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GET IN NOW ..RALLLYYYY
Nice Presentation
http://files.shareholder.com/downloads/CLN/602406864x0x346156/27DBABE5-B30F-424A-82E1-3DD9A21A0727/January_2010.pdf
Good News ....
Celsion Plans to Launch Phase II Program to Study ThermoDox(R) in Combination with RFA for Colorectal Liver Metastases
COLUMBIA, Md., March 1 /PRNewswire-FirstCall/ --
Celsion Corporation today announced that it will initiate a Randomized Phase II Study of Lyso-Thermosensitive Liposomal Doxorubicin (ThermoDox®) and Radiofrequency Ablation (RFA) for Colorectal Liver Metastases (CRLM). Dr. Steven K. Libutti, Professor and Vice Chairman, Department of Surgery and Director of the Montefiore-Einstein Center for Cancer Care and Albert Einstein College of Medicine in New York City, will serve as Principal Investigator for the study. In addition to Montefiore Medical Center, at least 2 other leading research institutions from North America and the Asia Pacific region (including Japan) will be included in the Phase II study, which is expected to commence in the second half of 2010. The study is meant to address the growing unmet medical need of colorectal liver metastases, which is globally prevalent and is currently treated by radiofrequency ablation.
"Celsion Corporation first began studying ThermoDox in combination with RFA for liver metastases in a Phase I safety study of 24-patients, 15 of which had liver metastases from 9 primary sites, including CRLM," said Michael Tardugno, President and CEO of Celsion. "The safety experience and dose response relationship we witnessed in the Phase I study was evident in both primary and metastatic tumors. Building upon this data, we have made the decision to pursue a randomized Phase II study. CRLM is an indication which we believe has a large addressable market, and we expect that CRLM will be a label extension to hepatocellular carcinoma, increasing the value of ThermoDox." "Having previously studied ThermoDox and completed the Phase I study, I felt the CRLM indication must be further investigated," said Dr. Steven K. Libutti, a prominent expert in treating liver cancer metastases. "There is a large unaddressed population here in North America, and I believe ThermoDox may play a role in treating liver metastases, particularly for larger tumors where survival rates are poor. We believe we are well positioned to conduct this study given the outstanding clinicians and our vast experience in clinical trial research at the Montefiore-Einstein Center for Cancer Care." Investor Contact
Chart looks very BULLISH
Still very cheap here ...
CLSN IS ON THE MOVE ::::::::::::::::::
Big US-PartnerShip is coming very soon ....
Celsion (CLSN)
Market Cap: 38 Mio$
Cash: 14,1 Mio$
Price: 3,15 $
Shares Out: 12,1 M
Huge Pipeline
http://www.celsion.com/pipeline.cfm
"We continue to make substantive progress in our Phase III HEAT trial for ThermoDox with over 45% of the 600 patients now enrolled in the study," said Michael Tardugno, President and CEO of Celsion. "With the recent addition of China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and Italy, we expect enrollment completion within the next 2 quarters. We have achieved our goal of opening enrollment at 60 clinical trial sites world-wide, and we anticipate initiating the trial at an additional 10 sites by the end of this month. Additionally, our pivotal Phase recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a sufficient number of patients in the Phase I portion to warrant a dose escalation review by the DSMB. Assuming there will be no adverse events suggesting dose limiting toxicity, the Dignity Study may be allowed to increase dosage to the therapeutic dose as early as March of this year."
Data Monitoring Committee Recommends Continuation of Celsion's Phase III ThermoDox(R) Study for Primary Liver Cancer
270 patients treated in Phase III trial at 60 sites in 11 countries
COLUMBIA, Md., Feb 10, 2010 /PRNewswire via COMTEX News Network/ -- Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox(R) clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.
The DMC for the HEAT study is comprised of an independent group of medical and scientific experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DMC reviews safety data at regular intervals with the mandate to ensure patient safety and monitor the quality and overall conduct of the study. The study design and statistical plan for the Phase III ThermoDox trial also incorporates a pre-planned interim efficacy analysis by the DMC after patient enrollment is complete, with the intent to stop the study if there is overwhelming evidence of treatment benefit or an extremely low probability of treatment success.
