Aggressive investor
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
be careful....MMs trying to grab all your shares cheap....don't trap yourself in panic selling
cool and the gang playing music behind MM CSTI
power hour will be interesting today maybe explosive....
When PCFG hits $.25, I will donate some money to CSTI
Now i am pulling my hair....why didn't I add more in the morning today!!!
call 911....CSTI burning....help them to put out fire!!!
PCFG #5 at the active board forum....make it number 1 guys
PCFG on the verge of GOLD production....this is not joke CSTI
called CSTI BOSS ...he said he will fire all staff who shorted PCFG
real run will start once PCFG cross $.10....stay calm and hold tight....
shorter still have time to cover ....else train moving to next station .10
close .03 today....shorters will be burnt huge soon
PCFG on the run- 8K news out
PCFG on the run- 8K out
PCFG On the run----8K out
wow....nice to see PCFG getting back to business
BELLEVILLE, Ontario and CHADDS FORD, Pa.-- Bioniche Life Sciences Inc. (TSX: BNC OTC:BNHLF) and Endo Pharmaceuticals (Nasdaq: ENDP) jointly announced today that Endo has licensed from Bioniche the exclusive rights to develop and market Urocidin(TM) in the U.S. with an option for global rights. Urocidin is a patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC) developed by Bioniche for the treatment of non-muscle-invasive bladder cancer that is currently undergoing Phase III clinical testing.
Under the agreement signed by both companies, Endo will pay Bioniche an up-front cash payment of $20M USD and the potential for up to $110M USD in additional payments linked to the achievement of future clinical, regulatory, and commercial milestones. In addition, Bioniche will manufacture the product and receive a transfer price for supply.
"We are excited about the opportunity to expand our portfolio in bladder cancer treatment and enhance our late stage development pipeline," said David Holveck, president and chief executive officer of Endo Pharmaceuticals. "In August Endo plans to launch Valstar(TM), for the treatment of bladder cancer. If successful in clinical development, Urocidin has the potential to extend and enhance our recent therapeutic expansion and strengthen the Valstar franchise."
Graeme McRae, Chairman, President & CEO of Bioniche, added, "Endo Pharmaceuticals represents the optimal development and commercialization partner for Bioniche, given its understanding of the bladder cancer market and breadth of pharmaceutical industry experience. We look forward to advancing the Urocidin development and commercialization program in collaboration with the Endo team. Equally, we are very excited about the potential returns to Bioniche and its shareholders following commercialization of Urocidin."
Bladder Cancer and the Ongoing Phase III Clinical Program for Urocidin(TM)
In North America, bladder cancer is the fourth most common cancer in men and in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year. In addition, the cancers of many previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer at diagnosis and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin.
Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
The first of two Phase III U.S. Food and Drug Administration (FDA)-approved and Fast Track designated registration trials with Urocidin is nearing complete enrolment. In this trial, patients with non-muscle-invasive bladder cancer whose cancer is specifically refractory (unresponsive) to current therapy are receiving Urocidin in an open label trial. Thirty-one urology centres in North America are participating in this trial and recruitment of 105 evaluable patients was completed in March, 2009.
Data from the full cohort of evaluable patients from this trial, coupled with additional safety information to be collected from a second registration trial, will be used to support regulatory submissions under the FDA's Accelerated Approval program.
Bioniche plans to conduct a second registration trial that will directly compare the efficacy and safety of Urocidin with current therapy in the first-line treatment of non-muscle-invasive bladder cancer. In September, 2007, Bioniche announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of MCC when the trial endpoints are achieved. This trial received Fast Track designation by the FDA last year. With Endo's support, Bioniche will commence this multi-centre trial, setting up clinical trial centres immediately.
About Urocidin(TM)
Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan that is recoupable from sales.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and Medium-Sized Employers in Canada for 2009. For more information, please visit www.Bioniche.com.
About Endo Pharmaceuticals Inc.
Endo Pharmaceuticals is a specialty pharmaceutical company engaged in the research, development, sale and marketing of branded and generic prescription pharmaceuticals used to treat and manage pain, overactive bladder, prostate cancer and the early onset of puberty in children, or central precocious puberty (CPP). Its products include LIDODERM(R), a topical patch to relieve the pain of postherpetic neuralgia; PERCOCET(R) and PERCODAN(R) tablets for the relief of moderate-to-moderately severe pain; FROVA(R) tablets for the acute treatment of migraine attacks with or without aura in adults; OPANA(R) tablets for the relief of moderate-to-severe acute pain where the use of an opioid is appropriate; OPANA(R) ER tablets for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time; and VOLTAREN(R) Gel, a nonsteroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment such as those of the hands and the knees. Voltaren(R) Gel is owned and licensed by Novartis AG; SANCTURA(R) and its XR version for treatment of overactive bladder, VANTAS(R) for the palliative treatment of advanced prostate cancer, and SUPPRELIN(R) LA for the treatment of early onset puberty in children. The company markets its branded pharmaceutical products to physicians in pain management, neurology, surgery, oncology, endocrinology and primary care. More information, including this and past press releases of Endo Pharmaceuticals, is available at www.endo.com.
