth quarter of 2009, compared to $0.30 in the fourth quarter of 2008.  Non-cash share-based expense resulted in a $0.01 and $0.02 increase in basic and diluted net loss per share for the fourth quarter of 2009 and 2008, respectively.
For the twelve months ended December 31, 2009, Anadys reported a net loss of $27.3 million, compared to $32.4 million for the same period last year. Â Basic and diluted net loss per common share was $0.81 and $1.13 for the twelve months ended December 31, 2009 and 2008, respectively.
2009 Development Program Highlights
ANA598-non-nucleoside HCV polymerase inhibitor in Phase II development.
Reported Positive Phase II Combination Data. Â In December 2009, Anadys announced preliminary results from a planned interim analysis of data at four weeks for the first dose cohort, 200 mg given twice daily (bid), in an ongoing Phase II study of ANA598 in combination with pegylated interferon and ribavirin (SOC) in HCV patients. Â At each week, a greater proportion of patients receiving ANA598 plus SOC achieved undetectable levels of virus compared to patients receiving placebo plus SOC, with 56% of patients in the ANA598 group having undetectable levels of virus at week four. Â ANA598 was well tolerated through four weeks, with no serious adverse events reported. Â
In the ongoing Phase II study, treatment-naive genotype 1 patients are to receive ANA598 or placebo in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) for 12 weeks at dose levels of 200 mg or 400 mg both given twice daily (bid), each with a loading dose of 800 mg bid on day one.  After week 12, patients are to continue receiving SOC.  Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48.  The primary endpoint of the study is the proportion of patients who achieve undetectable levels of virus at week 12 (defined as complete Early Virological Response, or cEVR).  Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable levels of virus at week 4 (defined as Rapid Virological Response, or RVR).  Patients will be followed for 24 weeks after stopping therapy to determine the rate of Sustained Virological Response, or SVR.  Approximately 90 patients were to be and have been enrolled in this study â?? with approximately 30 patients receiving ANA598 and 15 receiving placebo at each dose level.  The study is being managed by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison, M.D. and is being conducted at a number of clinical sites in the United States.
Reported Potent Antiviral Activity/Good Tolerability at EASL. Â In April 2009, Anadys reported data at the 44th Annual Meeting of the European Association of the Study of Liver Disease demonstrating potent antiviral activity and good tolerability of ANA598 as a single agent at all dose levels in a Phase Ib study, in which ANA598 was dosed for three days in HCV patients. Â No patient at any dose level showed evidence of viral rebound while on ANA598 and there were no serious adverse events reported.
Reported 14-day Healthy Volunteer Study Results. In April 2009, Anadys reported that ANA598 was generally well-tolerated in all cohorts with no serious adverse events in a 14-day monotherapy study of ANA598 in healthy volunteers. Â Pharmacokinetic results from this trial confirmed the plasma half-life of ANA598 of approximately 24 hours, and demonstrated that steady-state levels of ANA598 in plasma are reached after six to seven days of dosing.
Favorable Toxicology Profile Established. Â In October 2009, Anadys completed its long-term, chronic toxicology studies of ANA598 and reported that the No Observed Adverse Effect Level, or NOAEL, is 1000 mg/kg (the highest dose tested) in both species tested. Â The completed studies confirm the favorable toxicology profile of ANA598 and support dosing durations of as long as one year if desirable in future clinical studies.
ANA773-oral inducer of endogenous interferons that acts via the toll like receptor 7 (TLR7) pathway.
Proof of Concept Achieved in Phase I Clinical Trial in HCV. Â In August 2009, Anadys announced proof of concept results from a completed Phase I clinical trial of ANA773 in HCV. Â Patients receiving 2000 mg ANA773 every other day over 10 days experienced a 1.3 log10 mean maximal decline in viral load. Â Based on these results, Anadys believes that ANA773 continues to hold promise as a potential replacement for injectable interferon products in HCV therapy. Â As part of the strategic restructuring implemented in mid-2009, Anadys has deferred initiation of any subsequent trials of ANA773 in HCV.
Phase I Clinical Trial in Oncology. Â In 2009 Anadys completed enrollment through the 800 mg dose cohort in a trial of ANA773 in oncology patients in which patients were to receive ANA773 every other day over 14 days followed by a 14-day period off drug, with repeated cycles permitted in patients whose disease did not progress. Â ANA773 was well tolerated at all doses tested. Â ANA773 induced several biomarkers of immunological stimulation at higher doses. Â Two patients from this trial with stable disease continue to receive ANA773. Â As part of the strategic restructuring implemented in mid-2009, Anadys elected not to enroll any patients in previously planned higher dose cohorts. Â
2009 Operational Highlights
Closed Registered Direct Financing. Â In June 2009, Anadys closed a "registered direct" offering of common stock and warrants in which net proceeds of approximately $16.0 million were raised. Â Proceeds from the transaction are being used to further the development of ANA598, as well as for other general corporate purposes.
Focused Operations on Development of ANA598. Â In June 2009, Anadys effected a strategic restructuring and facilities reduction in order to focus its operations on the continued development of ANA598 in the ongoing Phase II combination study.
Conference Call Webcast and Slides
Anadys will host a conference call at 5:00 pm Eastern  Standard Time today to discuss its fourth quarter year-end 2009 financial results and highlights and to present the 12-week results at 200 mg bid in the ongoing ANA598 Phase II study.  A live webcast of the call, including accompanying slides, will be available online at www.anadyspharma.com.  A telephone replay will also be available approximately one hour after completion of the call.  To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 92658014.  The webcast and telephone replay will be available through March 10, 2010.