"We are pleased that the DMC has recommended continuation of the study based on its review of the safety data," stated Michael H. Tardugno, President and Chief Executive Officer of Celsion. "We currently have 60 sites enrolling patients in 11 countries and plan to have 70 sites with patients by the end of February. With recent acceleration in patient recruitment, and the study now nearly 50% enrolled, we project that the trial will be fully enrolled within the next two quarters."
Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival.
Big US-PartnerShip is coming soon ....
Cheapest stock out there ....
Celsion (CLSN)
Market Cap: 36 Mio$
Cash: 14,1 Mio$
Price: 3,00$
Shares Out: 12,1 M
Pipeline
http://www.celsion.com/pipeline.cfm
"We continue to make substantive progress in our Phase III HEAT trial for ThermoDox with over 45% of the 600 patients now enrolled in the study," said Michael Tardugno, President and CEO of Celsion. "With the recent addition of China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and Italy, we expect enrollment completion within the next 2 quarters. We have achieved our goal of opening enrollment at 60 clinical trial sites world-wide, and we anticipate initiating the trial at an additional 10 sites by the end of this month. Additionally, our pivotal Phase recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a sufficient number of patients in the Phase I portion to warrant a dose escalation review by the DSMB. Assuming there will be no adverse events suggesting dose limiting toxicity, the Dignity Study may be allowed to increase dosage to the therapeutic dose as early as March of this year."
Data Monitoring Committee Recommends Continuation of Celsion's Phase III ThermoDox(R) Study for Primary Liver Cancer
270 patients treated in Phase III trial at 60 sites in 11 countries
COLUMBIA, Md., Feb 10, 2010 /PRNewswire via COMTEX News Network/ -- Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox(R) clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.
The DMC for the HEAT study is comprised of an independent group of medical and scientific experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DMC reviews safety data at regular intervals with the mandate to ensure patient safety and monitor the quality and overall conduct of the study. The study design and statistical plan for the Phase III ThermoDox trial also incorporates a pre-planned interim efficacy analysis by the DMC after patient enrollment is complete, with the intent to stop the study if there is overwhelming evidence of treatment benefit or an extremely low probability of treatment success.
"We are pleased that the DMC has recommended continuation of the study based on its review of the safety data," stated Michael H. Tardugno, President and Chief Executive Officer of Celsion. "We currently have 60 sites enrolling patients in 11 countries and plan to have 70 sites with patients by the end of February. With recent acceleration in patient recruitment, and the study now nearly 50% enrolled, we project that the trial will be fully enrolled within the next two quarters."
Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival.
We could see4$ by Weekend ...
CLSN IS THE NEXT HOT STOCK !!
Celsion's Technology Is the Focus of 6.4 Million EUR 'HIFU-CHEM' Program To Study ThermoDox(R) and MRI-guided HIFU
Project Will Focus on Early Development and Investigate Treatment Options for Two Indications: Liver and Bone Metastases
http://finance.yahoo.com/news/Celsions-Technology-Is-the-prnews-1680791093.html?x=0&.v=1
Celsion (CLSN)
Market Cap: 35 Mio$
Cash: 14,1 Mio$
Price: 2,90$
Shares Out: 12,1 M
Insider
http://finance.yahoo.com/q/it?s=CLSN
Data Monitoring Committee Recommends Continuation of Celsion's
Phase III ThermoDox(R) Study for Primary Liver Cancer
http://www.celsion.com/releasedetail.cfm?ReleaseID=444013
News
http://www.celsion.com/releases.cfm
Pipeline
http://www.celsion.com/images/Pipeline-Slide-012009.jpg
CEO Letter August 2009
http://www.celsion.com/letter.cfm
Celsion Corporation Announces Exclusive Japan License Agreement with Yakult Honsha for ThermoDox(R)
Dec 15, 2008
http://www.celsion.com/releasedetail.cfm?ReleaseID=354312
BST-CarGel PIII Results soon . This stock is flying under Radar ..
Positive Final- Data will push this stock over 1$ !!
