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DPDW Off the trend line, recovered the 50... Go time.
Oh yeah! Kool aid! Rock that 50 day!
8:04AM BioLineRx enters into share purchase agreement with Lincoln Park Capital (BLRX) 2.65 : Co announced that it has signed a purchase agreement for the sale, from time to time, of up to $15 mln of its American Depositary Shares with Lincoln Park Capital Fund, LLC a Chicago-based institutional investor. During the 36-month term of the purchase agreement, BioLineRx controls the timing and amount of any sales to LPC, if and when the Company decides, in accordance with the purchase agreement. LPC has no right to require the Company to sell any ADSs to LPC, but LPC is obligated to make purchases as BioLineRx directs, subject to certain conditions.
Crap, I was too slow. I was eying the 10 oz bars. On the gold minute and hourly chart, it pulled back perfectly to the sept 12 breakout. Also, someone posted a gold:silver chart the other day and noted silver usually goes up to correct the ratio, and silver did have a better day yesterday
I like the recent volume trend... bidders very patient so far today, won't last long.
MACK... I just noticed that they had gone public... Searched BV to see the chatter.
The ipo holders have done quite welll. And if dr.bio was right about the 6 month lock out, it looks like the holders will have the chance to sell well above the ipo price. Pps popped pretty big Friday. Wonder if there will be enough selling in October to close this gap.
http://scharts.co/QMREWc
Gold in the trust:
http://static.cdn-seekingalpha.com/uploads/2012/9/23/saupload_12-09-21_gld.png
New highs in price inevitable.
Fuel for the fire!
Great volume today!
ATM's and placements. Last major sales/placement was with Quintiles. Quintiles has options to purchase (at about $2.25) an amount of 1/4 of their purchase. Previous to the ATM Prana would PIPE about $6M shares per year, most recently March 23, 2011. There are options to buy about 1/3 the number of shares at $2.25 associated with that too. There are also options to purchase at $3 from the 2009 placement (all options have a 4 year window).
With this recent run up starting to backfill, I think this would be a good time for the option holders to buy their $2.25 shares.
ATM and link for Australian filings.... ATM sales are listed as "Appendix 3B and Section 708A Notice"
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/July%2014%202011%20At%20the%20market%20issuance%20program.pdf
Quintiles 2010 and 2011:
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/June%2030%202011Quintiles%20second%20investment%20in%20Prana.pdf
March 2011 placement:
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/Prana%20Raises%206.19%20Million.pdf
September 2009 placement
http://www.pranabio.com/downloads/Media%20Releases/Media%20Release%202009/2009%20Sept%209%20Prana%20Secures%206M%20Additional%20Funding.pdf
May 2008 placement:
http://new.pranabio.com/downloads/Media%20Releases/Prana%20Announces%20$7million%20Placement%20to%20Fund%20Research%20Programs%2021%20May%2008.pdf
Govornment and foundation funding:
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/Oct%2027%20Aust%20Fed%20Gov%20Grant%20to%20study%20role%20of%20PBT2%20in%20preventing%20ecitotoxicity.pdf
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/Oct%2020%202011%20Government%20Grant%20to%20Study%20PBT2%20in%20Ageing%20Brain.pdf
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/March%2031%2011%20Pranas%20PBT2%20Ph%20II%20Trial%20Receives%20ADDF%20Funding.pdf
Oops, here's the link
http://www.asx.com.au/asx/research/companyInfo.do?by=asxCode&asxCode=PBT
PRAN: here is a link to the Australian exchange. Scroll down to "announcements" and read the "Appendix 3B and Section 708A Notices" to see the ATM at work... remember Nasdaq shares are 10x Australian shares, so last sales (up to September 18th raised $410,000).
PBTH... PROLOR Biotech to Present Data on Its Long-Acting Human Growth Hormone at Pediatric Endocrinology Meeting
—Data to Be Presented at 51st Annual Meeting of European Society for Paediatric Endocrinology Supports Ongoing Trial of hGH-CTP Administered Once-Weekly in Growth Hormone Deficient Children—
LEIPZIG, Germany and NES-ZIONA, Israel, Sept. 21, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE MKT: PBTH) today announced that data from the company's Phase II trial of hGH-CTP, its long acting human growth hormone, in growth hormone deficient adults will be presented at ESPE 2012, the 51st Annual Meeting of the European Society for Paediatric Endocrinology.
The previously reported data confirmed that a single weekly injection of hGH-CTP has the potential to reduce the required dosing frequency of human growth hormone from the current standard of one injection per day to a single weekly injection. In this trial, hGH-CTP demonstrated a good safety and tolerability profile. In addition, the study showed that only 50-65% of the cumulative weekly dose of conventional human growth hormone was required for the majority of the patients to remain within the normal range of IGF-1, a key biomarker of growth hormone activity. The safety profile of hGH-CTP in this trial was further enhanced by the finding that it did not cause excessive IGF-1 levels in patients, nor was any IGF-I accumulation observed.