About Anadys
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. Â The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines. Â The Company is developing ANA598, a non-nucleoside polymerase inhibitor for the treatment of hepatitis C. Â The Company has also investigated the potential of ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7, or TLR7, pathway in hepatitis C.
Safe Harbor Statement
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Â Such statements include, but are not limited to, references to (i) the belief that the durability of antiviral response through twelve weeks and a very favorable safety profile to date position ANA598 as one of the most attractive and advanced polymerase inhibitors in the HCV development landscape today, ready for clinical trials exploring the use of ANA598 in combination with other direct antivirals; (ii) assessments of the safety and tolerability profile of ANA598 based on the 200 mg bid 12 week results; (iii) the ability for patients to achieve a SVR in the ANA598 Phase II study; and (iv) the belief that ANA773 holds promise as a potential replacement for injectable interferon products in HCV therapy. Â Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Â For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 will not have unforeseen safety issues or will continue to have favorable results as the Phase II trial progresses. Â In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments and its ability to obtain additional funding to support its operations. Â Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2008 and Anadys' Form 10-Q for the quarter ended September 30, 2009. Â All forward-looking statements are qualified in their entirety by this cautionary statement. Â Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Condensed Consolidated Financial Statements
Anadys Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(In thousands except per share amounts)
(Unaudited)
Twelve Months Ended Three Months Ended
December 31, December 31,
------------ ------------
2009 2008 2009 2008
---- ---- ---- ----
Operating expenses
Research and development 3,948 6,902 19,494 25,993
General and
administrative 1,632 2,005 8,243 8,109
----- ----- ----- -----
Total operating
expenses (1) 5,580 8,907 27,737 34,102
Interest income and
other, net 44 390 610 1,700
Gain (loss) from
valuation of common
stock warrant liability 1,279 - (151) -
----- --- ---- ---
Total other income,
net 1,323 390 459 1,700
Net loss (1) $(4,257) $(8,517) $(27,278) $(32,402)
======= ======= ======== ========
Net loss per share,
basic and diluted (1) $(0.11) $(0.30) $(0.81) $(1.13)
====== ====== ====== ======
Share used in
calculating net loss
per share, basic and
diluted 37,326 28,797 33,775 28,750
====== ====== ====== ======
(1) Includes non-cash share-based expenses of $384 and $699 or approximately $0.01 and $0.02 effect on basic and diluted net loss per common share for the three months ended December 31, 2009 and 2008, respectively. Research and development expense and general and administrative expense includes $123 and $261, respectively, of non-cash share-based expenses for the three months ended December 31, 2009. Includes non-cash share-based expenses of $2,714 and $2,763 or approximately $0.08 and $0.10 effect on basic and diluted net loss per common share for the twelve months ended December 31, 2009 and 2008, respectively. Research and development expense and general and administrative expense includes $1,354 and $1,360, respectively, of non-cash share-based expenses for the twelve months ended December 31, 2009. Â
Anadys Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(In thousands)
December 31, December 31,
2009 2008
---- ----
(Unaudited) (Audited)
Assets
Cash, cash equivalents and securities
available-for-sale $20,490 $27,936
Other current assets 559 2,202
Noncurrent assets 686 1,536
--- -----
Total assets $21,735 $31,674
======= =======
Liabilities and Stockholders' Equity
Current liabilities $3,383 $5,813
Common stock warrant liability 3,897 -
Other long-term liabilities 26 36
Stockholders' equity 14,429 25,825
------ ------
Total liabilities and stockholders'
equity $21,735 $31,674
======= =======
Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche Inc.
ANA598 Demonstrates 73% cEVR in Combination With Interferon and Ribavirin
No Viral Rebound Observed During 12 Weeks of ANA598 Dosing
Positive Safety Data with AE Profile Comparable to Control Group
Company to Review Data During Q4 Conference Call at 5:00 PM EST Today
SAN DIEGO, Feb. 24 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS - News) today announced preliminary results from an ongoing Phase II study demonstrating that 73% of hepatitis C patients treated with 200 mg ANA598 twice daily in combination with pegylated interferon and ribavirin (SOC) achieved undetectable levels of virus (<15 IU/mL) at week 12, known as complete Early Virological Response or cEVR.
No patient experienced viral rebound on ANA598. Â ANA598 was well tolerated through twelve weeks, with no serious adverse events reported and a profile of adverse events in the ANA598 group comparable to the group receiving SOC alone.
"The 73% cEVR demonstrated by ANA598 is comparable to the most advanced protease inhibitors currently in development for HCV," said Steve Worland, Ph.D., President and CEO of Anadys. Â "The durability of antiviral response through twelve weeks reflects ANA598's potency and long plasma half-life and suggests that resistance is unlikely to be a challenge to the use of ANA598 in appropriate combinations. Â Coupled with a very favorable safety profile to date, these results position ANA598 as an attractive candidate to advance in development, especially in combination with other direct antivirals."
Preliminary Antiviral Response Assessment
Proportion of Patients with Undetectable Levels of Virus (<15 IU/mL) by Week
Week 4
(RVR)
Week 6
Week 8
Week 10
Week 12*
(cEVR)
ANA598 + SOC
56%
65%
69%
73%
73%
Placebo+ SOC
20%
27%
47%
54%
71%
*At week 12, N=26 for the ANA598 group and 14 for the placebo group. Â One patient receiving ANA598 who had undetectable levels of virus at last measurement (week 4) and one patient receiving placebo who had a viral load of 150,000 IU/mL at last measurement (week 10) became unavailable and are excluded from weeks subsequent to their last measurement. Â The placebo values represent approximately half the overall placebo group, with the remainder of the placebo group being dosed presently, concurrently with patients receiving ANA598 400 mg bid.