BioSyntech (BSY.TO)
Market Cap : 10,5 Mio $
Price : 0,10,5 $
BioSyntech Reports Positive Results from Pivotal Trial for BST-CarGel® Cartilage Repair Device
June 17, 2009
http://biosyntech.com/en/investors/press.aspx?ID=111
BST-CarGel
http://biosyntech.com/en/expertise/orthopedics/?BST=CarGel
Insider
http://canadianinsider.com/coReport/allTransactions.php?ticker=bsy
Market Potential
BST-CarGel®
Not yet approved by Health Canada, the FDA or the European authorities
BST-CarGel® is aimed at treating focalized cartilage lesions, either from trauma (sports injury or accident) or from secondary osteoarthritis (OA) degeneration.
Arthroscopic view of
a cartlage lesion
The various surgical techniques (microfactures, mosaicplasty, autologous chondrocyte implantation) currently used all have their drawbacks including complicated or multiple surgeries, high cost and/or poor outcomes.
Orthopedic surgeons perform 1.6 million of knee arthroscopic procedures each year in the USA. Cartilage lesions are found in a large number of these procedures.
Additionally, a number of patients too young for arthroplasty, suffering from secondary osteoarthritic focal lesions due to previous trauma, body weight, mis-alignment of the joint or from a previous meniscal surgery, may be good candidates for BST-CarGel®. Osteoarthritis affects around 10% of the population. In the USA alone, it represents 21 million people, out of whom around 65% suffer from OA of the knee.
Cartilage lesions in other joints such as the hip, ankle and the shoulder could potentially benefit from BST-CarGel®.
BST-CarGel® will be more cost-effective than the overly-expensive cell-based therapies to address the challenges of the various healthcare systems around the worl
BNC.TO is the next Dendreon !!!!!!!!!!!
Urocidin (Bladder cancer) PIII results in 2Q 2010
Positive Results will push this stock to 5$ ++ ....Please do your own DD !!
Bioniche Life Science (BNC.TO)
Market Cap: 81 Mio C$
Cash: 30 Mio C$
Price: 0,94 C$
Bioniche shares jump 34% on Endo taking up global rights
February 12, 2010 by biotuesday
http://biotuesday.ca/2010/02/12/bioniche-shares-jump-34-on-endo-taking-up-global-rights/
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III NMI bladder cancer trial
2011 Belleville, ON vaccine manufacturing centre operational
Insider activity
http://canadianinsider.com/coReport/allTransactions.php?ticker=bnc
Urocidin (Bladder Cancer) PII Results
http://www.medicalnewstoday.com/articles/139517.php
1,50 $ TGT by Haywood
http://www.haywood.com/pdffiles/BNCJul142009.pdf
SECTOR OUTPERFORM; Target: $1.50 Risk: SPECULATIVE
Partnership Agreement Puts BNC Back on Track
ALPHA: We see significant upside to investors. BNC's share price
reflects a value for the Animal Health division only - that is at 5x
2009 EBITDA or
.50/shr. We note the US$20M upfront from the Endo
agreement is worth ~
.25/shr alone. We disagree with the market that
the Human Health division with Urocidin is currently worth zero to BNC and investors.
Fantastic News out for Bioniche !!!!
Still very cheap here ...
http://finance.yahoo.com/news/Bioniche-Achieves-Two-cnw-1101331284.html?x=0
Bioniche Achieves Two Additional Milestones Under Licensing Agreement; Endo Takes up Global Rights
Press Release Source: Bioniche Life Sciences Inc. On Friday February 12, 2010, 10:00 am EST
- Payment to Bioniche of US$8M by Endo Pharmaceuticals -
Still very cheap here ...
GLTA
1,50-2$
GLTA
Approval this Week ..RALLYYYYYYYYY
Get in now before its too late !!!!
Cytomedix (AMEX : GTF )
Market Cap : 18,8 Mio$
Price : 0,50 $
Shares Out : 37,3 M
On August 7, 2009, Cytomedix, Inc. (NYSE AMEX:GTF) announced that it has submitted to, the United Sates of America’s toughest regulator, the Food and Drug Administration (FDA) a 510(K) for its AutoloGel™ Platelet Separation System. The 510(K) submission was made to obtain pre market approval from the FDA. We anticipate they will get a response from the FDA after 6 months, i.e. on or around February 7, 2010. However, the FDA may not give its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.
GTF =Approval this Week !!!!
Get in now before its too late !!!!