The positive Phase II data in adults were instrumental in PROLOR's decision to proceed with a Phase II hGH-CTP trial in growth hormone deficient children that is currently enrolling patients. The pediatric Phase II trial is a randomized, open-label, dose-finding study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamic properties of hGH-CTP injected weekly in children with growth hormone deficiency. The trial is comparing the 12-month growth velocity of children receiving hGH-CTP injected once weekly with those receiving commercially available hGH injected daily.
"Growth hormone replacement therapy may enable a growth hormone deficient child to reach a normal height, but it currently involves daily dosing that may total more than 3,000 injections before the child reaches the age of 18," said Dr. Abraham Havron, CEO of PROLOR. "hGH-CTP has the potential to dramatically reduce this number, thereby making growth hormone therapy less burdensome and more feasible. We welcome the opportunity to raise awareness of our progress with hGH-CTP at this meeting of pediatric endocrinology opinion leaders."
Poster P1-d3-296, Once-Weekly, CTP-Modified hGH (MOD-4023) Effectively Maintains IGF-1 Levels Within the Normal Range in Growth Hormone Deficient Adults, Supporting Initiation of Clinical Development in Children, will be presented during the September 22, 2012 poster session of ESPE 2012, which is being held September 20-23, 2012 in Leipzig, Germany. For more information, visit http://www.espe2012.org/.
I guess the near term catalysts are the small updates that might come out during the trials. They already reported the result from the first DSMB meeting (http://finance.yahoo.com/news/prana-receives-recommendation-proceed-alzheimers-120436854.html). The most exciting thing in that PR is the length of exposure to drug. PBT1 was scrapped due to toxicities and PBT2 was designed to have much better blood brain barrier penetration, which allows for lower dosing and presumably less potential side effects from the rest of the body.
Some patients in the imagine trial have already had 26week interim brain scans and cognitive tests. In the first short phase IIa trial of PB2 patients showed cognitive gains and biomarker changes in only 12 weeks. (http://www.pranabio.com/downloads/Media%20Releases/Success%20in%20Phase%20IIa%20Clinical%20Trial%20of%20PBT2%2026%20Feb%202008.pdf)
So far, the biggest development has been the underwhelming data from bapi and sola, so the perceived value of a drug that has already shown cognition gains and biomarker changes in human trials must be changing.
As far as funding goes there were two grants from Australia for less than $1M each and one grant from Alzheimers drug discovery program, and most recently they are relying on ATM sales. Their broker has been dripping shares onto the market and the pps has held, and gone up nicely on the negative newsflow.
Last major sales/placement was with Quintiles. Quintiles has options to purchase (at about $2.25) an amount of 1/4 of their purchase. Previous to the ATM Prana would PIPE about $6M shares per year, most recently March 23, 2011. There are options to buy about 1/3 the number of shares at $2.25 associated with that too. There are also options to purchase at $3 from the 2009 placement (all options have a 4 year window).
ATM: http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/July%2014%202011%20At%20the%20market%20issuance%20program.pdf
Quintiles 2010 and 2011:
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/June%2030%202011Quintiles%20second%20investment%20in%20Prana.pdf
March 2011 placement:
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/Prana%20Raises%206.19%20Million.pdf
September 2009 placement
http://www.pranabio.com/downloads/Media%20Releases/Media%20Release%202009/2009%20Sept%209%20Prana%20Secures%206M%20Additional%20Funding.pdf
May 2008 placement:
http://new.pranabio.com/downloads/Media%20Releases/Prana%20Announces%20$7million%20Placement%20to%20Fund%20Research%20Programs%2021%20May%2008.pdf
Govornment and foundation funding:
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/Oct%2027%20Aust%20Fed%20Gov%20Grant%20to%20study%20role%20of%20PBT2%20in%20preventing%20ecitotoxicity.pdf
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/Oct%2020%202011%20Government%20Grant%20to%20Study%20PBT2%20in%20Ageing%20Brain.pdf
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202011/March%2031%2011%20Pranas%20PBT2%20Ph%20II%20Trial%20Receives%20ADDF%20Funding.pdf
$DPDW setting up for a boosh... $1.80 then $2.20... If it hits the lower trendline first it would be sweet.
http://scharts.co/RFASNx
Now that a good bit of wind is out of the sails of bapi and sola PRAN is catching a good breeze. Volume has been great.
NYMX... this study so far is for one group of patients, total enrollment is approximately 150... so now you have a new low.
Nymox NX-1207 Prostate Cancer Trial Receives Positive Interim Safety Review From Independent Data Monitoring Committee
HASBROUCK HEIGHTS, N.J., Sept. 20, 2012 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NYMX) is pleased to report that the Independent Data Monitoring Committee for the Company's Phase 2 study of NX-1207 for low risk localized prostate cancer (NX03-0040) has reported a positive interim safety analysis of clinical data from the first group of patients to receive either a high or low dose of NX-1207 for treatment of their localized prostate cancer. The Independent Data Monitoring Committee is an arm's length independent body mandated to conduct periodic interim safety reviews during the study. The Committee has the authority to recommend changes to the study or to halt the study in the event of unacceptable drug toxicity. The Committee's interim safety analysis found no evidence of such toxicity and accordingly the study is continuing.