Read the full report: http://biomedreports.com/200907102044/bioniche-life-sciences-inc-and-endo-pharmaceuticals-sign-licensing-agreement-for-urocidintm.html#ixzz12kHZ4UG8
do any of you know current share structure of HESG
this stock is also listed in OTC
BIONICHE LIFE SCIENC
(Public, PINK:BNHLF)
is the game over guys? can we expect some miracle or drama!!!
appears Edwin will dilute all 3.5 Billion shares!!! then run away
Clarification of Bioniche Experiences Increased Trading Activity
BELLEVILLE, ON, Sept. 27 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, has noted substantial share trading volume and share price increase over recent days. Management believes that this market activity is driven by expectation of a disclosure concerning its U.S. Food and Drug Administration (FDA) Phase III Fast Track clinical trial with Urocidin(TM) a product for non-muscle-invasive bladder cancer that is refractory to current first-line therapy. Such disclosure is expected to become available within the next several weeks.
This clinical trial involves the use of an intravesical formulation of a patented mycobacterial cell wall composition: Mycobacterial Cell Wall-DNA Complex (MCC), known as Urocidin(TM) (or "EN3348") for treatment-refractory non-muscle-invasive bladder cancer. The trial completed recruitment of patients in March, 2009, with the last patient reaching his/her one-year assessment this spring. Data compilation has been ongoing since that time, with the Company's development partner, Endo Pharmaceuticals Inc., conducting detailed analyses of the data. Such analyses are still ongoing.
The Company's development partner is the party responsible for oversight of the Urocidin(TM) clinical development program. Status updates on the program and future plans to further develop Urocidin(TM) are being defined and will be disclosed by Endo.
It was announced on August 19, 2010 that the parties are finalizing a protocol for an additional clinical trial - expected to begin enrolling patients in 2010.
About Bladder Cancer
In North America, bladder cancer is the fourth most common cancer in men and is in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. The cancers of many of the previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin(TM).
Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin(TM) is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July, 2009, and has the potential to receive a total of US$110 million in payments associated with the achievement of certain clinical, regulatory and commercial milestones. Four development milestones have been achieved by the Company since November, 2009, resulting in total payments of US$19 million. Future milestones will be announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.
About Urocidin(TM)
Urocidin is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid from sales.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 211 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company's primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
SOURCE Bioniche Life Sciences Inc.
BNC products and pipelines:
http://www.bioniche.com/products.cfm
Bioniche Life Sciences - Gearing Up For D-Day
http://www.rttnews.com/Content/TopStories.aspx?Id=1421944
BNC.TO HITS ANOTHER HIGH TODAY //// ENJOY THE RIDE TO $10+ .
POSITIVE PHASE 3 RESULTS WILL PUSH THIS STOCK TO $6-8 EASILY .PHASE 3 SUCCESS WILL TRIGGER A 60 MIL$+ MILESTONE PAYMENT TO BNC
POSITIVE PHASE III RESULTS IS COMING IN A FEW DAYS .DONT MISS THE NEXT HGSI OR DNDN .YOU´LL BE SORRY .
Bioniche Life Sciences (BNC.TO)
Market Cap: 130 Mil$
Cash: 22 Mil $
Price: 1,80 $
this has potential like DNDN
American Bull HOLD confirmed
http://www.americanbulls.com/StockPage.asp?CompanyTicker=PCFG&MarketTicker=OTC&TYP=S
"Watch for big problems for they disguise big opportunities" H. Jackson Brown
Anyone there got a shot of L2?
PCFG the next pinto beans and money making stocks!!!!
welcome to the gold mine
positive dewatering (crrently working on) news will take us to the moon!!!this will help PCFG secure financing.
might close GREEN
Just When You Thought it Couldn’t Get Any Better....think about PCFG!!
TOUCAN........ do you have any document stating shareholders won't be wiped out?
PCFG established a new 52-week high yesterday. Clearly investors are enthusiastic about the company's prospects. The rally was accompanied by higher than average volume, which adds to the momentum behind yesterday's move.
The question is, can PCFG continue moving higher? The stock has gained 560% during the past month, has a PEG ratio of 0.
Studies have shown that investors who buy stocks after hitting yearly highs during a bull market achieve higher average returns that the broad market indexes. This is a great example of the trader adage that "the trend is your friend." However, these historical results are based on large averages---and some bullish momentum in the market. It is much more difficult to say whether PCFG, as a single stock, will continue to hit new highs. But for the time being, things look promising.
Morning all PCFGers!!!
nice to see MMs are trying hard weak hand out
run has not started yet....this is accumulation phase...
still have 1 hour to go!!! close $.03