Cytomedix (AMEX : GTF )
Market Cap : 18,8 Mio$
Price : 0,50 $
Shares Out : 37,3 M
On August 7, 2009, Cytomedix, Inc. (NYSE AMEX:GTF) announced that it has submitted to, the United Sates of America’s toughest regulator, the Food and Drug Administration (FDA) a 510(K) for its AutoloGel™ Platelet Separation System. The 510(K) submission was made to obtain pre market approval from the FDA. We anticipate they will get a response from the FDA after 6 months, i.e. on or around February 7, 2010. However, the FDA may not give its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.
Update by Union-Securities ..1,90$ Tgt
http://www.union-securities.com/CMResearchFiles/1_61_Intelgenx%20%28IGX%20v%29%20Bulletin%20Jan%2025%202010.pdf
Last chance to get in under 2$
US approval..NEXT WEEK
Up 10% today ...
http://investorshub.advfn.com/boards/board.aspx?board_id=13856
This is a real sleeper !!!! Please do your own Research .
Intelgenx Technologies (IGXT.OB)
MarketCap : 22 Mio US$
Price : 0,61 $
Shares Out : 33 M
Check out their fantastic Pipeline !
http://www.intelgenx.com/products/pipeline.html
IntelGenx Corp. (TSX-V: IGX)(OTC.BB: IGXT) ("IntelGenx") today announced that the New Drug Application filing for their antidepressant CPI-300 has been accepted by the U.S. Food and Drug Administration (FDA) for standard review. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, IntelGenx expects the FDA will complete its review or otherwise respond to the NDA by February 6, 2010.
US approval NEXT WEEK
Load up the truck ...Approval will push this stock to 3$ +
GLTA
US approval + PartnerShip = 5$ ++
US approval for Once a day Tramadol + PartnerShip any day now ...
Do your own DD!!!!
Cipher Pharma (DND.TO) (CPHMF.PK) << Canadian Stock !!!
Market Cap : 38 Mio$
Cash: 9,3 Mio$
Price : 1,70 $
Shares Out : 24 M
Pipeline
http://cipherpharma.com/web/main.cfm?docID=11
Cipher secures summary judgment in the company's favour in pending patent litigation involving CIP-TRAMADOL ER
1/4/2010 7:00 AM - Canada NewsWire
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn_newsreleases.asp%3Fsymbol%3DT.DND%26newsid%3D7580687
Great Article .. A must read
http://biotuesday.ca/2010/01/05/cipher-plans-to-license-in-new-drug-this-year/
Presentation
http://cipherpharma.com/downloads/DND_Presentation_BIO_Oct2009.pdf
RALLLLLYYYYYYYYYYYYYYYYYYYYYY
Market Cap of 33 M$ is still wayyyy undervalued
US approval within 5 weeks eom
RAALLLYYYY ..PIII Results Soon !!!!!
http://ih.advfn.com/p.php?pid=staticchart&s=T%5EBNC&p=0&t=8
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III NMI bladder cancer trial
23
2011 Belleville, ON vaccine manufacturing centre operational
Phase III Data will be positive
See you at 7$+ by year end !!! Ralllyyyyyyyyy
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn_overview.asp%3Fsymbol%3DT.BNC%26table%3DLIST
We could see 4-5$ with US approval !!!
No risk here ...
Great Article .. A must read
http://biotuesday.ca/2010/01/05/cipher-plans-to-license-in-new-drug-this-year/
Market Cap of 25 M$ is wayyyy undervalued
Great Article .. A must read
http://biotuesday.ca/2010/01/05/cipher-plans-to-license-in-new-drug-this-year/
Up Up wooohooo
Approval and PartnerShip is coming very very soon ....
New Interview with CEO Mitchell
http://www.stockgoodies.com/music/gallery/PMBS-CEO-Mr-Russell-Mitchell
Great news !!!!!!!!!!!!!!1
IntelGenx Receives Notice of Allowance for Bupropion Patent
marketwire
Press Release Source: IntelGenx Corp. On Thursday January 21, 2010, 6:00 am EST
SAINT LAURENT, QUEBEC--(Marketwire - 01/21/10) - IntelGenx Corp. (TSX-V:IGX - News) (OTC.BB:IGXT - News) ("IntelGenx") today announced that the U.S. Patent and Trademark Office ("USPTO") has issued a formal Notice of Allowance for a key patent application protecting IntelGenx's CPI-300, a novel, high strength formulation of bupropion hydrochloride ("HCl"), the active ingredient in Wellbutrin XL?.