The NX03-0040 study tests both low and high doses of NX-1207 for their effect on low grade localized prostate cancer. The NX-1207 dose is administered directly into the area of the prostate where the cancer was detected. The procedure is performed by a urologist in an office setting, does not require anaesthesia, sedation, or catheterization, takes only a few minutes and involves minimal discomfort to the patient. Patients in the study are randomly allocated to either low or high dose NX-1207 or to active surveillance (no treatment). Patients undergoing active surveillance in the trial also have the opportunity to receive NX-1207 after their trial active surveillance participation is completed.
The American Cancer Society estimates that in 2012 more than 240,000 men in the United States will be newly diagnosed with prostate cancer and more than 28,000 men will die from the disease. Most cases are detected via prostate-specific antigen (PSA) screening and usually found to have localized tumors. Surgical removal of the prostate (radical prostatectomy) and radiation therapy with or without androgen deprivation therapy are the most common active treatment options for localized prostate cancer but have significant short- and long-term adverse effects, including impotence, urinary dysfunction, and other complications.
NX-1207 is in late stage Phase 3 development in the U.S. for the treatment of benign prostatic hyperplasia (BPH), a common condition of older men associated with growth in prostate size as men age. Phase 3 trial activities of NX-1207 for BPH have recently begun in Europe sponsored by Recordati S.p.A., the company's European licensing partner. In the BPH studies to date, a single dose of NX-1207 has been found to produce symptomatic improvements about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs.
BPH causes progressive difficulties with urination, such as nocturia, urge to void frequently, acute urinary retention and other problems. The condition can seriously impact the health and quality of life of middle aged and older men. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and a high proportion of men as they age suffer from moderate to severe urinary problems and symptoms associated with BPH.
More information about Nymox is available at www.nymox.com, email: info@nymox.com, or 800-936-9669.
QE3... $85 billion per month... $40 billion per month for an open ended time and about &45 billion per month of extended operation twist.
http://finviz.com/futures_charts.ashx?t=GC&p=m5
Prana nice volume on news...
Prana Receives Recommendation to Proceed With Alzheimer's Clinical Trial From Data Safety Monitoring Board (DSMB)
MELBOURNE, AUSTRALIA--(Marketwire - Sep 12, 2012) - Prana Biotechnology ( NASDAQ : PRAN ) ( ASX : PBT ) today reported that it had received a recommendation from the Data Safety Monitoring Board (DSMB) that the IMAGINE trial for Alzheimer's disease should continue as planned based on the initial review of clinical data. The DSMB is an independent group of experts who review the accumulated safety data in ongoing clinical trials, in order to safeguard the interests and safety of participating and future patients. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.
The IMAGINE trial is a double-blind placebo controlled trial enrolling 40 patients with prodromal or mild Alzheimer's disease at five sites in Melbourne, Australia. Brain Imaging is being used to measure PBT2's effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (FDG PET). Cognition effects are being measured by the Neuropsychological Test Battery (NTB).
In the current IMAGINE trial:
100% of sites approved and open for recruitment;
45% of patients in dosing;
Recruitment On Track to report 2H13;
3 patients have reached 28 weeks of dosing -- over double the previous longest exposure to PBT2;
No serious adverse events reported
In an earlier 12 week trial PBT2 both significantly changed amyloid levels in spinal fluid and improved the cognition of patients with Alzheimer's disease. The IMAGINE trial, with 12 months of treatment, aims to establish PBT2 as a safe and effective treatment for Alzheimer's disease. PBT2 has a unique therapeutic action that can benefit people suffering neurodegenerative disease because of its specialized ability to prevent the toxic relationship between disease proteins and the metals, zinc and copper, in the brain.
Prana is also conducting a 6 month trial in 100 patients with early to mid-stage Huntington disease and the company believes that PBT2 has the potential to bring real benefit to Huntington Disease patients who suffer from a range of motor, behavioural and cognitive symptoms. The trial objective is to demonstrate safety, motor and behavioural benefits and the same cognitive benefits for Huntington's patients that it has already demonstrated in Alzheimer's patients treated with PBT2.
PRAN up on news...big volume... this chart doesn't show it but there's 300K plus in the first 30minutes:
http://finance.yahoo.com/news/prana-receives-recommendation-proceed-alzheimers-120436854.html
Prana Receives Recommendation to Proceed With Alzheimer's Clinical Trial From Data Safety Monitoring Board (DSMB)
MELBOURNE, AUSTRALIA--(Marketwire - Sep 12, 2012) - Prana Biotechnology ( NASDAQ : PRAN ) ( ASX : PBT ) today reported that it had received a recommendation from the Data Safety Monitoring Board (DSMB) that the IMAGINE trial for Alzheimer's disease should continue as planned based on the initial review of clinical data. The DSMB is an independent group of experts who review the accumulated safety data in ongoing clinical trials, in order to safeguard the interests and safety of participating and future patients. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.
