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SEC: Institution just bought 9% of CLRB,
and it becomes 2nd largest investor at low price per share.
IT MAKES ONE WONDER WHAT THEY KNOW,
https://fintel.io/so/us/clrb
3 BAGGER in 90 days?
Cellectar Expands Third Cohort of its Phase 2
CLOVER-1 Study of CLR 131
Response rate exceeded pre-specified value; top-line results of Phase 2 study expected in
2019
FLORHAM PARK, N.J., May 21, 2019 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB),
clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of drugs for
the treatment of cancer, today announced that initial results from the third cohort of its ongoing Phase 2 CLOVER-1
study of CLR 131 have exceeded its pre-specified performance criteria.
As a result, the Company will expand the
number of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma
(LPL) and marginal zone lymphoma (MZL) patients it will enroll in the cohort. The company continues to expect to
report top-line data from the Phase 2 CLOVER-1 study in 2019.
“Initial results from our Phase 2 CLOVER-1 study have been very encouraging and we are excited to be able to
expand patient enrollment,” stated James Caruso, president and chief executive officer of Cellectar Biosciences.
“With the proceeds from the recently announced financing, we now have a cash runway through the conclusion of
2020, allowing us to deliver key anticipated milestones for CLR 131 in three ongoing clinical trials, including the
conclusion of and top-line data from our ongoing Phase 2 CLOVER-1 trial in relapse/refractory select B-Cell
malignancies, our ongoing Phase 1 dose-escalating trial in relapsed/refractory multiple myeloma, and our recently
initiated Phase 1 dose-escalating trial in children and adolescents with select solid tumors, lymphoma, and malignant
brain tumors.”
The company previously announced positive top-line data from two cohorts of the ongoing Phase 2 CLOVER-1 trial.
In the relapsed/refractory diffuse large b-cell lymphoma (DLBCL) cohort, CLR 131 demonstrated a 33% overall
response rate as a fourth line systemic treatment; and in the relapsed/refractory multiple myeloma (MM) cohort, CLR
131 demonstrated a 30% overall response rate as the seventh line systemic treatment on average. Patients in both
of these cohorts received a single 30-minute infusion of 25mCi/m2 of CLR 131. The company continues to enroll
patients in both cohorts and patients are now receiving 37.575mCi/m2 of CLR 131 administered in two 30-minute
infusions of 18.75mCi/m2.
The company expects to announce top-line data from the Phase 2 CLOVER-1 trial in
2019.
About the Phase 2 CLOVER-1 Trial
CLOVER-1 is a Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the
United States in patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers being
studied in the trial include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic lymphoma
(CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and
diffuse large B-cell lymphoma (DLBCL).
The study's primary endpoint is clinical benefit response (CBR), with additional endpoints of overall response rate
(ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a
fractionated dose of 37.575mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131
administered on day 1 and day 8, with the option for a second dose cycle approximately 75-180 days later.
In addition to receiving the two fractionated doses of CLR 131, MM patients will receive 40 mg oral dexamethasone
weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple Myeloma
Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria. Cellectar
was awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund
the trial. More information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov,
reference NCT02952508.
About CLR 131
CLR 131 is a small-molecule, cancer-targeting radiotherapeutic PDC designed to deliver cytotoxic radiation directly
and selectively to cancer cells and cancer stem cells. CLR 131 is the company’s lead therapeutic PDC product
candidate and is currently being evaluated in both Phase 2 and Phase 1 clinical studies. In December 2014, the
FDA granted orphan drug designation for CLR 131 for the treatment of multiple myeloma. In 2018, the FDA granted
orphan drug and rare pediatric disease designations for CLR 131 for the treatment of neuroblastoma,
rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. In addition to the ongoing Phase 1 dose-escalation study
and the Phase 2 CLOVER-1 trial, the company recently initiated a Phase 1 open-label, dose-escalating study in
pediatric solid tumors and lymphoma to evaluate the safety and tolerability of a single intravenous administration of
CLR 131 in up to 30 children and adolescents with cancers including neuroblastoma, sarcomas, lymphomas
(including Hodgkin’s lymphoma) and malignant brain tumors
Yes, typical, sell the CLRB news,
LEARNED BEHAVIOR UNTIL THE BEAR TRAP IS SPRUNG,
LATER THIS YEAR...October???
Quick 50% retracement of gains,
while folks in NYC were out to lunch.
This will work for 4 or 5 more months, then spikes will become bear traps- not bull traps.