ANA598 demonstrated comparable potency against genotypes 1a and 1b at twelve weeks, with cEVR rates of 74% and 71% respectively. Â No patient receiving ANA598 experienced viral rebound (defined as >1 log10 increase from a prior measurement) through week 12 and all patients who achieved undetectable levels of virus at any time during the 12 week period remained at undetectable levels at week 12.
Preliminary Safety Assessment
ANA598 at 200 mg given twice daily (bid) demonstrated a favorable safety and tolerability profile through 12 weeks, although conclusions regarding safety and tolerability cannot be made until additional results in more patients and potentially over longer duration are known. Â The incidence of all adverse events was similar between the active and placebo groups, with reported adverse events being typical for patients treated with interferon and ribavirin. Â There were no serious adverse events reported. Â The incidence of rash was comparable between groups and consistent with historical reports of rash rates due to interferon and ribavirin. Â In the ANA598 group 41% of patients (12/29) developed a rash while 33% (5/15) of patients in the placebo group developed a rash. Â Eleven of the twelve instances of rash in the ANA598 group were mild. Â One patient in the ANA598 group experienced a grade 3 rash which began resolving rapidly upon stopping all study medication. Â Per protocol, this patient resumed interferon/ribavirin alone and continued in the study. Â The five instances of rash in the placebo group were mild. Â 44 patients in the first cohort received at least one dose of study medications and are included in the safety database. Â Safety information for patients receiving placebo represents approximately half the overall placebo group, with the remainder of the placebo group being dosed presently, concurrently with patients receiving ANA598 400 mg bid.
Phase II Combination Study
In December 2009, Anadys reported positive initial antiviral response and safety results from the 200 mg bid dose cohort based on a planned interim analysis of data at four weeks. Â In the group receiving ANA598 added to SOC, there was a steady increase in the percentage of patients with undetectable levels of virus from week 1 through week 4, with 56% of patients achieving undetectable levels of virus at week 4 (defined as Rapid Virological Response or RVR), compared to 20% of patients receiving placebo plus SOC achieving an RVR. Â No patient receiving ANA598 experienced viral rebound (defined as >1 log10 increase from a prior measurement) through week 4. Â ANA598 also demonstrated a favorable safety profile through four weeks. Â There were no serious adverse events reported and the profile of adverse events reported was as expected for patients receiving SOC alone, with comparable rates observed between the ANA598 and placebo arms. Â
In the ongoing Phase II study, treatment-naive genotype 1 patients are to receive ANA598 or placebo in combination with Pegasys® (peginterferon alfa-2a) and Copegus® (ribavirin, USP) for 12 weeks at dose levels of 200 mg or 400 mg both given twice daily (bid), each with a loading dose of 800 mg bid on day one.  After week 12, patients are to continue receiving SOC.  Patients who achieve undetectable levels of virus at weeks 4 and 12 will be randomized to stop all treatment at week 24 or 48.  The primary endpoint of the study is the proportion of patients who achieve undetectable levels of virus at week 12 (defined as complete Early Virological Response, or cEVR).  Additional endpoints include safety and tolerability as well as the proportion of patients with undetectable levels of virus at week 4 (defined as Rapid Virological Response, or RVR).  Patients will be followed for 24 weeks after stopping therapy to determine the rate of Sustained Virological Response, or SVR.  Approximately 90 patients are planned to be enrolled in this study â?? with approximately 30 patients receiving ANA598 and 15 receiving placebo at each dose level.  The study is being managed by the Duke Clinical Research Institute (DCRI) under the leadership of John McHutchison, M.D. and is being conducted at a number of clinical sites in the United States. Â
About ANA598
ANA598 is a non-nucleoside inhibitor of the HCV RNA polymerase and is wholly owned by Anadys.  Anadys has completed three Phase I clinical studies of ANA598 that have demonstrated potent antiviral activity and good tolerability.  In a monotherapy study in treatment-naïve genotype 1 patients, treatment with ANA598 for three days led to median end-of-treatment declines in viral load ranging from 2.4 to 2.9 log10 in three separate dose groups.  No patient at any dose level showed evidence of viral rebound while on ANA598, and there were no serious adverse events.  Those patients from the monotherapy study who subsequently received pegylated interferon and ribavirin all exhibited further viral load decline, demonstrating that viral variants revealed by brief treatment with ANA598 remain susceptible to current SOC, consistent with prior in vitro results.
Anadys has completed two long-term chronic toxicology studies of ANA598 (26 weeks duration in rats and 39 weeks duration in monkeys). Â The No Observed Adverse Effect Level, or NOAEL, is 1000 mg/kg, the highest dose tested, in both the rat and monkey. Â The completed toxicology studies support the ongoing Phase II clinical study as well as future clinical studies of longer duration.
Anadys has presented in vitro data supporting the use of ANA598 in combination with interferon-alpha as well as with direct antivirals currently in development. Â In particular, data has shown that ANA598 is synergistic in vitro with interferon-alpha as well as representative HCV protease and polymerase inhibitors. Â In vitro combination treatment at clinically relevant concentrations of interferon-alpha and ANA598 results in clearance of HCV RNA from cells rather than selection of resistant isolates. Â Furthermore, ANA598 retains full activity in vitro against mutations conferring resistance to protease inhibitors, nucleoside polymerase inhibitors and non-nucleoside polymerase inhibitors that act at binding sites distinct from that of ANA598, while protease and nucleoside polymerase inhibitors retain full activity in vitro against mutations conferring resistance to ANA598.
ANA598 has received Fast Track Status from the FDA for the treatment of chronic hepatitis C.