The IMAGINE trial is a double-blind placebo controlled trial enrolling 40 patients with prodromal or mild Alzheimer's disease at five sites in Melbourne, Australia. Brain Imaging is being used to measure PBT2's effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (FDG PET). Cognition effects are being measured by the Neuropsychological Test Battery (NTB).
In the current IMAGINE trial:
100% of sites approved and open for recruitment;
45% of patients in dosing;
Recruitment On Track to report 2H13;
3 patients have reached 28 weeks of dosing -- over double the previous longest exposure to PBT2;
No serious adverse events reported
In an earlier 12 week trial PBT2 both significantly changed amyloid levels in spinal fluid and improved the cognition of patients with Alzheimer's disease. The IMAGINE trial, with 12 months of treatment, aims to establish PBT2 as a safe and effective treatment for Alzheimer's disease. PBT2 has a unique therapeutic action that can benefit people suffering neurodegenerative disease because of its specialized ability to prevent the toxic relationship between disease proteins and the metals, zinc and copper, in the brain.
Prana is also conducting a 6 month trial in 100 patients with early to mid-stage Huntington disease and the company believes that PBT2 has the potential to bring real benefit to Huntington Disease patients who suffer from a range of motor, behavioural and cognitive symptoms. The trial objective is to demonstrate safety, motor and behavioural benefits and the same cognitive benefits for Huntington's patients that it has already demonstrated in Alzheimer's patients treated with PBT2.
PRAN: Prana Receives Recommendation to Proceed With Alzheimer's Clinical Trial From Data Safety Monitoring Board (DSMB)
MELBOURNE, AUSTRALIA--(Marketwire - Sep 12, 2012) - Prana Biotechnology ( NASDAQ : PRAN ) ( ASX : PBT ) today reported that it had received a recommendation from the Data Safety Monitoring Board (DSMB) that the IMAGINE trial for Alzheimer's disease should continue as planned based on the initial review of clinical data. The DSMB is an independent group of experts who review the accumulated safety data in ongoing clinical trials, in order to safeguard the interests and safety of participating and future patients. The DSMB considers study-specific data as well as relevant background knowledge about the disease, test agent, or patient population under study.
The IMAGINE trial is a double-blind placebo controlled trial enrolling 40 patients with prodromal or mild Alzheimer's disease at five sites in Melbourne, Australia. Brain Imaging is being used to measure PBT2's effect on amyloid deposits in the brain (using PiB-PET scanning) and effects on increasing brain activity (FDG PET). Cognition effects are being measured by the Neuropsychological Test Battery (NTB).
In the current IMAGINE trial:
100% of sites approved and open for recruitment;
45% of patients in dosing;
Recruitment On Track to report 2H13;
3 patients have reached 28 weeks of dosing -- over double the previous longest exposure to PBT2;
No serious adverse events reported
In an earlier 12 week trial PBT2 both significantly changed amyloid levels in spinal fluid and improved the cognition of patients with Alzheimer's disease. The IMAGINE trial, with 12 months of treatment, aims to establish PBT2 as a safe and effective treatment for Alzheimer's disease. PBT2 has a unique therapeutic action that can benefit people suffering neurodegenerative disease because of its specialized ability to prevent the toxic relationship between disease proteins and the metals, zinc and copper, in the brain.
Prana is also conducting a 6 month trial in 100 patients with early to mid-stage Huntington disease and the company believes that PBT2 has the potential to bring real benefit to Huntington Disease patients who suffer from a range of motor, behavioural and cognitive symptoms. The trial objective is to demonstrate safety, motor and behavioural benefits and the same cognitive benefits for Huntington's patients that it has already demonstrated in Alzheimer's patients treated with PBT2.
Nice high volume follow up so far.
PRAN feeling a tailwind from the Pfizer's Bapi failure in August. Prana scientists were invited to speak at a Pfizer sponsored "celebration of science" symposium.
Chart not overbought yet.
http://www.forbes.com/sites/johnlamattina/2012/08/07/for-drugmakers-alzheimers-disease-is-even-tougher-than-cancer/
http://finance.yahoo.com/news/prana-shows-significant-promise-fight-145949092.html
Thanks
I hope so.
Watch for " board marks" number spikes. (currently only 16)
Nice that pran was presenting right under pfizer's nose!
QE3 in sept or oct according to Mohamed El-Erian on Bloomberg.
$COMPQ weekly:
http://scharts.co/NYFdUZ
Rumor about China:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=79305488
Market is surprisingly quiet now that september is here... Maybe the real action starts next week... Fomc on sept 12.