The patent entitled "Sustained-Release Bupropion and Bupropion/Mecamylamine Tablets" discloses the formulation of pharmaceutical tablets containing sustained-release granules of bupropion HCl distributed in a sustained-release matrix. The patent will ultimately provide broad protection for CPI-300 until 2027 (twenty years from the filing date) and upon regulatory approval be listed in the U.S. Food and Drug Administration's ("FDA") Orange Book.
"This Notice of Allowance demonstrates IntelGenx's ability to successfully develop and patent novel products through our proprietary VersaTab technology," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "We believe CPI-300 could fill a significant need in the lucrative bupropion market. With the potential to be the first and only single-tablet high-dose form of bupropion HCl on the market, we believe CPI-300's convenience and patient compliance advantages could make it a very successful brand."
IntelGenx is currently awaiting approval from the FDA for its New Drug Application ("NDA") for CPI-300. IntelGenx and Cary Pharmaceuticals entered into a Collaborative Agreement in November 2007 to jointly develop and commercialize CPI-300 using IntelGenx's proprietary oral VersaTab delivery technology. Cary Pharmaceuticals serves as the NDA applicant for CPI-300.
About IntelGenx Corp.:
IntelGenx Corp. is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx's research and development pipeline includes products for the treatment of pain, hypertension, osteoarthritis and depressive disorders. More information is available about the company at www.intelgenx.com.
Forward Looking Statements:
This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K for the fiscal year ended December 31, 2008, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.
Approval is Comingggggggg
The Cipher Judgment terminates any further stay of Cipher's NDA under the applicable provisions of the Hatch-Waxman Act.
US approval for Once a day Tramadol(Best in Class) + PartnerShip any day now . This stock is an unknown gem ...
Up 26%
http://ih.advfn.com/p.php?pid=webchart&cb=1264014227&symbol=T^DND&period=0&size=19&volume=1
CIPHER WINS PATENT LITIGATION = 100% US APPROVAL VERY SOON !!!
Cipher secures summary judgment in the company's favour in pending patent litigation involving CIP-TRAMADOL ER
1/4/2010 7:00 AM - Canada NewsWire
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn_newsreleases.asp%3Fsymbol%3DT.DND%26newsid%3D7580687
Cipher Pharma (DND.TO) (CPHMF.PK) << Canadian Stock !!!
Market Cap : 17 Mio$
Cash : 9 Mio$
Price : 0,71 $
Shares Out : 24 M
Pipeline
http://cipherpharma.com/web/main.cfm?docID=11
Great Article .. A must read
http://biotuesday.ca/2010/01/05/cipher-plans-to-license-in-new-drug-this-year/
Presentation
http://cipherpharma.com/downloads/DND_Presentation_BIO_Oct2009.pdf
Positive Stroke data = 3$++ Tgt !!!!
Hold on to your shares ....
Stem Cell Therapeutics (SSS.V)
Market Cap 41 Mio $
Price 0,30 $
UPCOMING MILESTONES
Complete recruiting for modified REGENESIS Phase IIb clinical stroke trial end of Q1 10
Top-line read of modified REGENESIS Phase IIb stroke trial data
end of Q2 10
Initiate and enrol patients in a Phase IIa clinical study for traumatic brain injury H1 10
Initiate clinical Proof-of-Concept study for multiple sclerosis 2010
RPTP is on the move ....
Still a big opportunity here ..
Great news out for EMIS...
http://finance.yahoo.com/news/Novo-Nordisk-Starts-Phase-I-bw-158662610.html?x=0&.v=1
Novo Nordisk Starts Phase I Trial with Long-Acting Oral GLP-1 Analogue
Emisphere earns $2 million milestone payment
Press Release Source: Emisphere Technologies, Inc. On Wednesday January 13, 2010, 2:30 am EST
CEDAR KNOLLS, N.J.--(BUSINESS WIRE)--Emisphere Technologies, Inc. today announced that Novo Nordisk has initiated its first Phase I clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a $2 million payment to Emisphere, whose proprietary Eligen® Technology is used in the formulation of NN9924.
