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Caladrius Biosciences Inc(NASDAQ:CLBS)

Entro i prossimi 30 giorni circa, gli occhi sono puntati sull'eventuale finalizzazione del partner (globale o locale) per il CLI Trial in Japan. Di fondamentale importanza l'upfront payment, anche in considerazione del fatto che ciò consentirebbe a CLBS di negoziare un eventuale joint venture in Europa con Hitachi in condizioni di maggior, seppur relativa, forza.

Per chi volesse inoltre approfondire con modelli, secondo l'ultimo 10K, questi sono i numeri dei pazienti potenzialmente beneficiari della terapia per la CLI divisi per regione:

Japan: 21.000;
Europe: 100.000;
USA: 20.000.

Questo è probabilmente il motivo per il quale CLBS è in contatto sia con partner locali (Japan), sia con partner globali, soprattutto visto il potenziale in EU.
 
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Caladrius Biosciences Announces First Subject Treated in CLBS03 Type 1 Diabetes Phase 2 Trial

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Caladrius Biosciences, Inc.
1 hour ago

GlobeNewswire






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BASKING RIDGE, N.J., March 29, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences (CLBS), (�gCaladrius�h or the �gCompany�h), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces treatment of the first subject in The Sanford Project: T-Rex Study. The T-Rex Study is a Phase 2 trial of Caladrius�f product candidate CLBS03 (autologous expanded regulatory T cells, or Tregs) for the treatment of recent-onset type 1 diabetes (T1D) in adolescents.






The prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 will enroll 111 subjects age 12 to 17 in two cohorts (18 subjects followed by 93 subjects) and is being conducted in collaboration with Sanford Research, a subsidiary of Sanford Health. Subjects will be randomized into one of three groups and will receive either a high dose of CLBS03, a low dose of CLBS03 or placebo. Investigational product will be administered as a single infusion and the subjects will be evaluated over the course of 2 years. The key endpoints for the trial are the standard medical and regulatory endpoints for a type 1 diabetes trial and include preservation of C-peptide, an accepted measure for pancreatic beta cell function; insulin use; severe hypoglycemic episodes; and hemoglobin A1c level in comparison to placebo.

An initial safety analysis of the data and early analysis of immunological biomarkers will occur after the first cohort of 18 subjects has completed the three-month post-treatment visit. Pending review of the data from the first cohort and recommendation of the independent Data Safety Monitoring Board, a second cohort of 93 subjects will be enrolled. An interim efficacy analysis will occur after approximately 50% of all subjects reach the six-month follow-up milestone. Sanford Research will provide and cover the costs of two initial clinical trial sites which are expected to enroll the first cohort of subjects. Additional sites could be added to the study to facilitate timely completion of enrollment of the second cohort.

�gThe initiation of enrollment of this trial marks an important milestone for our investigational type 1 diabetes program and moves this program into the clinical development stage,�h said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. �gAchieving this milestone supports our goal to create shareholder value by developing select, early-stage, highly-promising cell therapy candidates to proof-of-concept as a complement to our robust, revenue-generating cell therapy development and manufacturing services business. We look forward to presenting the initial safety analysis on the first 18 subjects by early 2017.�h

The scientific basis for this program stems from the use of Tregs to treat diseases caused by imbalances in an individual's immune system, such as T1D. This novel approach seeks to restore immune balance by enhancing Treg cell number and function. Tregs are a natural part of the human immune system and regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, it is thought that deficient Treg activity permits the T effector cells to attack the body's own beneficial cells, and in the case of T1D, insulin-producing pancreatic beta cells.

�gWe were encouraged by the findings of our Phase 1 study indicating safety and tolerability in adult patients and are now excited to begin this Phase 2 program to further assess safety and to evaluate the efficacy of this novel therapy,�h said Stephen Gitelman, MD, Professor of Clinical Pediatrics at the University of California, San Francisco and Chair of the T-Rex Study Executive Steering Committee.




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�gIf proven effective, such a therapy could have a profound impact on the lives of tens of thousands of young people suffering from diabetes, for whom there are currently no curative treatments but only lifelong insulin therapy,�h said Douglas W. Losordo, MD, Senior Vice President, Clinical, Medical and Regulatory Affairs and Chief Medical Officer at Caladrius.