BLRX... Interesting MOA for this drug
BioLineRx In-Licenses a Novel, Phase II Ready Drug for the Treatment of Leukemia and Other Hematological Cancers
- Phase II clinical trials are expected to commence in H1 2013 -
Press Release: BioLineRx Ltd. – 1 hour 52 minutes ago
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Companies:
BioLineRx, Ltd.BIOLINE RX
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BLRX 2.26
JERUSALEM--(BUSINESS WIRE)--
BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a biopharmaceutical drug development company, announced today that it has signed an exclusive, worldwide license agreement with Biokine Therapeutics Ltd., a Clal Biotechnology Industries (CBI.TA) portfolio company, for the development and commercialization of BL-8040 (formerly BKT-140), a Phase II ready drug candidate for the treatment of acute myeloid leukemia (AML), as well as other types of hematological cancer.
BL-8040 is a short peptide that functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis (growth of new blood vessels in the tumor), metastasis (spread of the disease to other organs or organ parts) and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a Phase I/II, open-label, dose escalation, safety and efficacy clinical trial in 16 multiple myeloma patients, BL-8040 demonstrated an excellent safety profile and was well tolerated at all doses tested. On the basis of data obtained from this study, the FDA has approved an IND application.
BL-8040 has been shown to induce the mobilization of healthy hematopoietic stem cells from the bone marrow into the peripheral blood. BL-8040 also mobilizes cancer cells from the bone marrow and other sites and may therefore expose these cells to chemo- and bio-based anti-cancer therapy and induce apoptosis (cell death). Pre-clinical studies show that BL-8040 is efficient, both alone and in combination with the anti-cancer drug Rituximab, in reducing bone marrow metastasis of lymphoma cells and stimulating lymphoma cell death.
Dr. Kinneret Savitsky, CEO of BioLineRx, commented, "BioLineRx has made a strategic decision to enter the field of oncology, where there is clearly an urgent need for next generation anti-cancer therapies utilizing novel biological pathways. We are therefore extremely pleased to in-license this promising Phase II ready drug, which we will initially develop for the treatment of acute myeloid leukemia, a true unmet medical need with very low survival rates. AML is a recognized orphan indication both in the U.S. and the EU; therefore, we plan to seek orphan designation status from the regulatory authorities in order to accelerate its development plan. In addition, based on BL-8040’s promising pre-clinical data, as well its mechanism of action, we believe it can be utilized for several other related oncology indications and we intend to explore these possibilities as well. We look forward to the upcoming Phase II clinical study for evaluating BL-8040’s efficacy on AML patients, which is expected to commence in the first half of 2013."
"We are very happy that BioLineRx will further develop this promising anti-cancer agent, and are confident that BioLineRx’s experience and expertise will advance BL-8040 through the clinical development stages in the most efficient manner,” said Professor Amnon Peled, from the Gene Therapy Institute, Hadassah Medical Center - Jerusalem, founder and CEO of Biokine Therapeutics.
“CXCR4 is one of the most important cancer targets discovered in recent years. It is essential for multiple aspects of cancer progression in over 70% of all cancers, including leukemia, breast, lung, colon, and prostate cancer. BL-8040, as a CXCR4 antagonist, therefore has the potential to target and kill various cancer cells, and studies in animal models of the disease have shown that this agent may stimulate hematological cancer cell death. In addition, for many blood cancers, the bone marrow provides protection for malignant cells from chemotherapeutic agents. Therefore, by inducing mobilization of these cells into the peripheral blood, CXCR4 antagonists literally ‘flush out’ the malignant cells from their hiding places.
“We have demonstrated in pre-clinical studies that BL-8040 is very effective in mobilizing cells out of the bone marrow, thus sensitizing chemo-resistant cells and improving treatment with other anti-cancer drugs," concluded Professor Peled.
Terms of the License Agreement
There are no upfront payments due pursuant to the agreement. BioLineRx is obligated to pay a monthly development fee ranging from $50K to $100K for certain development services that Biokine has committed to provide under the agreement. If the agreed-upon clinical development plan is completed within certain defined timelines, BioLineRx is obligated to pay Biokine a milestone payment of $250K. The agreement does not contain any other milestone payments. Upon any sub-licensing transaction to a third party, BioLineRx is required to pay Biokine a royalty payment on a sliding scale, beginning at 60% of the amounts received as consideration in connection with the sublicensing, and decreasing to 40% of such consideration, based on the aggregate amount of BioLineRx’s investment in the project. Closing of the transaction is subject to formal approval of the Office of the Chief Scientist of Israel’s Ministry of Industry, Trade and Labor.
About Acute Myeloid Leukemia (AML)
AML is a very aggressive form of leukemia, characterized by uncontrolled proliferation of immature white blood cells called myeloid cells in the bone marrow and peripheral circulation. AML is the most common form of adult acute leukemia, accounting for 80% of all diagnosed cases, with approximately 13,000 new cases diagnosed in the U.S., as well as 30,000 new cases diagnosed in the seven leading markets, in 2011. The incidence of AML is expected to further increase as the population of developed countries continues to age.
