Proactiveinvestors USA & Canada Cellectar Biosciences https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Cellectar Biosciences RSS feed en Thu, 18 Jul 2019 16:30:54 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Cellectar Biosciences' stock flies after its multiple myeloma drug shows promising Phase 1 results ]]> https://www.proactiveinvestors.com/companies/news/220350/cellectar-biosciences--stock-flies-after-its-multiple-myeloma-drug-shows-promising-phase-1-results-220350.html Cellectar Biosciences Inc (NASDAQ:CLRB) stock soared Wednesday after it revealed promising results for its ongoing Phase 1 study of its refractory multiple myeloma treatment.

Investors cheered the news, sending the stock up nearly 20.2% to $2.74 in afternoon trading.

The independent Data Monitoring Company found Cellectar's CLR 131 drug safe and tolerable at the dosage level given to its current sample of patients with the white blood cell cancer.

READ: Cellectar Biosciences wins FDA Fast Track designation for multiple myeloma drug

The results demonstrated strong improvement over previous levels, including a 50% partial response rate, 50% minimal response rate, and 100% disease control rate among patients.

A partial response is defined as a decline in disease markers between 50% and 89.9%, according to the Myeloma Working Group while a minimal response indicates a decline between 25% and 49.9%.

Going forward, a slightly higher dosage will be given to a new sample of patients. Results from that group are expected in the fourth quarter of 2019.

Positive safety data

“We are very pleased to see continued positive safety and tolerability data in addition to enhanced efficacy from our ongoing Phase 1 dose escalation study for CLR 131,” said Cellectar Biosciences CEO James Caruso in a statement. “We are observing a clear dose response with greater and more prolonged median reductions in surrogate efficacy markers throughout the study safety evaluation period as compared to prior cohorts, along with an improved overall drug profile with our fractionated dosing regimen.”

Cellectar is a New Jersey clinical-stage biopharmaceutical company focused on developing and bringing to market cancer treatments. Its CLR 131 drug is designed to serve as the fourth or later option in treating blood cell cancers by delivering radiation directly and selectively to cancer cells.

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com

Follow him on Twitter @andrew_kessel

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Wed, 15 May 2019 12:45:00 -0400 https://www.proactiveinvestors.com/companies/news/220350/cellectar-biosciences--stock-flies-after-its-multiple-myeloma-drug-shows-promising-phase-1-results-220350.html
<![CDATA[News - Cellectar Biosciences wins FDA Fast Track designation for multiple myeloma drug ]]> https://www.proactiveinvestors.com/companies/news/220236/cellectar-biosciences-wins-fda-fast-track-designation-for-multiple-myeloma-drug-220236.html Cellectar Biosciences Inc (NASDAQ:CLRB) was awarded Fast Track designation by the Food and Drug Administration on Monday for its relapse/refractory multiple myeloma drug.

The New Jersey company’s CLR 131 drug is designed to combat blood cell cancers as the fourth or later treatment option by delivering radiation directly and selectively to cancer cells.

READ: Cellectar Biosciences soars as it plans to initiate Phase 1 study in pediatric cancer patients after FDA grants exemption

The drug is currently being evaluated in the CLOVER-1 Phase 2 trial, which is being conducted in 10 US cancer centers for patients with multiple myeloma and other blood cancers. It’s also a part of two ongoing Phase 1 trials.

Earning Fast Track designation gives Cellectar more facetime with the FDA to discuss its study design and clinical programs. Treatments may also be in line for a priority review of their New Drug Application.

“Fast Track designation furthers our efforts to expeditiously develop CLR 131 as a new, innovative therapy for patients with relapse/refractory multiple myeloma,” said CEO James Caruso. “Based on data in the initial patient cohort from our ongoing CLOVER-1 trial where patients showed a 30% response rate after receiving a single 25.0 mCi/m2 dose as a seventh line of therapy on average, we are optimistic that CLR 131 has the potential to provide a meaningful treatment option for these patients.”

CLR 131 earned orphan drug status from the FDA for multiple myeloma in 2014 and for neuroblastoma and rhabdomyosarcoma in 2018, giving the company a seven-year exclusive right to develop its treatment. 

Cellectar is a clinical-stage biopharmaceutical company focused on developing and bringing to market cancer treatments.

Shares rose nearly 2% Monday, and added nearly 2% more after the bell Tuesday to $2.33.

Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com

Follow him on Twitter @andrew_kessel

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Tue, 14 May 2019 09:24:00 -0400 https://www.proactiveinvestors.com/companies/news/220236/cellectar-biosciences-wins-fda-fast-track-designation-for-multiple-myeloma-drug-220236.html
<![CDATA[News - Cellectar Biosciences soars as it plans to initiate Phase 1 study in pediatric cancer patients after FDA grants exemption ]]> https://www.proactiveinvestors.com/companies/news/216774/cellectar-biosciences-soars-as-it-plans-to-initiate-phase-1-study-in-pediatric-cancer-patients-after-fda-grants-exemption-216774.html Cellectar Biosciences Inc (NASDAQ:CLRB) stock jumped Tuesday after it said the US Food and Drug Administration has granted an exemption to the “import alert” faced by the Centre for Probe Development and Commercialization (CPDC), linked to the use of Cellectar’s lead cancer candidate CLR 131.

The biopharma said the exemption will allow it to begin enrolling patients in its Phase 1 pediatric study for the treatment of relapsed or refractory solid tumors including neuroblastoma, lymphomas and malignant brain tumors.

READ: Cellectar Biosciences shares soar after its cancer drug receives Rare Pediatric Disease Designation

Shares of the Madison, Wisconsin-based company soared more than 12% to $3.07. 

Separately, Cellectar is already enrolling patients in its Phase 1 and Phase 2 multiple myeloma and select B-cell lymphoma studies of CLR 131 for its hematology investigational new drug application.

“We are grateful that the FDA has granted this additional exemption for CLR 131, which allows us to immediately initiate our pediatric clinical study in children battling life-threatening cancers,” said Cellectar Biosciences President and CEO, James Caruso. “These patients have a very poor prognosis and low rates of survival as a result of limited effective treatment options. Based on our preclinical and ongoing clinical studies, we are optimistic that CLR 131 has the potential to provide a meaningful treatment option for children suffering from cancers with high unmet medical needs.”

Phase 1 pediatric study of CLR 131

The Phase 1 open-label, dose-escalation study will evaluate the safety and tolerability of a single intravenous administration of CLR 131 in 30 children with cancers, including neuroblastoma, sarcomas, malignant brain tumors and lymphomas, including Hodgkin’s lymphoma.

The secondary objective is to identify the recommended Phase 2 dose of CLR 131 and to determine preliminary antitumor activity or treatment response to CLR 131 in children and young adults.

The company plans to initiate the Phase 1 study in seven pediatric cancer centers within and outside the United States.

In December 2014, the FDA granted orphan drug designation to CLR 131 for the treatment of multiple myeloma.

In September 2018, the biopharma’s cancer CLR 131 treatment also received Rare Pediatric Disease Designation from the FDA as a treatment for osteosarcoma, a rare pediatric cancer that begins in the cells that form bones.

The Rare Pediatric Disease Designation is granted for diseases that affect children from birth to 18 years old and affect fewer than 200,000 persons in the US.

The designation has been granted to CLR 131 in four pediatric cancers, including neuroblastoma, rhabdomyosarcoma and Ewing’s Sarcoma.

An RPDD can lead to a priority review voucher, which cuts down the FDA’s review time in half to six months.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Tue, 19 Mar 2019 10:34:00 -0400 https://www.proactiveinvestors.com/companies/news/216774/cellectar-biosciences-soars-as-it-plans-to-initiate-phase-1-study-in-pediatric-cancer-patients-after-fda-grants-exemption-216774.html
<![CDATA[News - Cellectar Biosciences shares soar after its cancer drug receives Rare Pediatric Disease Designation ]]> https://www.proactiveinvestors.com/companies/news/205039/cellectar-biosciences-shares-soar-after-its-cancer-drug-receives-rare-pediatric-disease-designation-205039.html Cellectar Biosciences Inc (NASDAQ:CLRB) shares jumped double digits after the biopharma’s cancer treatment received Rare Pediatric Disease Designation from the US Food and Drug Administration.

Shares of the Wisconsin-based company soared in Monday pre-market trading and continued climbing more than 14% to US$2.50 following the opening bell.

Its lead candidate CLR 131 is a treatment for osteosarcoma, a rare pediatric cancer that begins in the cells that form bones.

READ: InMed Pharmaceuticals looks to take cannabinoid-based research to the next level

The Rare Pediatric Disease Designation is granted for diseases that affect children from birth to 18 years old and affect fewer than 200,000 persons in the US.

“CLR 131 has demonstrated promise as an anticancer agent in preclinical and clinical settings, and we are working now to establish its impact on various rare and deadly pediatric cancers,” said John Friend, chief medical officer of Cellectar, in the company’s press release.

The designation has been granted to CLR 131 in four pediatric cancers, including neuroblastoma, rhabdomyosarcoma and Ewing’s Sarcoma.

An RPDD can lead to a priority review voucher, which cuts down the FDA’s review time in half to six months.