Happy ?? to learn long ago not to buy the spikes. Just buy the winners cheap & hold them close.
It took 4 months, BUT:
See my January post #7829 linked above:
Where will we be in 4 more months? 6 months?
$6 pps?
Bots are learning today
A down market day as it gets into the afternoon!
So true, whytestocks:
“...Thinly traded nano cap Cellectar Biosciences (CLRB +30.7%) is up on a robust 32x surge in volume in reaction to preliminary data from Cohort 6 in its Phase 1 study of CLR 131 in patients with relapsed/refractory multiple myeloma.
Results showed a 50% partial response rate, a 50% minimal response rate and a 100% disease control rate (responders + stable cancer).
The company has initiated a seventh cohort at a higher dose. Interim data should be available in Q4.
CLR 131 is a phospholipid ether-drug conjugate (PDC) that selectively delivers radiation to malignant cancer cells...” SA
No wonder the FDA backs CLRB
with Fast Track Status to get CLR131 to market. It is MM patients last best chance to live.
I would pay $75,000 per infusion for it, in order to live 2 or 3 more years. A LOT MORE cures can be found in 2 or 3 years.
Growth EXCEEDS share dilution,
...and EVERYBODY CAN WIN.
CLRB WILL BE A BLESSING to cancer patients and to investors.
Thank God!
A NEW DAY FOR CLRB IS READY TO DAWN,
as sunofwolf’s negative BS slowly sets in the west, to be forgotton,
CLRB PROVES ITS FUTURE IN A NEW DAY OF HOPE IN TODAY’ S PR AND MANY MORE LIKE IT TO COME THIS YEAR.
As a MM patient, I applaud this biotech company and all it is doing to protract human lives !
A cure is a dream; an effective cancer management technology is reality. CLRB!
Fast Track Status for CLR131
from the FDA today for refractory MM?
That sets the table for the next spike over 2.75 not to retrace.
Share dilution by management sets the table for more depressing BS.
PLACE YOUR BETS
Up 130% today, sound familiar?
Similar to IHUB IN SOME WAYS:
https://www.cnbc.com/quotes/?symbol=MGNX&tab=profile
NOT TRUE anymore but
The clinical trials were delayed their progress for a few months last year by industry wide FDA regulation of imported radioactive substances:
https://www.cellectar.com/news-media/press-releases/detail/194/cellectar-announces-fda-grants-exemption-to-import-alert
WHAT WOULD YOU PAY TO LIVE
2 years longer?
Cellectar Biosciences Reports Median Survival of 22 Months in Ongoing Phase 1 Trial Evaluating CLR 131 for Relapsed/Refractory Multiple Myeloma
BY MT Newswires
— 4:06 PM ET 01/07/2019
04:06 PM EST, 01/07/2019 (MT Newswires) -- Cellectar Biosciences ( CLRB
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) announced median overall survival (mOS) in cohorts 1 to 4 of the company's ongoing phase 1 clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM).
The results showed mOS of 22 months among 15 patients, all of whom were heavily pretreated, averaging five prior lines of systemic therapy. Each patient in cohorts 1 to 4 of the dose-escalation study received a single 30-minute infusion of CLR 131.
"The median overall survival of 22 months in this heavily pretreated patient population is very encouraging. These are patients with limited therapeutic options and, unfortunately, face poor prognoses," said James Caruso, president and chief executive officer of Cellectar Biosciences ( CLRB
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).
"The convenience afforded by CLR 131 delivered in only one or two doses as currently administered in our ongoing hematology studies makes it a far less intrusive regimen than other treatments that must be administered at regular dosing intervals. We believe extending mOS with a more patient-friendly dosing regimen provides both a distinctive product profile and the potential to provide beneficial patient outcomes even in later lines of therapy," Caruso added.
Price: 1.8600, Change: +0.1400, Percent Change: +8.14
I bet clinical trials are progressing well,
Now that the radioactive element IS available again...bloody Government delay last year!
Yes, clinical trial progress is reportedly OUTSTANDING.
This company will monetize its efforts sooner than most think here.
REJECT DISINFORMATION AND DO YOUR OWN RESEARCH.
READ! TALK TO CLRB IR ...live long and prosper.
For example:
Cellectar Biosciences Reports Median Survival of 22 Months in Ongoing Phase 1 Trial Evaluating CLR 131 for Relapsed/Refractory Multiple Myeloma
BY MT Newswires
— 4:06 PM ET 01/07/2019
04:06 PM EST, 01/07/2019 (MT Newswires) -- Cellectar Biosciences ( CLRB
Loading...