GLP-1 (Glucagon-Like Peptide-1) is a natural hormone involved in controlling blood sugar levels. It stimulates the release of insulin only when blood sugar levels become too high. GLP-1 secretion is often impaired in people with Type 2 Diabetes.
The aim of this trial, which is being conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. The trial will enroll approximately 155 individuals and results from the trial are expected in 2011.
There are many challenges in developing an oral formulation of GLP-1, in particular obtaining adequate bioavailability. NN9924 addresses some of these key challenges by utilizing Emisphere’s Eligen® Technology to facilitate absorption from the gut.
“We still have a long road with many challenges ahead of us before an insulin pill or a GLP-1 pill becomes a reality,” says Peter Kurtzhals, Senior Vice President and Head of Diabetes Research at Novo Nordisk. “But with the progress we have made so far I am convinced it is only a matter of time.”
Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies, says, “This milestone reflects a major achievement for our program and partnership with Novo Nordisk and is one small but significant step forward in the development of a successful treatment for Type 2 Diabetes. As a company, we are extremely encouraged by the progress to date and look forward to the future and the potential benefits this program may bring to the millions of patients being treated for this disease.”
In June 2008, Novo Nordisk and Emisphere entered into a development and license agreement to develop and commercialize oral formulations of Novo Nordisk’s proprietary GLP-1 analogues, using Emisphere’s Eligen® Technology. This is the first development milestone achieved by Emisphere under this agreement.
Great news out for EMIS...
http://finance.yahoo.com/news/Novo-Nordisk-Starts-Phase-I-bw-158662610.html?x=0&.v=1
Novo Nordisk Starts Phase I Trial with Long-Acting Oral GLP-1 Analogue
Emisphere earns $2 million milestone payment
Press Release Source: Emisphere Technologies, Inc. On Wednesday January 13, 2010, 2:30 am EST
CEDAR KNOLLS, N.J.--(BUSINESS WIRE)--Emisphere Technologies, Inc. today announced that Novo Nordisk has initiated its first Phase I clinical trial with a long-acting oral GLP-1 analogue (NN9924). This milestone releases a $2 million payment to Emisphere, whose proprietary Eligen® Technology is used in the formulation of NN9924.
GLP-1 (Glucagon-Like Peptide-1) is a natural hormone involved in controlling blood sugar levels. It stimulates the release of insulin only when blood sugar levels become too high. GLP-1 secretion is often impaired in people with Type 2 Diabetes.
The aim of this trial, which is being conducted in the UK, is to investigate the safety, tolerability and bioavailability of NN9924 in healthy volunteers. The trial will enroll approximately 155 individuals and results from the trial are expected in 2011.
There are many challenges in developing an oral formulation of GLP-1, in particular obtaining adequate bioavailability. NN9924 addresses some of these key challenges by utilizing Emisphere’s Eligen® Technology to facilitate absorption from the gut.
“We still have a long road with many challenges ahead of us before an insulin pill or a GLP-1 pill becomes a reality,” says Peter Kurtzhals, Senior Vice President and Head of Diabetes Research at Novo Nordisk. “But with the progress we have made so far I am convinced it is only a matter of time.”
Michael V. Novinski, President and Chief Executive Officer, Emisphere Technologies, says, “This milestone reflects a major achievement for our program and partnership with Novo Nordisk and is one small but significant step forward in the development of a successful treatment for Type 2 Diabetes. As a company, we are extremely encouraged by the progress to date and look forward to the future and the potential benefits this program may bring to the millions of patients being treated for this disease.”
In June 2008, Novo Nordisk and Emisphere entered into a development and license agreement to develop and commercialize oral formulations of Novo Nordisk’s proprietary GLP-1 analogues, using Emisphere’s Eligen® Technology. This is the first development milestone achieved by Emisphere under this agreement.
1,50 $ TGT by Haywood
http://www.haywood.com/pdffiles/BNCJul142009.pdf
SECTOR OUTPERFORM; Target: (+$0.20) $1.50; Risk: SPECULATIVE
Partnership Agreement Puts BNC Back on Track
ALPHA: We see significant upside to investors. BNC's share price
reflects a value for the Animal Health division only - that is at 5x
2009 EBITDA or $0.50/shr. We note the US$20M upfront from the Endo
agreement is worth ~$0.25/shr alone. We disagree with the market that
the Human Health division with Urocidin is currently worth zero to BNC
and investors.