Conference Call Webcast and Slides
Anadys will hold a conference call and webcast today, Wednesday, February 24, 2010 at 5:00 p.m. Eastern Standard Time to discuss its fourth quarter and year end 2009 financial results and to discuss the 12 week safety and antiviral response data for the 200 mg bid cohort in the ongoing Phase II combination trial. Â A live webcast of the call, including accompanying slides, will be available online at www.anadyspharma.com. Â A telephone replay with slides will also be available approximately one hour after completion of the call. Â To access the telephone replay, dial 888-286-8010 (domestic) or 617-801-6888 (international), passcode 92658014. Â The webcast and telephone replay will be available through March 10, 2010.
Safe Harbor Statement
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Â Such statements include, but are not limited to, references to (i) the belief that the durability of antiviral response through twelve weeks reflects ANA598's potency and long plasma half-life and suggests that resistance is unlikely to be a challenge to the use of ANA598 in appropriate combinations; (ii) assessments of the safety and tolerability profile of ANA598 based on the 200 mg bid 12 week results; (iii) future development activities with ANA598, including combination trials with other direct antivirals; and (iv) the ability for patients to achieve a SVR in the ANA598 study. Â Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. Â For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that ANA598 will not have unforeseen safety issues or will continue to have favorable results as the Phase II trial progresses. Â In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, its ability to successfully develop and market products, difficulties or delays in its preclinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments and its ability to obtain additional funding to support its operations. Â Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-K for the year ended December 31, 2008 and Anadys' Form 10-Q for the quarter ended September 30, 2009. Â All forward-looking statements are qualified in their entirety by this cautionary statement. Â Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
Pegasys® and Copegus® are registered trademarks of Hoffman-La Roche Inc.
SOMX up again today, in the 3.60s at the moment. Could possibly hit $4+ by EOW, IMO.
GLTA.
HRBR up 20%+
Holding up really well in the 3.60s...
GL.
Here's a link to the 4Q earnings call: http://www.videonewswire.com/event.asp?id=66382
GLTA
Heska Corporation (NASDAQ: HSKA) sells advanced veterinary diagnostic and other specialty veterinary products. Heska's state-of-the-art offerings to its customers include diagnostic instruments and supplies as well as single use, point-of-care tests, vaccines and pharmaceuticals. The company's core focus is on the canine and feline markets where it strives to provide high value products and unparalleled customer support to veterinarians.
Insider transactions: http://www.mffais.com/hska
Heska Announces Q4 and Annual 2009 Results
Heska Corporation (Nasdaq: HSKA, "Heska" or the "Company") today reported financial results for its fourth quarter and the year ended December 31, 2009.
"In the fourth quarter of 2009, we produced revenue growth in both of our operating segments, increased our gross margin and decreased our operating expenses compared to the fourth quarter of 2008. For full year 2009, our team generated over $4 million in operating income - the second best result in company history, despite a challenging economic environment," said Robert Grieve, Heska's Chairman and CEO. "We also placed our first DRI-CHEM(R) 7000 Veterinary Chemistry Analyzers with our customers in the fourth quarter of 2009. We have been pleased with customer interest in this fine new product, which represents a line extension in our chemistry offering and is the fastest multi-patient clinical chemistry analyzer available to the veterinary in-clinic market. We also are excited by the prospects for another new product in 2010, the VitalPath(TM) Blood Gas and Electrolyte Analyzer, which we expect to begin shipping to our customers in the near future."
Investor Conference Call
Management will conduct a conference call on Monday, February 22, 2010 at 1:00 p.m. MST (3:00 p.m. EST) to discuss the fourth quarter and year-end 2009 financial results. To participate, dial (877) 941-2333 (domestic) or (480) 629-9723 (international); the conference call access number is 4218183. The conference call will also be broadcast live over the Internet at http://www.heska.com. To listen, simply log on to the web at this address at least ten minutes prior to the start of the call to register, download and install any necessary audio software. Telephone replays of the conference call will be available for playback until March 8, 2010. The telephone replay may be accessed by dialing (800) 406-7325 (domestic) or (303) 590-3030 (international). The webcast replay may be accessed from Heska's home page at www.heska.com until March 8, 2010.
About Heska
Heska Corporation (Nasdaq: HSKA) sells advanced veterinary diagnostic and other specialty veterinary products. Heska's state-of-the-art offerings to its customers include diagnostic instruments and supplies as well as single use, point-of-care tests, pharmaceuticals and vaccines. The company's core focus is on the canine and feline markets where it strives to provide high value products and unparalleled customer support to veterinarians. For further information on Heska and its products, visit the company's website at www.heska.com.
Forward-Looking Statements
This announcement contains forward-looking statements regarding Heska's future financial and operating results. These statements are based on current expectations and are subject to a number of risks and uncertainties. Investors should note that there is an inherent risk in using past results, including trends, to predict future outcomes. In addition, factors that could affect the business and financial results of Heska generally include the following: uncertainties related to the access to products from Abbott Point of Care Inc. as of November 1, 2009, which represent approximately 15% of Heska's revenue for the year ended December 31, 2009, including the impact of the loss of related profits on Heska's year-over-year performance; risks inherent in relying on perceived initial customer interest to indicate future market acceptance and success of any given product; uncertainties related to product performance and market acceptance of any product planned, but not yet placed, with customers; risks related to any change in Heska's strategy, including Heska's recent decision to terminate its contractual agreements with most domestic third-party distributors who carry Heska's full product line, and the year-over-year and future impact of any such decision; uncertainties regarding Heska's reliance on third parties to whom Heska has granted substantial marketing rights to certain of Heska's existing products and whom may be large Heska customers; uncertainties regarding Heska's ability to successfully market and sell its products in an economically sustainable manner; risks related to Heska's reliance on third parties to properly and timely complete certain research and development activities; competition, including uncertainties regarding the impact of new products competitors have recently launched or may launch in the future; uncertainties related to Heska's ability to maintain its listing on the Nasdaq Capital Market; uncertainties regarding Heska's ability to generate profits and positive cash flow in future periods; risks regarding Heska's reliance on third-party suppliers, which is substantial and could have significant negative consequences if Heska were to lose access to a product line; uncertainties regarding overall economic conditions and the affect of these conditions on Heska's business, which may change as compared to historical results, as well as Heska's accuracy in predicting these and related matters; and the risks set forth in Heska's filings and future filings with the Securities and Exchange Commission, including those set forth in Heska's Annual Report on Form 10-K for the year ended December 31, 2008 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2009.