Loading...
) announced median overall survival (mOS) in cohorts 1 to 4 of the company's ongoing phase 1 clinical trial evaluating CLR 131 for the treatment of relapsed/refractory (R/R) multiple myeloma (MM).
The results showed mOS of 22 months among 15 patients, all of whom were heavily pretreated, averaging five prior lines of systemic therapy. Each patient in cohorts 1 to 4 of the dose-escalation study received a single 30-minute infusion of CLR 131.
"The median overall survival of 22 months in this heavily pretreated patient population is very encouraging. These are patients with limited therapeutic options and, unfortunately, face poor prognoses," said James Caruso, president and chief executive officer of Cellectar Biosciences ( CLRB
Loading...
Loading...
).
"The convenience afforded by CLR 131 delivered in only one or two doses as currently administered in our ongoing hematology studies makes it a far less intrusive regimen than other treatments that must be administered at regular dosing intervals. We believe extending mOS with a more patient-friendly dosing regimen provides both a distinctive product profile and the potential to provide beneficial patient outcomes even in later lines of therapy," Caruso added.
Price: 1.8600, Change: +0.1400, Percent Change: +8.14
I am buying before it’s too late,
Sonofwolf.
TENB is forming a bottom this month,
And is in good cybersecurity company going forward:
https://eresearch.fidelity.com/eresearch/evaluate/news/basicNewsStory.jhtml?symbols=TENB&storyid=201901020856MIDNIGHTUSEQUITY_A1811547&provider=MIDNIGHT&product=USEQUITY&sb=1
Before it is too late,
TO SAY IT: HAPPY NEW YEAR!
Sunofwolf: And it is getting cheaper
By the day!
This stock needs to finish a clinical trial and get FDA approval of at least one platform/drug so it can monetize it.
Profits really help make earnings per share & save patient lives.
The slow but constant accumulation continues:
I just noticed the TENB is now one of the top 3 holdings in HACK, the Cybersecurity ETF.
Understood. That’s cool. Reasonable.
Agree with your previous posts about CLRB NEEDING LOTS OF TIME and money to see what clinical trials will reveal.
Investors and current MM patients and other disease patients are not blessed with unlimited TIME.
BUT there are other future investors and patients who could greatly benefit from this company.
TIMING IS EVERYTHING, AS YOU HAVE POINTED OUT.
3.74% continued bounce up today, but
it could not hold $34.40’s interday highs as opposed to yesterday closing very near the highs.
Continued accumulation or up cycle ending with declining price/volume?
4.35% bounce back today,
With a constructive daily chart for pattern for the day: gradual and persistent buying- closing neat the highs of the day.
No news today, so this stock was over sold, or better yet, seeing accumulation if this keeps up.
Who wants yesterday’s papers?
“Who wants yeste’s girl?”
Or even “who wants last week’s papers?.......
BRIEF-Fractionated Dosing Improves Tolerability And Safety Of Cellectar’S Clr 131 In R/R Multiple Myeloma Patients
REUTERS - 8:42 AM ET 8/20/2018
COMPANY NEWS
Aug 20 (Reuters) - Cellectar Biosciences Inc (CLRB)
:
* FRACTIONATED DOSING IMPROVES TOLERABILITY AND SAFETY OF CELLECTAR’S CLR 131 IN R/R MULTIPLE MYELOMA PATIENTS
* CELLECTAR BIOSCIENCES-DMC DETERMINED FRACTIONATED DOSE USED IN COHORT 5 TO BE SAFE & WELL TOLERATED & RECOMMENDED ADVANCEMENT TO A HIGHER DOSE COHORT
* CELLECTAR BIOSCIENCES INC (CLRB)
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- COMPANY INTENDS TO INITIATE A SIXTH COHORT AND TRANSITION ONGOING PHASE 2 TRIAL TO A FRACTIONATED DOSE Source text for Eikon: Further company coverage: (Reuters.Briefs@thomsonreuters.com)
So CLRB IS ALREADY IN AN “ONGOING” PHASE 2 TRIAL WITH CLR131 FOR MULTIPLE MYELOMA?
There could be some phase 2 news this year then, for this “pokey puppy”?
No news yet that CRB sold its FDA voucher getting about $125M from another company.
“...Priority review vouchers can be used by the sponsor to receive priority review designation for a future NDA or BLA submission, which could reduce the FDA review time from twelve months to eight months. Currently, these vouchers can also be transferred or sold to another entity. Since the beginning of 2017, six priority review vouchers were sold for between $80 million and $150 million each...”