Insider activity
http://canadianinsider.com/coReport/allTransactions.php?ticker=bnc
BNC is up 17%
BNC has 10 bagger potential ...
http://ih.advfn.com/p.php?pid=staticchart&s=T%5EBNC&p=0&t=8
The best and cheapest canadian biotech company ...
Bioniche will explode very soon .....
Bioniche ...BNC.TO
Market Cap 48 M$
Cash 20 M$
Price 0,56 $
Presentation
http://www.bioniche.com/pdf/blsi-agm-11-05-09.pdf
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III NMI bladder cancer trial
23
2011 Belleville, ON vaccine manufacturing centre operational
Big Partnership coming soon
REASONS TO INVEST IN STEM CELL THERAPEUTICS
• Lead program adressing a major unmet need with a large commercial potential
- Stroke is the leading cause of serious, long-term disability 1
- On average, a stroke occurs every 40 seconds 1
- Only treatments available: tPA (<4% of ischemic patients treated) and aspirin
• Current lack of effective treatment for reducing and repairing damage caused by stroke
• Shortened path to regulatory approval, decreased development risk and cost due to current FDA approval status of the drugs used in NTx®-265
• Attractive therapeutic window of NTx®-265 (within 24-48hours post stroke) and easy administration method (avoid the need for invasive brain surgery)
• Encouraging results from BETAS Phase IIa stroke trial demonstrated positive drug related effects on visual, motor and cognitive recovery in patients who suffered acute ischemic stroke.
• Additional indications being explored, traumatic brain injury (TBI) and multiple sclerosis (MS); also representing major unmet needs and large commercial potential
• Clinical programs with strong partnering potential
• Issued and pending patents protecting SCT's extensive intellectual property portfolio
TGT 6,56 $ by Vista
Raptor Pharmaceutical Corp. (RPTP)
Target Price: $6.56
Raptor announced positive findings from the completed treatment phase of its open-label Phase 2a clinical trial of delayed-release cysteamine bitartrate ("DR Cysteamine") in adolescent patients with non-alcoholic steatohepatitis ("NASH"), a progressive form of liver disease believed to affect 2% to 5% of the U.S. population.
the completion of the initial six-month treatment phase, the study achieved the primary endpoint: mean blood levels of alanine aminotransferase ("ALT"), a common biomarker for NASH, were reduced by over 50%. Additionally, over half of the study participants had achieved normalized ALT levels by the end of the treatment phase. There are no currently approved drug therapies for NASH. These interim results have established proof-of-concept and support further clinical development of DR Cysteamine in NASH.
The Company also announced that data from a clinical trial of NGX426, the Company's orally administered non-opioid, AMPA/kainate antagonist, will be presented at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain, to be held November 20-21, 2009 in San Francisco. The objective of the single center, double-blind, randomized study conducted by Mark Wallace, M.D., Professor of Clinical Anesthesiology at the Center for Pain Medicine of the University of California at San Diego, was to demonstrate that the orally administered prodrug NGX426, maintains the analgesic effect previously shown for the active moiety tezampanel. Using a cross-over design, a total of 18 study subjects received single doses of 90 mg of NGX426, 150 mg of NGX426 or placebo in each of three treatment periods. Pain was induced by injecting 250 ug of capsaicin between layers of skin in the forearm at 30 minutes and 120 minutes after dosing. This is yet another valuable asset in Raptor’s clinical pipeline. The Company plans to continue to explore options with NGX426 in the treatment of pain, which potentially include spinning-out or partnering this program to ensure that shareholders receive the maximum value from this potentially groundbreaking drug.
In addition, Raptor will potentially have their cystinosis drug on the market in 1H 2011. The fact that Raptor is potentially 18 months away from producing revenues represents a significant opportunity for investors and why we believe Raptor’s share price will increase substantially from current levels. Raptor currently has a balanced pipeline of clinical and preclinical programs. The Company is currently involved in four Phase II clinical programs. The Company’s clinical trials address indications representing large markets worldwide: ALDH2 deficiency and NASH; along with Orphan Indications which typically have a shorter development cycle: cystinosis, and Huntington’s Disease. ALDH2 deficiency and Huntington’s Disease each represent potentially billion dollar markets.