Financial Table Follows:
View data
Consolidated Statements of Operations
In Thousands, Except per Share Amounts
(unaudited)
Three Months Twelve Months
Ended Ended
----- -----
December 31, December 31,
------------ ------------
2008 2009 2008 2009
---- ---- ---- ----
Revenue, net:
Core companion animal health $13,667 $14,541 $68,140 $66,449
Other vaccines, pharmaceuticals
and products 1,767 2,817 13,513 9,229
----- ----- ------ -----
Total revenue, net 15,434 17,358 81,653 75,678
------ ------ ------ ------
Cost of revenue 11,093 10,723 52,809 47,219
------ ------ ------ ------
Gross profit 4,341 6,635 28,844 28,459
----- ----- ------ ------
Operating expenses:
Selling and marketing 3,616 3,449 17,640 14,524
Research and development 489 410 1,951 1,718
General and administrative 2,161 1,918 8,917 8,173
Restructuring expenses 785 - 785 -
Other 232 - 232 -
--- --- --- ---
Total operating expenses 7,283 5,777 29,525 24,415
----- ----- ------ ------
Operating income (loss) (2,942) 858 (681) 4,044
Interest and other expense, net 140 113 640 306
--- --- --- ---
Income (loss) before income taxes (3,082) 745 (1,321) 3,738
Income tax expense (benefit) (1,215) 285 (471) 1,496
------ --- ---- -----
Net income (loss) $(1,867) $460 $(850) $2,242
======= ==== ===== ======
Basic net income (loss) per share $(0.04) $0.01 $(0.02) $0.04
====== ===== ====== =====
Diluted net income (loss) per share $(0.04) $0.01 $(0.02) $0.04
====== ===== ====== =====
Shares used for basic net income
(loss) per share 51,821 52,123 51,674 52,068
====== ====== ====== ======
Shares used for diluted net income
(loss) per share 51,821 52,199 51,674 52,115
====== ====== ====== ======
Balance Sheet Data
In Thousands (unaudited)
December 31, December 31,
2008 2009
---- ----
Cash and cash equivalents $4,705 $5,400
Total current assets 31,290 28,493
Total assets 70,438 64,134
Line of credit 11,042 4,201
Current portion of long-term debt 770 381
Total current liabilities 22,228 14,107
Long-term debt, net of current portion 381 -
Stockholders' equity 42,523 45,055
Consolidated Statements of Operations In Thousands, Except per Share Amounts (unaudited) Three Months Twelve Months Ended Ended ----- ----- December 31, December 31, ------------ ------------ 2008 2009 2008 2009 ---- ---- ---- ---- Revenue, net: Core companion animal health $13,667 $14,541 $68,140 $66,449 Other vaccines, pharmaceuticals and products 1,767 2,817 13,513 9,229 ----- ----- ------ ----- Total revenue, net 15,434 17,358 81,653 75,678 ------ ------ ------ ------ Cost of revenue 11,093 10,723 52,809 47,219 ------ ------ ------ ------ Gross profit 4,341 6,635 28,844 28,459 ----- ----- ------ ------ Operating expenses: Selling and marketing 3,616 3,449 17,640 14,524 Research and development 489 410 1,951 1,718 General and administrative 2,161 1,918 8,917 8,173 Restructuring expenses 785 - 785 - Other 232 - 232 - --- --- --- --- Total operating expenses 7,283 5,777 29,525 24,415 ----- ----- ------ ------ Operating income (loss) (2,942) 858 (681) 4,044 Interest and other expense, net 140 113 640 306 --- --- --- --- Income (loss) before income taxes (3,082) 745 (1,321) 3,738 Income tax expense (benefit) (1,215) 285 (471) 1,496 ------ --- ---- ----- Net income (loss) $(1,867) $460 $(850) $2,242 ======= ==== ===== ====== Basic net income (loss) per share $(0.04) $0.01 $(0.02) $0.04 ====== ===== ====== ===== Diluted net income (loss) per share $(0.04) $0.01 $(0.02) $0.04 ====== ===== ====== ===== Shares used for basic net income (loss) per share 51,821 52,123 51,674 52,068 ====== ====== ====== ====== Shares used for diluted net income (loss) per share 51,821 52,199 51,674 52,115 ====== ====== ====== ====== Balance Sheet Data In Thousands (unaudited) December 31, December 31, 2008 2009 ---- ---- Cash and cash equivalents $4,705 $5,400 Total current assets 31,290 28,493 Total assets 70,438 64,134 Line of credit 11,042 4,201 Current portion of long-term debt 770 381 Total current liabilities 22,228 14,107 Long-term debt, net of current portion 381 - Stockholders' equity 42,523 45,055
SOURCE Heska Corporation
Harbor BioSciences to Receive Patent for Apoptone(R) Cancer Treatment
SAN DIEGO, Feb. 24 /PRNewswire-FirstCall/ -- Harbor BioSciences, Inc. (Nasdaq:HRBR - News) today announced that the company has received a notice of allowance from the United States Patent Office of patent claims covering the use of its lead product candidate Apoptone®. The patent claims cover the use of Apoptone to treat prostate cancer, breast cancer and benign prostatic hypertrophy. Apoptone (HE3235) is a novel synthetic steroid analog of a dihydrotestosterone metabolite and has been found to stimulate cell death (apoptosis) in animal models of prostate and breast cancers.