I would be tempted to do so unless, for example, there were a more profitable alternative use of the voucher in getting a CLR131 platform to market 4 months earlier with FDA BLESSINGS.
Either way we want NO MORE REVERSE COMMON STOCK SHARE SPLITS!
Analyst upgrade by Thompson Reuters:
Thomson Reuters/Verus upgrades CELLECTAR BIOSCIENCES INC from HOLD to BUY.
BY Investars Analyst Actions - public
— 5:18 PM ET 08/20/2018
On August 20, 2018 Thomson Reuters/Verus upgraded CELLECTAR BIOSCIENCES INC ( CLRB
from HOLD to BUY
Surprised analysts are taking any notice of little old CLRB already. CT must be interesting to the professionals.
But as noted before, Company needs to get more products into Phase 2 clinical trials at their cash burn rate.
Would “fractionated dosing” double revenues on CLR131 for MM?
It does not seem like a stretch to think so:
https://www.cellectar.com/news-media/press-releases/detail/187/fractionated-dosing-improves-tolerability-and-safety-of
I agree, Phase II Trials are needed now to avoid further free cash burn before monetizing this of Product! (Or another reverse split.)
IPO FALL OUT LINGERS,
as much as 30 days post IPO?
Today’s Comprehensive news release:
https://eresearch.fidelity.com/eresearch/evaluate/news/basicNewsStory.jhtml?symbols=TENB&storyid=201808081200PRIMZONEFULLFEED7339891&provider=PRIMZONE&product=FULLFEED&sb=1
Tenable Research Reveals Nearly Half of Organizations Use Strategic Vulnerability Assessment as Foundation of Cyber Defense
BY GlobeNewswire
— 12:00 PM ET 08/08/2018
LAS VEGAS, Aug. 08, 2018 (GLOBE NEWSWIRE) -- Tenable®, Inc., the Cyber Exposure company, released The Cyber Defender Strategies Report today that uses data science against real-world telemetry data to analyze how 2,100 organizations are assessing their exposure to vulnerabilities, a critical component to improving overall cybersecurity posture.
The report shows that nearly 48 percent of organizations globally have embraced strategic vulnerability assessment -- defined as mature or moderately mature programs that include targeted and tailored scanning and prioritizing computing resources based on business criticality -- as a foundational element of their cyber defense and a critical step toward reducing risk. Of those organizations, however, only five percent display the highest degree of maturity, with comprehensive asset coverage as a cornerstone of their programs. On the other end of the spectrum, 33 percent of organizations take a minimalistic approach to vulnerability assessments, doing the bare minimum as required by compliance mandates and increasing the risk of a business-impacting cyber event.
Image: Tenable Cyber Defender Strategies Report: Highlights
Vulnerability assessment style percentages among enterprises in the data set
Tenable’s last report, “Quantifying the Attacker’s First-Mover Advantage,” revealed that attackers generally have a median seven-day window of opportunity to exploit a known vulnerability, before defenders have even determined they are vulnerable. The resulting seven-day gap is directly related to how enterprises are conducting vulnerability assessments -- the more strategic and mature the approach, the smaller the gap is likely to be and the lesser the risk to the business.o
“In the not too distant future, there will be two types of organizations -- those who rise to the challenge of reducing cyber risk and those who fail to adapt to a constantly evolving and accelerating threat landscape in modern computing environments,” said Tom Parsons, senior director of product management, Tenable. “This research is a call to action for our industry to get serious about giving the advantage back to cyber defenders, starting with the rigorous and disciplined assessment of vulnerabilities as the basis for mature vulnerability management and ultimately, Cyber Exposure.”
Tenable Research analyzed telemetry data for over three months from organizations in more than 60 different countries using data science to identify distinct security maturity styles and strategic insights which can help organizations manage, measure and ultimately reduce cyber risk. The objective was to analyze and ultimately help to improve how defenders are responding.
Key findings include:
•
There are four distinct strategies of vulnerability assessment:
The Minimalist executes bare minimum vulnerability assessments as required by compliance mandates. Thirty-three percent of organizations fall into this category, running limited assessments on only selected assets. That represents a lot of enterprises which are exposed to risk and still have some work to do, with critical decisions to make on which KPIs to improve first.
The Surveyor conducts frequent broad-scope vulnerability assessments, but with little authentication and customization of scan templates. Nineteen percent of organizations follow the Surveying style, placing them at a low to medium maturity.