Good News ...
11.01.2010 12:31
Raptor Pharmaceutical Corp. Announces Publication of Results from Phase 2a Trial of DR Cysteamine for Treatment of Cystinosis / Potential to Improve Treatment with Less Frequent Administration and Better Tolerability
NOVATO, Calif., Jan. 11 /PRNewswire-FirstCall/ -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") , today announced the publication of results from a Phase 2a clinical trial of a prototype formulation of its proprietary delayed-release cysteamine bitartrate ("DR Cysteamine") in patients with nephropathic cystinosis ("cystinosis"). Ranjan Dohil, M.D., Professor of Pediatrics at the University of California, San Diego, was lead author of the study to be published in the Journal of Pediatrics and available online at http://www.ncbi.nlm.nih.gov/pubmed/19775699?itool=EntrezSystem2.PEntrez.Pubmed .Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=1.
(Logo: http://www.newscom.com/cgi-bin/prnh/20071022/NYM074LOGO )
The Phase 2a study demonstrated proof-of-concept for DR Cysteamine, which is Raptor's proprietary, delayed-release, enteric-coated microbead formulation of immediate release cysteamine bitartrate contained in a gelatin capsule. Immediate-release cysteamine bitartrate ("IR Cysteamine") is the current standard of care for treating cystinosis. The results indicated that when given twice daily, the prototype DR Cysteamine formulation was effective at maintaining low white blood cell ("WBC") cystine levels (<2 nmol half-cystine/mg protein) in subjects with cystinosis. Results also indicated that the prototype DR Cysteamine effectively maintained trough WBC cystine levels within a satisfactory range when patients received approximately 60% of the previous total daily dose of IR Cysteamine.
Dr. Dohil stated, "We are seeking to improve tolerability and reduce dosing frequency requirements of IR Cysteamine which have been documented challenges for cystinosis patients, leading to widely reported instances of poor treatment compliance. We believe the results of the Phase 2a study bring us significantly closer to a potential treatment solution for cystinosis patients. The results from our trial indicate prototype delayed-release cysteamine formulation lead to improved tolerability and efficacy when administered twice-daily and at a lower total daily dose than IR Cysteamine. Based on these results, I believe that Raptor's final DR Cysteamine formulation has the potential to improve compliance and long-term treatment outcomes for cystinosis patients."
Based on these Phase 2a results, Raptor conducted a Phase 2b clinical trial using its final commercial formulation of DR Cysteamine and recently announced the following top-line Phase 2b results: DR Cysteamine demonstrated improved tolerability and the potential to reduce total daily dosage and administration frequency compared to IR Cysteamine.
-- Pharmacokinetic evaluation showed that DR Cysteamine had a terminal half-life more than three times longer than the terminal half-life of IR Cysteamine. -- Twice-daily DR Cysteamine may achieve the same pharmacodynamic result while using a total daily dose 30% lower than IR Cysteamine administered four times daily. -- No adverse events recorded during the clinical trial were determined by the principal investigator to be possibly or probably related to DR Cysteamine. Nine adverse events recorded in the clinical trial were determined to be possibly or probably related to IR Cysteamine. -- The proprietary, final formulation of DR Cysteamine confirmed earlier clinical trials conducted by Dr. Dohil using an enteric-coated prototype formulation of cysteamine bitartrate, which was funded by the Cystinosis Research Foundation ("CRF").
During the first quarter of 2010, Raptor plans to meet with the Food and Drug Administration ("FDA") and European Medicines Agency ("EMEA") to discuss plans for a repeat-dose, pivotal, Phase 3 clinical trial in cystinosis patients. Upon receiving FDA and EMEA agreements on protocol, Raptor intends to initiate its Phase 3 clinical trial at multiple sites in the US and Europe.
Cystinosis is an inborn metabolic error characterized by the abnormal transport of cystine, an amino acid, out of the lysosomes. Failure to treat cystinosis can cause serious health consequences, including renal failure and resultant kidney transplant, growth failure, rickets, photophobia and blindness. Symptom onset typically occurs within the first year of life, when cystine crystals accumulate in various tissues and organs, including the kidneys, brain, liver, thyroid, pancreas, muscles and eyes.