Apoptone is a first-in-class oral compound in a Phase I/IIa clinical trial in late-stage prostate cancer patients who have failed hormone therapy and at least one round of taxane-based chemotherapy treatment. Currently there is no effective treatment for late-stage prostate cancer, the second leading cause of death in men in the United States. Over one million men in the United States have prostate cancer; approximately 90,000 of these patients have late-stage prostate cancer, resulting in approximately 28,000 deaths each year. There are currently no approved treatments for hormone and chemotherapy refractory prostate cancer and the survival time is estimated to be between 8 and 12 months.
About Harbor BioSciences, Inc.
Harbor BioSciences is a development-stage company with two product candidates in clinical trials: Apoptone (HE3235), in the cohort expansion portion of a Phase I/IIa trial of patients with late-stage prostate cancer, and Triolex®, in a Phase IIa trial in obese type 2 diabetes mellitus patients. Apoptone and Triolex represent the lead candidates from Harbor BioSciences' small molecule platform based on metabolites or synthetic analogs of endogenous steroid hormones. For more information on Harbor BioSciences please visit www.harborbiosciences.com.
This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, our focus on attaining proof-of-concept data for Apoptone in its initial indication of CRPC; and the continuation of treatment, with Apoptone, of men with CRPC for the balance of 2010 under our current Apoptone Phase Ib/IIa Clinical Trial protocol. Any statement included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause Harbor BioSciences' actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in the Company's business, including, but not limited to: the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the Company's capital needs; the Company's ability to obtain additional funding; our ability to obtain regulatory approval for Apoptone (HE3235), Triolex (HE3286) or any other investigational drug candidate; and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, Harbor BioSciences undertakes no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.
APPA having a good day today... Should continue it's upward movement into the PDUFA date in mid-March.
GLTA.
Picked up some SOMX today in the 3.50s... Added some more HRBR.
GLTA.
Picked up some more here @ .46
GLTA!
Ok, copy the image URL ( http://stockcharts.com/c-sc/sc?s=HRBR&p=D&yr=0&mn=9&dy=0&i=p75564701125&r=6287 ), go to "Edit iBox" and under the "Style" tab on the iBox editor, there will be an "Insert/Edit Image" button, click that, paste in the URL, and it'll be in there.
I know how to put a chart like this in the iBox, but I don't know how if it's annotated, b/c it won't keep the annotations: http://stockcharts.com/h-sc/ui?s=HRBR&p=D&yr=0&mn=9&dy=0&id=p90262347660
Looks like this one has some nice upside potential, IMO.
HRBR (Harbor BioSciences, Inc) is on high alert!
Website: http://www.harborbiosciences.com/
Here are some excerpts from last co. PR (before co. name change):
Apoptone (HE3235) is a novel steroid analog of a dihydrotestosterone metabolite that has been found to stimulate cell death (apoptosis) in hormone-dependent prostate tumors. Preliminary results of the company’s ongoing Phase I/IIa clinical trial with Apoptone (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) were presented on November 16, 2009 at the Molecular Targets and Cancer Therapeutics Conference. These data will be updated later in Q1/2010.
Harbor BioSciences is a development-stage company with two product candidates in clinical trials: Apoptone (HE3235), in the cohort expansion portion of a Phase I/IIa trial of patients with late-stage prostate cancer, and Triolex®, in a Phase IIa trial in obese type 2 diabetes mellitus patients. The Triolex study will be completed in Q1/2010, with data expected in Q2/2010. Apoptone and Triolex represent the lead candidates from Harbor BioSciences small molecule platform based on metabolites or synthetic analogs of endogenous steroid hormones.
Do your OWN DD before investing!
GLTA.
Yeah, I agree. Hopefully it can close somewhere in the .80s as well!
GL.
Board title and symbol has been updated!
GL.
Thanks bbb, I've been watching DARA for some time now, bought back in today in the .56s.
GL.
About time for DARA to make a move up. $1 is not too far in the future, IMO.
GLTA.
Everyone please welcome toucan as the new assistant moderator!
GLTA!
Hollis-Eden Announces Name Change to Harbor BioSciences, Inc. and Ticker Symbol Change to 'HRBR'
SAN DIEGO, Feb. 17 /PRNewswire-FirstCall/ -- Hollis-Eden Pharmaceuticals, Inc. (Nasdaq:HEPH - News), today announced that it has changed its name to Harbor BioSciences, Inc. and that its ticker symbol will change from 'HEPH' to 'HRBR' on Thursday, February 18, 2010. The company also received a new CUSIP number (41150V 103) for its common stock.
"We are pleased to begin 2010 with a targeted business strategy focused on attaining proof-of-concept data for Apoptone® in its initial indication of CRPC," stated James Frincke, Ph.D., President and Chief Executive Officer. "Our new name, Harbor BioSciences, reflects our presence in the San Diego area and acknowledges the significant contributions of our dedicated employees here."
Apoptone (HE3235) is a novel steroid analog of a dihydrotestosterone metabolite that has been found to stimulate cell death (apoptosis) in hormone-dependent prostate tumors. Preliminary results of the company's ongoing Phase I/IIa clinical trial with Apoptone (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC) were presented on November 16, 2009 at the Molecular Targets and Cancer Therapeutics Conference. These data will be updated later in Q1/2010.