The Investigator executes vulnerability assessments with a high maturity, but only assesses selective assets. Forty-three percent follow the Investigative style, indicating a solid strategy based on a good scan cadence, targeted scan templates, broad asset authentication and prioritization. Considering the challenges involved in managing vulnerabilities, securing buy-in from management, cooperating with disparate business units such as IT operations, maintaining staff and skills, and the complexities of scale, this is a great achievement and provides a solid foundation upon which to mature further.
The Diligent represents the highest level of maturity, achieving near-continuous visibility into where an asset is secure or exposed and to what extent through high assessment frequency. Only five percent of organizations fall into this category, displaying comprehensive asset coverage, targeted, customized assessments and tailoring scans as required by use case.
• Across all levels of maturity, organizations benefit from avoiding a scattershot approach to vulnerability assessment and instead making strategic decisions and employing more mature tactics such as frequent, authenticated scans to improve the efficacy of vulnerability assessment programs.
For more information on the research, read the Tenable Research blog post here, https://www.tenable.com/blog/how-mature-are-your-cyber-defender-strategies.
Visit Tenable at Black Hat USA 2018 in Las Vegas (booth 404).
After the IPO, LET THERE BE LIGHT!
Post #1...here we go, up 8.29% today.
From Seking Alpha:
Tenable (TENB) is the latest cybersecurity company to go public this year following the highly anticipated offerings from Zscaler (ZS) and Carbon Black (CBLK). I believe all of these companies are great pure plays in the cybersecurity industry and their unique SaaS platform is a competitive advantage over their legacy counterparts. I recent wrote an article on why CBLK is a great investment since their price has settled since their hot IPO.
TENB offers cloud-based vulnerability management services which helps protect an enterprises assets such as network containers and web applications. Their SaaS based approach is favorable compared to legacy players who still provide hardware offerings. TENB continues to grow and take market share, and their software offerings deserve a premium trading multiple.
And yet you still post here?
And you kindly moderate this board?
INTERESTING....
Accumulation ever since 10 am ET today,
...of course it is not likely to last based upon a long (2 year) history for this stock.
In my humble opinion, of course....
Guts of last PR, including ORR:
“After a single 25.0 mCi/m2 IV administration of CLR 131, patients with relapsed/refractory DLBCL were assessed for response. These interim data show a 33% overall response rate (ORR) and a 50% clinical benefit response (CBR). In addition, the observed responses to date show overall tumor reduction ranged from 60% to greater than 90%. As a result of these favorable outcomes, the company has expanded this cohort to include up to 30 additional patients...”
Thanks, Ryman !
In the meantime, folks long will sell the good news spikes in share price to exit losing positions, and then some shorts will step in (especially after the reverse split) the afternoon. Same old, same old!
Gravity sucks....
Nice but naughty?
You have been right so far over the last year.
It will take another year or so to finish clinical trials. At the current “burn rate”, without cash infusion, may not make the finish line. Is that correct?
Agree that without more great results near term, shorts are accumulating against the new dilution; I mean against the reverse split. Gravity sucks....
Sounds good! eom
HAVE A HAPPY FOURTH OF JULY EVERYONE!
I will be happy tomorrow to celebrate what unites us instead of what divides us lately.
And it will be very nice tomorrow to NOT have CLRB’s share price going down. LOL
More news; more price loses
On June 28, 2018, we issued a press release announcing that we will expand patient enrollment in the diffuse large b-cell lymphoma (DLBCL) cohort of our currently enrolling Phase 2 clinical trial of CLR 131. A copy of the press release is furnished as Exhibit 99.1 and is incorporated by reference herein.
Gravity sucks...
the life out of stocks priced under $1.
We need verifiable & positive CLR131 clinicical trial news to get this sow back over $1.
Nullification of a post as to form does not
Nullify its content:
The Globe Newswire PR from today states this:
“...Last month, Cellectar announced that the FDA also granted RPDD for CLR 131 for the treatment of neuroblastoma. If CLR 131 is approved by the FDA for either neuroblastoma or rhabdomyosarcoma, the rare pediatric disease designation may enable Cellectar to receive a priority review voucher. Priority review vouchers can be used by the sponsor to receive priority review for a future NDA or BLA submission, which would reduce the FDA review time from 12 months to six months. Currently, these vouchers can also be transferred or sold to another entity. Over the last 16 months, five priority review vouchers were sold for between $110 million to $150 million each.”...
What’s not to like about this development as a long CLRB stock holder?
Don’t believe everything one reads on the Internet is a good rule of thumb, however.