�gSanford Health has long been a leader of innovation and research,�h stated David Pearce, PhD, president of Sanford Research. �gSanford is driven to help advance research to cure type 1 diabetes. That is why we were committed to being at the forefront of bringing The Sanford Project: T-Rex Study to patients.�h
 
+ 4 un giorno - 4 un altro... bah...
 
Caladrius Reaches Agreement with Japanese Regulators on Development Plan for CD34 Cell Therapy for Critical Limb Ischemia

Positive Phase 2 trial result will qualify for early conditional approval - Company seeks partner to execute plan

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Caladrius Biosciences, Inc.
April 18, 2016 7:30 AM

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BASKING RIDGE, N.J., April 18, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a leading cell therapy company combining an industry-leading development and manufacturing services provider with a select therapeutic product pipeline, announces that the Japanese Pharmaceutical and Medical Devices Agency’s (PMDA) thirty-day review period of the Company’s Clinical Trial Notification (CTN) for a pivotal Phase 2 trial investigating the Company’s CLBS12 product candidate, a CD34 cell therapy for critical limb ischemia (CLI), has now passed without further comment from the PMDA. Accordingly, Caladrius is allowed to proceed with the trial when ready. The Company is seeking a partnership in order to pursue this trial, and is currently in advanced discussions with potential licensing partners. Pending consummation of a partnering agreement, Caladrius expects that the pivotal trial could initiate as early as late 2016.






The Company believes the study design is sufficient to achieve conditional approval for CLBS12 in Japan for the treatment of CLI. The agreed trial is a 35-patient Phase 2, prospective, randomized, controlled, multicenter study in patients with no-option CLI conducted in Japan. Those patients randomized to treatment will be dosed with autologous G-CSF-mobilized peripheral blood-derived CD34+ cells (CLBS12) through intramuscular injection in addition to standard of care. Patients randomized to the control arm will receive standard of care pharmacotherapy alone.

“We are pleased that our interactions with the PMDA have led to the design of a relatively small and, we believe, low risk trial that could significantly advance CLBS12 and the Company’s CD34 asset,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “We look forward to achieving a partnership to enable the launch of this pivotal Phase 2 trial in Japan. CLI is just the entry-point to explore the broader applicability of the CD34 platform therapy, which could potentially be effective in the treatment of chronic heart failure or dilated cardiomyopathy.”

Caladrius has decided to aggressively pursue this registration pathway in Japan largely due to the recent Regenerative Medicine Law passed in November 2014. The legislation expedites the development and commercialization of regenerative medicine therapies and grants conditional approval for regenerative medicines that demonstrate safety and the likelihood for efficacy.

“Based on the substantial clinical data from four prior trials in critical limb ischemia and claudication, we believe that CD34 cell therapy is not only safe, but can help improve quality of life and potentially treat patients with this serious and life-threatening condition, which we intend to demonstrate through this pivotal study,” said Dr. Atsuhiko Kawamoto, principal investigator for this pivotal Phase 2 trial for CLBS12.

Dr. Kawamoto is the Director of the Unit of Regenerative Medicine and Leader of the Vascular Regeneration Research Group at the Institute of Biomedical Research and Innovation in Kobe, Japan. He is also the Vice Director of the Translational Research Informatics Center at the Foundation for Biomedical Research and Innovation.
 
Caladrius Biosciences Reports 2016 First Quarter Financial Results

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Caladrius Biosciences, Inc.
13 hours ago

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Total Quarterly Revenues Increase 136% versus Prior Year


Conference Call Begins Today at 5:00 pm Eastern Time

BASKING RIDGE, N.J., May 05, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius”), a cell therapy company combining an industry-leading development and manufacturing services provider (through its subsidiary, PCT, LLC a Caladrius CompanyTM (“PCT”)) with a select therapeutic development pipeline, announces financial results for the three months ended March 31, 2016.