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Mon, 17 Sep 2018 09:35:00 -0400 https://www.proactiveinvestors.com/companies/news/205039/cellectar-biosciences-shares-soar-after-its-cancer-drug-receives-rare-pediatric-disease-designation-205039.html
<![CDATA[News - Cellectar Biosciences shares rollercoaster after one patient sees a 94% tumor reduction in its mid-stage trial ]]> https://www.proactiveinvestors.com/companies/news/200985/cellectar-biosciences-shares-rollercoaster-after-one-patient-sees-a-94-tumor-reduction-in-its-mid-stage-trial-200985.html Cellectar Biosciences Inc (NASDAQ:CLRB) shares jumped double digits after a single patient saw a dramatic improvement in her condition.

In a Phase 2 trial of its drug CLR 131, a patient with a rare type of cancer known as Waldenstrom macroglobulinemia saw a 94% reduction in the amount of tumor material in her body after two doses of the drug. Four of the five targeted tumors were completely resolved.

READ: Zogenix shares pop on impressive Phase 3 results for epilepsy drug

“CLR 131 has shown good clinical response in LPL as well as other hematologic indications and could provide an excellent addition to the treatment armamentarium,” said Sikander Ailawadhi, the patient’s treating physician, in a press release.

However, one patient’s results may not be indicative of the trial as a whole. The mid-stage trial intends to enroll a total of 80 participants to continue studying the drug and is expected to end in March 2019.

As investors began to mull over the results, shares fell nearly 40% to US$7.31 from an intraday high of US$12.22 earlier in the trading day.

Shares of the Wisconsin-based biotech were trading slighty lower to US$7.46 heading into Tuesday's close.

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Tue, 17 Jul 2018 15:09:00 -0400 https://www.proactiveinvestors.com/companies/news/200985/cellectar-biosciences-shares-rollercoaster-after-one-patient-sees-a-94-tumor-reduction-in-its-mid-stage-trial-200985.html
<![CDATA[News - Cellectar Biosciences jumps after positive tumor study results ]]> https://www.proactiveinvestors.com/companies/news/127168/cellectar-biosciences-jumps-after-positive-tumor-study-results-127168.html Cellectar Biosciences Inc (NASDAQ:CLRB) shares jumped in early deals after revealing positive findings from a preliminary tumor-targeting study

It told investors that the study has shown the company’s prototype paclitaxel chemotherapeutic conjugate, referred to as CLR 1602, may be up to 30 times more tumor selective in comparison to free paclitaxel.

The company added that it also displayed an extended plasma half-life relative to free paclitaxel, and noted that the greater half-life may in part explain the higher tumor uptake.

“The study results are a significant signal in the development of our paclitaxel Phospholipid Drug Conjugates (PDCs),” said Jim Caruso, Cellectar chief executive.

“More importantly, it represents further validation of our entire CLR CTX program.”

He added: “These data clearly confirm our ongoing assertion that delivery of chemotherapeutics with our PDC platform may provide superior tumor cell targeting than chemotherapeutics alone, converting non-targeted chemotherapeutics into targeted cytotoxic agents.

“We anticipate conducting future studies and evaluating against other comparators, such as Abraxane.”

Cellectar highlighted that the in vivo study was designed to assess the pharmacokinetics, absorption, and distribution after a single intravenous administration of CLR 1602.

The Nasdaq stock was up 66 cents, 20.85%, to trade at US$3.99 each – and earlier changed hands as high as US$4.58.

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Wed, 15 Jun 2016 09:55:00 -0400 https://www.proactiveinvestors.com/companies/news/127168/cellectar-biosciences-jumps-after-positive-tumor-study-results-127168.html
<![CDATA[News - Cellectar shares extend last Friday's 400% surge ]]> https://www.proactiveinvestors.com/companies/news/126285/cellectar-shares-extend-last-friday-s-400-surge-126285.html Cellectar Biosciences Inc (NASDAQ:CLRB) shares advanced by 20% on Monday - extending in small measure on the 400% leap seen on Friday.

Investors became excited last week that Cellectar's phospholipid ether analogs as cancer-targeting drug vehicles had received their US Patent and Trademarks.

The latest surge in the share price followed news that Cellectar chief executive, Jim Caruso, would be presenting at the 2016 Marcum MicroCap Conference in New York on 2 June.

Caruso intends to use the conference as a platform to publicise the group's phospholid drug conjugate platform.

The shares were last seen up 19.6% at $4.13.

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Mon, 23 May 2016 15:27:00 -0400 https://www.proactiveinvestors.com/companies/news/126285/cellectar-shares-extend-last-friday-s-400-surge-126285.html