About Harbor BioSciences, Inc.
Harbor BioSciences is a development-stage company with two product candidates in clinical trials: Apoptone (HE3235), in the cohort expansion portion of a Phase I/IIa trial of patients with late-stage prostate cancer, and Triolex®, in a Phase IIa trial in obese type 2 diabetes mellitus patients. The Triolex study will be completed in Q1/2010, with data expected in Q2/2010. Apoptone and Triolex represent the lead candidates from Harbor BioSciences small molecule platform based on metabolites or synthetic analogs of endogenous steroid hormones. For more information on Harbor BioSciences please visit www.harborbiosciences.com.
This press release contains forward-looking statements within the meaning of the federal securities laws concerning, among other things, our receiving a new ticker symbol; our focus on attaining proof-of-concept data for Apoptone in its initial indication of CRPC; the update of the data from our ongoing Phase I/IIa clinical trial with Apoptone (HE3235) for CRPC; the completion of our Triolex study in Q1/2010; and availability of data from our Triolex study in Q2/2010. Any statement included in this press release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause our actual results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such statements are subject to certain risks and uncertainties inherent in our business, including, but not limited to: the receipt of our new ticker symbol and the timing thereof; the ability to complete preclinical and clinical trials successfully and within specified timelines, if at all; the availability of data within specified timelines; our capital needs; our ability to obtain additional funding; our ability to obtain regulatory approval for Apoptone (HE3235), Triolex (HE3286) or any other investigational drug candidate; and other risks detailed from time to time in our filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, we undertake no obligation to update or revise the information contained in this press release as a result of new information, future events or circumstances arising after the date of this press release.
Potential BioShocker: HRBR
Symbol changing from HEPH to HRBR tomorrow: http://finance.yahoo.com/news/HollisEden-Announces-Name-prnews-649343676.html?x=0&.v=1
Lots of potential, nice low float as well!
GLTA.
Alright! Sorry I haven't gotten to it yet, been really busy! I'll try to work on it some this weekend.
BTW, HEPH will become HRBR tomorrow, according to this recent SEC filing: http://biz.yahoo.com/e/100216/heph8-k.html
GLTA.
GNVC is holding up fairly well pre-market...
GLTA
Nice call on RNN!
Delcath to Initiate Expanded Access Treatment Program for PHP System With Melphalan
Delcath Systems, Inc. (Nasdaq: DCTH), which is testing its proprietary treatment system for metastatic cancers to the liver, announced today that the U.S. Food and Drug Administration ("FDA") will allow the Company to initiate an Expanded Use - Intermediate Size Population protocol for the hepatic arterial infusion of melphalan with venous filtration via the Delcath PHP System(TM) for patients with ocular and cutaneous melanoma metastatic to the liver.
Expanded access programs make certain treatments still being evaluated in late-stage trials available to patients for whom no satisfactory alternatives are available. To grant expanded access, the FDA generally must be satisfied that the potential benefit for the patient justifies the potential risk.
Delcath recently announced that sufficient patient events had occurred in its randomized, multi-center Phase III trial of melphalan for data analysis to begin. Under the Expanded Access Program, the five centers treating the highest number of patients during the Phase III trial may continue to treat patients with metastatic melanoma to the liver while the data is being evaluated. The Expanded Access Program allows patients to be enrolled into the non-randomized study, materially identical to the melphalan arm of the randomized Phase III trial that will be submitted to FDA for a New Drug Application ("NDA") review. Patients treated under the Expanded Access Program will not be included in the data analysis currently underway. Delcath is currently in the final stages of negotiating research contracts with the individual institutions and achieving Institutional Review Board ("IRB") approvals at these five centers. The Company may in the future petition the FDA to add additional centers.
"The Expanded Access Program is terrific news," said Eamonn P. Hobbs, President and CEO of Delcath. "It allows us to offer help to patients with metastatic melanoma to the liver who have no other options at this stage of their disease. And as it is based on available evidence, this development underscores our confidence in the efficacy of high-dose melphalan combined with the Delcath PHP System for this unmet medical need."
Delcath's Phase III trial completed enrollment of 93 patients in October 2009 and the 73rd event required under the study's Special Protocol Assessment prior to the initiation of patient data analysis, was reported on February 4, 2010. The trial's data analysis has begun and involves the initial review by the trial's principal clinical investigators at each of the enrolling centers, additional review by the Company's retained Clinical Research Organization, and then a final review by an independent core lab for verification of results before final statistical results can be attained. Given recently updated schedules by the external reviewers, the completion of this comprehensive review process is now expected to be in April and the Company plans to promptly release key elements as they become available. Submission of the NDA package to the FDA for marketing approval will be made as soon as practically possible, once the data analysis process is completed.
"Our goal is to make sure that all data from the trial is thoroughly reviewed before any release and we fully support the comprehensive process underway. We remain highly confident that the trial's data will meet the trial's primary endpoint, and our confidence has been further buoyed by the FDA's acknowledgement of an expanded access program," Mr. Hobbs concluded.
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical technology company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of primary and metastatic liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer agents to the liver while controlling the systemic exposure of those agents. In addition to the Phase III metastatic melanoma study, the Company is currently conducting trials to treat other forms of tumor metastases to the liver. The Company maintains a broad intellectual property portfolio on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at www.delcath.com.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to successfully complete Phase III clinical trials and secure regulatory approval of our current or future drug-delivery system and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
SOURCE Delcath Systems, Inc.
Nice buy...
GL.