AML is currently treated with a combination of chemotherapeutic agents and stem cell transplantation. However, the past 20 years have seen little improvement in overall patient survival rates, which are less than 25% within five years from diagnosis. Accordingly, AML is considered a true unmet medical need and there is a significant urgency for developing more effective and tolerable treatments for AML patients, particularly those with relapsed or refractory disease. The AML therapeutics market was estimated at $200 million in 2010, and it is projected to significantly grow with the development of new targeted therapies, reaching over $600 million by 2017. The total leukemia therapeutics market was valued at $6.3 billion in 2010, and is expected to reach $11.3 billion by 2020.
About BioLineRx
BioLineRx is a publicly-traded biopharmaceutical development company. BioLineRx is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx’s current portfolio consists of six clinical stage candidates: BL-1020 for schizophrenia is currently undergoing a Phase II/III study; BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc., is currently undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-1021 for neuropathic pain is in Phase I development, BL-7040 for treating inflammatory bowel disease (IBD) has commenced a Phase II trial, and BL-8040 for treating acute myeloid leukemia (AML) has completed Phase I. In addition, BioLineRx has nine products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, infectious diseases, cardiovascular and autoimmune diseases.
BioLineRx’s business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government’s Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visit www.biolinerx.com.
http://finance.yahoo.com/news/biolinerx-licenses-novel-phase-ii-110000227.html
Prana's Parkinson's Drug Meets Michael J. Fox Foundation Development Milestone
PBT434 Advances Through IND Enabling Studies
Press Release: Prana Biotechnology – 17 minutes ago
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Companies:
Prana Biotechnology Ltd.Prana Biotechnology Ltd.
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PRAN 1.7301 +0.0401
MELBOURNE, AUSTRALIA--(Marketwire -08/29/12)- Prana Biotechnology Limited (PRAN) (PBT.AX) announced today that its lead compound in development for Parkinson's disease (PD), PBT434, had progressed successfully though a series of preclinical development studies used to assess the suitability of a candidate compound for human clinical studies. The studies were funded by The Michael J. Fox Foundation (MJFF) 2011 Pipeline Program to support its 'Therapeutic Development Initiative.' The MJFF Program grant is milestone based. PBT434 achieved all of its milestones in preclinical toxicology studies, genotoxicity and safety pharmacology -- allowing the compound to be positioned for larger scale animal toxicology studies prior to commencing clinical trials.
PBT434 is a novel, orally available compound that easily crosses into the brain and is able to exert potent neuroprotective properties. Most particularly, it preserves the brain tissue in PD that degenerates over time, the substantia nigra. By preserving this tissue, Prana's scientists have demonstrated significant restoration of motor coordination and strength in animal models. PBT434 has been shown that it is able to impede the iron-induced oxidative damage and neurotoxic cascade that kills the substantia nigra. As such, PBT434's mechanism of action offers a novel disease modifying therapeutic strategy in contrast to the currently marketed symptomatic agents that, at best, serve to reduce the side effects of the disease rather than alter its course.
"Based on these efficacy studies and now the completion of this suite of preclinical development assessments, Prana will look to move PBT434 into longer term toxicology studies in parallel to our scale up manufacturing plans for PBT434. All being well, we could file an IND by the end of next year and commence clinical trials in 2014," said Mr. Geoffrey Kempler, Prana's Executive Chairman. "PBT434 also marks another product pipeline milestone for Prana to complement our two ongoing trials with PBT2 in Alzheimer's disease and Huntington disease," commented Mr. Kempler.
Parkinson's disease is a devastating illness which can result in not only the loss of muscle control, speech, balance and digestive functions; it may also impair a patient's psychiatric and cognitive function. With 4 million people affected worldwide, Parkinson's disease is the second most common neurological indication behind Alzheimer's disease. The current market size for drugs to treat Parkinson's disease is approximately $4 billion per year; however most currently available drugs primarily treat the symptoms and do not actually prevent the ongoing destruction of the substantia nigra in the brain and progression of the disease.
* The program grant title is 'PBT434, a novel neuroprotective drug for Parkinson's Disease; completion of pre-clinical studies to enable human clinical trials.'
Prana's Parkinson's Drug Meets Michael J. Fox Foundation Development Milestone
PBT434 Advances Through IND Enabling Studies
Press Release: Prana Biotechnology – 17 minutes ago
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PRAN 1.7301 +0.0401
MELBOURNE, AUSTRALIA--(Marketwire -08/29/12)- Prana Biotechnology Limited (PRAN) (PBT.AX) announced today that its lead compound in development for Parkinson's disease (PD), PBT434, had progressed successfully though a series of preclinical development studies used to assess the suitability of a candidate compound for human clinical studies. The studies were funded by The Michael J. Fox Foundation (MJFF) 2011 Pipeline Program to support its 'Therapeutic Development Initiative.' The MJFF Program grant is milestone based. PBT434 achieved all of its milestones in preclinical toxicology studies, genotoxicity and safety pharmacology -- allowing the compound to be positioned for larger scale animal toxicology studies prior to commencing clinical trials.