According to the AP Pharma website, it's can potentially enter into a $1B CINV market (www.appharma.com). I've heard estimates that it could potentially get as much as $400M. But a more conservative estimate would be $100M-200M, IMO.
GL.
Good point. May be right, IMO.
GL.
Delcath Signs First Partner Agreement in Asia
Chi-Fu Trading Co., Ltd. Becomes Exclusive Distributor of The Delcath PHP System In Taiwan
Minimum Value To Delcath Expected To Be Approximately $10 Million
NEW YORK, Feb. 9 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. (Nasdaq: DCTH), a medical technology company testing its proprietary treatment system for primary and metastatic cancers to the liver, announced today the signing of its first research, distribution, sales and marketing agreement for its Percutaneous Hepatic Perfusion (PHP) System (the Delcath PHP Systemâ„¢). The agreement grants Chi-Fu Trading Co., Ltd. the exclusive right to market and sell the Delcath PHP System in Taiwan for hepatic malignancies and infectious disease upon Taiwan Food and Drug Administration (TFDA) approval, and any other approved use, with a conditional option for Singapore.
Under terms of the agreement, Chi-Fu will fund and manage clinical studies at up to four sites to gather data for submission to Taiwan government regulatory agencies for approval. Any regulatory filings will be in the name of Delcath Systems, Inc. For the clinical studies, Chi-Fu will purchase, at a discount, Delcath PHP Systems to treat up to 200 patients with hepatic cancer. Any additional systems required will be sold at a confidential distributor price. It is intended that at least two of the clinical study sites will become reference sites when the studies are completed.
Under the terms of the agreement, Delcath is to receive $1 million in milestone payments, comprised of $300,000 upon execution of the agreement and the balance upon receipt of the CE Mark and upon receipt of FDA approval. In addition Chi-Fu will be contractually committed to purchase a minimum number of systems annually during the term of the agreement, commencing when commercial sales begin in Taiwan. The term of the agreement extends for five years from the month when TFDA approval is received. The total value of the agreement to Delcath assuming receipt of the necessary approvals is estimated to be at least $10 million.
The terms of the agreement do not include Delcath providing any drugs used with the Delcath PHP System to Chi-Fu. If during the term of this agreement, other indications for the Delcath PHP System are approved by the TFDA, Chi-Fu will have the right to distribute the Delcath PHP System in Taiwan for those indications as well.
According to Eamonn P. Hobbs, CEO of Delcath Systems, "This agreement is an important first step in bringing our proprietary technology to Asia, where the incidence of liver cancer and related hepatic disease is a major health issue and a leading cause of death. In Taiwan, malignant neoplasms represent 29% of all deaths and as such, we view Taiwan as an excellent opportunity to seek approval to demonstrate the ability of the Delcath PHP System to help patients and improve outcomes. In addition, we look forward to working with Chi-Fu to identify additional indications for our targeted drug delivery platform technology. We believe the Chi-Fu agreement is a significant validation for the Delcath PHP System and we are continuing to pursue additional strategic partnerships to address other key Asian markets," Mr. Hobbs concluded.
According to Wayne Hsu, Managing Director of Chi-Fu and board member of Shing-Er Lii Hsu memorial foundation for the research of medical treatments, "Becoming the exclusive distributor in Taiwan of the Delcath PHP System is key in helping Chi-Fu and the foundation to achieve a number of its goals. Among these goals is our desire to bring innovative technology to the Taiwan medical community, to expand our current product offerings in the oncology segment, and lastly and most importantly, to support the government healthcare system efforts to potentially reduce the death rate and improve the quality of life for hepatic cancer patients. We further see this as the first step in building a strong partnership with Delcath as their platform technology is adapted to treat new cancers and other disease indications in the future."
About Delcath Systems, Inc.
Delcath Systems, Inc. is a medical device company specializing in cancer treatment. The Company is testing a proprietary, patented drug delivery system for the treatment of primary and metastatic liver cancers. Delcath's novel drug delivery platform is testing the delivery of ultra-high doses of anti-cancer drugs to the liver while preventing these high doses of drug from entering the patient's bloodstream. Delcath is currently conducting a Phase III clinical trial and multi-arm Phase II clinical trial of the Delcath PHP System with melphalan in patients with liver cancers. The Company maintains a broad intellectual property portfolio on a worldwide basis including the U.S., Europe, Asia and Canada. For more information, please visit the Company's website at www.delcath.com.
About Chi-Fu Trading Co., Ltd.
Chi-Fu is a private company that has been serving the medical community in Taiwan since 1930. As an importer and distributor of medical devices, medical equipment, pharmaceuticals, consumables and biotechnology products, Chi-Fu focuses its sales activities on hospitals and clinics, which represent 79% of their revenues. Other segments include drug stores and wholesalers. Among the companies that Chi-Fu represents are AstraZeneca, Sanofi-Aventis, and Bausch & Lomb . In 2009 their revenues exceeded $60 million(USD). Chi-Fu is headquartered in Taipei City, with sales representation throughout Taiwan.
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to our ability to obtain TFDA approval and other necessary regulatory approvals, including the approval of the U.S. Food and Drug Administration of the Delcath PHP System and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission, including our recently filed prospectus supplement filed with the Securities and Exchange Commission on November 13, 2009 and our most recently filed Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for our fiscal year ended December 31, 2008. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.
Delcath PHP Systemâ„¢ is a trademark of Delcath Systems, Inc. All rights reserved.
Welcome zigzagman as a new assistant moderator!
I might jump back in again if it gets back in the low .70s. But as for now I wanted to have some free cash in case APPA or GNVC presents a nice buying opportunity.
New 52wk high @ $1.97 :)
GLTY!