PBT434 is a novel, orally available compound that easily crosses into the brain and is able to exert potent neuroprotective properties. Most particularly, it preserves the brain tissue in PD that degenerates over time, the substantia nigra. By preserving this tissue, Prana's scientists have demonstrated significant restoration of motor coordination and strength in animal models. PBT434 has been shown that it is able to impede the iron-induced oxidative damage and neurotoxic cascade that kills the substantia nigra. As such, PBT434's mechanism of action offers a novel disease modifying therapeutic strategy in contrast to the currently marketed symptomatic agents that, at best, serve to reduce the side effects of the disease rather than alter its course.
"Based on these efficacy studies and now the completion of this suite of preclinical development assessments, Prana will look to move PBT434 into longer term toxicology studies in parallel to our scale up manufacturing plans for PBT434. All being well, we could file an IND by the end of next year and commence clinical trials in 2014," said Mr. Geoffrey Kempler, Prana's Executive Chairman. "PBT434 also marks another product pipeline milestone for Prana to complement our two ongoing trials with PBT2 in Alzheimer's disease and Huntington disease," commented Mr. Kempler.
Parkinson's disease is a devastating illness which can result in not only the loss of muscle control, speech, balance and digestive functions; it may also impair a patient's psychiatric and cognitive function. With 4 million people affected worldwide, Parkinson's disease is the second most common neurological indication behind Alzheimer's disease. The current market size for drugs to treat Parkinson's disease is approximately $4 billion per year; however most currently available drugs primarily treat the symptoms and do not actually prevent the ongoing destruction of the substantia nigra in the brain and progression of the disease.
* The program grant title is 'PBT434, a novel neuroprotective drug for Parkinson's Disease; completion of pre-clinical studies to enable human clinical trials.'
I'd love to see Dow:gold at 1 as long as Dow holds 8k!
http://us.rd.yahoo.com/finance/external/pssa/SIG=13a6slvt6/*http://seekingalpha.com/article/825811-dow-gold-ratio-chart-portends-continuation-of-economic-depression?source=yahoo
Prana Provides Clinical Trials Update
Alzheimer’s and Huntington disease trials on track
Melbourne – 22 August, 2012; Prana Biotechnology (NASDAQ:PRAN; ASX:PBT)
today reported on its progress in its Phase II clinical trials with its lead development
asset PBT2. PBT2 has a unique therapeutic action that can benefit people suffering
neurodegenerative disease because of its specialized ability to prevent the toxic
relationship between disease proteins and biological metals in the brain.
Prana’s world leading work in neurodegenerative diseases is capturing significant
international recognition, particularly at a time when other potential treatments are failing.
"There is mounting evidence that compounds that can restore metal homeostasis in the
neuron can stop and even reverse cognitive decline associated with neurodegenerative
diseases. We think Prana's PBT2 could be such a compound," said New York based
MLV & Co. Equity Research, Senior Biotech Analyst George Zavoico, Ph.D. The full
report is available at www.pranabio.com.
Alzheimer’s disease Trial Update – the “IMAGINE” trial
In an earlier 12 week trial PBT2 both significantly changed amyloid levels in spinal fluid
and improved the cognition of patients with Alzheimer’s disease.
1,2
The IMAGINE trial,
with 12 months of treatment, aims to establish PBT2 as a safe and effective treatment
for Alzheimer’s disease. The following provides an update on the trial:
100% of sites approved and open for recruitment;
40% of patients in dosing;
Recruitment On Track to report 2H13;
3 patients have reached 24 weeks of dosing – doubling the previous longest
exposure to PBT2;
No serious adverse events reported; and
First Data Safety Monitoring Board meeting in September 2012, reporting on
safety and tolerability.
The randomized, double-blind, placebo controlled trial is enrolling 40 patients with
prodromal or mild Alzheimer’s disease in five sites in Melbourne, Australia. Brain
Imaging is being used to measure PBT2’s effect on amyloid deposits in the brain (using
PiB-PET scanning) and effects on increasing brain activity (FDG PET). Cognition effects
are being measured by the Neuropsychological Test Battery (NTB).
“The results of the IMAGINE trial will be closely watched by the Alzheimer’s community,
given the recent failure of several late-stage therapeutic candidates. We believe that
PBT2’s mechanism of action explains the clinical benefits that the drug has already
shown, and we anticipate positive results from this trial,” said Chief Executive Officer, Mr
Geoffrey Kempler. The trial has received funding from the Alzheimer’s Drug Discovery Foundation (ADDF).
Howard Fillit, MD, the ADDF’s Executive Director commented, “PBT2 stands out as one
of the few orally available agents with clinical trial evidence of cognitive benefit for
Alzheimer’s patients. Success in this trial will demonstrate target engagement by PBT2
in the brain of people with Alzheimer’s disease, and accelerate the clinical development
of PBT2 to patients.”
The protocol for the IMAGINE trial is available by clicking here.
Huntington Disease Trial Update – the “Reach2HD” trial
The Reach2HD trial is a 6 month trial in 100 patients with early to mid-stage Huntington
disease. An IND was opened to conduct the trial across sites in the USA and Australia.
The following provides an update on the trial:
70% of sites approved and open for recruitment;
14% patients in dosing;
Recruitment On Track to report 2H13;
No serious adverse events reported; and
First Data Safety Monitoring Board meeting in October 2012, reporting on safety
and tolerability.
Professor Ira Shoulson, Professor of Neurology, Pharmacology and Human Science at
Georgetown University (Washington DC) and the Chair of the Executive Committee of
the Huntington Study Group said: “PBT2 attracted our attention as an experimental drug
with the potential to bring real benefit to Huntington disease patients who suffer from a
range of motor, behavioural and cognitive symptoms. The favourable signals from the
PBT2 trial in Alzheimer’s disease are particularly promising.”
Only one drug is marketed for Huntington disease and that is only for the relief of the
severe motor or chorea symptoms. There are no approved treatments for the significant
cognitive and behavioural components of the disease, which typically manifest before
motor problems.
“The trial objective is to demonstrate safety, motor and behavioural benefits and the
same cognitive benefits for Huntington’s patients that it has already demonstrated in
Alzheimer’s patients treated with PBT2,” said Mr Kempler.
The protocol and site updates for the Reach2HD trial can be accessed by clicking here.
References
1.
Lannfelt et al. Lancet Neurology (2008) vol. 7, pp. 779-86;
2.
Lannfelt et al. Erratum: Lancet Neurology (2009) vol. 8, pp. 981.
About Prana Biotechnology Limited
Prana Biotechnology was established to commercialize research into age-related
neurodegenerative disorders. The Company was incorporated in 1997 and listed on the
Australian Securities Exchange in March 2000 and listed on NASDAQ in September 2002.
Researchers at prominent international institutions including The University of Melbourne, The
Mental Health Research Institute (Melbourne) and Massachusetts General Hospital, a teaching
hospital of Harvard Medical School, contributed to the discovery of Prana’s technology.
For further information please visit the Company’s web site at www.pranabio.com.About Huntington disease
Huntington disease is a complex and severely debilitating genetic, neurodegenerative disease,
for which there is no cure. The disease often affects young adults and, whilst associated with
severe physical movement symptoms, progressively impacts the mind and emotions as well. The
disease causes incapacitation and death about 15-25 years after onset. The disease affects
30,000 people in the US and about 70,000 worldwide. There are no drugs in development that
have established clinical evidence for treating cognitive decline.
About the Alzheimer’s Drug Discovery Foundation
The Alzheimer’s Drug Discovery Foundation (ADDF) is the only non-profit organization whose
sole mission is to accelerate the discovery and development of drugs to prevent, treat and cure
Alzheimer’s disease, related dementias and cognitive aging. Since 1998, the ADDF has granted
more than $50 million to fund over 325 Alzheimer’s drug discovery programs in academic centers
and biotechnology companies in 18 countries. For more information about the Foundation, please
visit www.AlzDiscovery.org.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of section 27A of the
Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company
has tried to identify such forward-looking statements by use of such words as "expects,"
"intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and
other similar expressions, but these words are not the exclusive means of identifying such
statements. Such statements include, but are not limited to any statements relating to the
Company's drug development program, including, but not limited to the initiation, progress and
outcomes of clinical trials of the Company's drug development program, including, but not limited
to, PBT2, and any other statements that are not historical facts. Such statements involve risks
and uncertainties, including, but not limited to, those risks and uncertainties relating to the
difficulties or delays in financing, development, testing, regulatory approval, production and
marketing of the Company’s drug components, including, but not limited to, PBT2, the ability of
the Company to procure additional future sources of financing, unexpected adverse side effects
or inadequate therapeutic efficacy of the Company's drug compounds, including, but not limited
to, PBT2, that could slow or prevent products coming to market, the uncertainty of patent
protection for the Company's intellectual property or trade secrets, including, but not limited to,
the intellectual property relating to PBT2, and other risks detailed from time to time in the filings
the Company makes with Securities and Exchange Commission including its annual reports on
Form 20-F and its reports on Form 6-K. Such statements are based on management’s current
expectations, but actual results may differ materially due to various factions including those risks
and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely
on those forward-looking statements as a prediction of actual future results.
Contacts:
Australia
Prana Biotechnology
+61 3 9349 4906
US
Leslie Wolf-Creutzfeldt
T: 646-284-9472
E: leslie.wolf-creutzfeldt@grayling.com
Media:
Ivette Almeida
T: 646-284-9455
E: Ivette.almeida@grayling.com
http://www.pranabio.com/downloads/Media%20Releases/Media%20Releases%202012/August%2022%20Prana%20Provides%20Clinical%20Trials%20Update.pdf
http://www.pranabio.com/downloads/analyst_reviews/MLV%2012-0810_PRAN_Update-AD-HD-Ph2.pdf
Pran up huge in Australia last night...
http://www.asx.com.au/asx/research/companyInfo.do?by=asxCode&asxCode=PBT
http://scharts.co/MmnpTe
$PRAN up huge on big volume last night in Australia.