Financial and Business Highlights
•Achieved total revenues of $7.5 million for the first quarter of 2016, up 136% compared with $3.2 million in the first quarter of 2015 driven by higher Clinical Services revenue at PCT.
•Entered into a global collaboration and license agreement with Hitachi Chemical Co. America, Ltd. and Hitachi Chemical Co., Ltd. (collectively, “Hitachi Chemical”), selling a 19.9% equity stake in PCT for $19.4 million and licensing PCT’s cell therapy technology and know-how for certain Asian territories for $5.6 million and future royalties.
•Enrolled the first patient in The Sanford Project: T-Rex Study, a Phase 2 trial of CLBS03 (autologous expanded regulatory T cells, or Tregs) for the treatment of recent-onset type 1 diabetes (T1D) in adolescents.
•Received classification from the European Medicines Agency (EMA) of CLBS03 as an Advanced Therapeutic Medicinal Product (ATMP).
•Reached agreement with Japanese regulators on a Phase 2 development plan that could qualify for early conditional approval for CD34 cell therapy as a treatment for critical limb ischemia.

Management Commentary

“The significant revenue growth at PCT along with Hitachi Chemical’s implied valuation of our subsidiary further support our strategy to focus on growth opportunities in the emerging cell therapy manufacturing market,” stated David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “In addition to validating our expertise and know-how, the strategic partnership with Hitachi Chemical strengthens our financial position with $25 million in non-dilutive capital.

“We will continue to leverage the significant momentum in the regenerative medicine and cell therapy industries to grow our PCT business. We believe that the quality of PCT’s services, the increasing number of clinical trials planned and underway and the number of clinical programs nearing commercialization will provide a healthy platform for growth at PCT throughout 2016 and beyond.

“We are delighted that patients are being enrolled in the Sanford Project: T-Rex Study. Sanford Research, a leader of innovation and research in T1D, will provide and cover the costs of two initial clinical trial sites, which are expected to enroll most of, if not all of, the first cohort of subjects. After this first cohort has completed the three-month post-treatment visit, an interim safety analysis and early analysis of immunological biomarkers will be conducted. With positive results, more sites will be added to facilitate the timely enrollment of the second cohort of this important proof-of-concept study designed to show that CLBS03 can preserve pancreatic beta cell function and lower insulin use in adolescents with recent-onset T1D,” concluded Dr. Mazzo.

First Quarter Financial Highlights

Total revenues for the first quarter of 2016 increased 136% to $7.5 million compared with $3.2 million for the first quarter of 2015. Gross margin on revenues was 17% in the first quarter of 2016, compared with gross margin of negative 6% in the first quarter of 2015.

Research and development (R&D) expenses for the first quarter of 2016 decreased 14% to $5.9 million compared with $6.8 million for the first quarter of 2015. The decrease was primarily related to lower costs subsequent to the discontinuation of Caladrius’ Intus Phase 3 clinical trial as well as decreased costs associated with our ischemic repair platform, compared to the prior year periods. These decreases were partially offset by an increase in expenses related to the initiation of The Sanford Project: T-Rex Phase 2 Study in type 1 diabetes, as well as one-time restructuring costs for severance and asset impairments.

Selling, general and administrative (SG&A) expenses decreased 42% to $6.5 million for the first quarter of 2016 compared with $11.1 million for the same period in 2015, which included expenses associated with executive management changes including one-time new hire compensation-related costs as well as separation-related costs. Equity-based compensation expenses were also significantly lower in the first quarter of 2016 compared to the prior year period.

The operating loss for the first quarter of 2016 was $11.1 million compared with an operating loss of $18.1 million for the first quarter of 2015, reflecting higher gross margin on sales, and lower R&D and SG&A expenses.

Total net loss for the first quarter of 2016 was $12.0 million, and $0.21 per share for Caladrius stockholders, compared with a net loss for the first quarter of 2015 of $19.2 million and $0.51 per share.
 
Caladrius Biosciences Receives Orphan Drug Designation for CLBS03 to Treat Type 1 Diabetes



BASKING RIDGE, N.J., May 12, 2016 -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (“PCT”) with a select therapeutic development pipeline, announces today that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) for the treatment of recent-onset type 1 diabetes (“T1D”) was granted orphan-drug designation by the US Food and Drug Administration (“FDA”) for the treatment of type 1 diabetes mellitus with residual beta cell function.

Orphan drug designation provides certain exclusivity benefits, tax credits for certain research, longer exclusivity and a waiver of the New Drug Application user fee. The designation is made to promote safe and efficacious products for the treatment of rare diseases. T1D with residual beta cell function is recognized by the FDA as an orphan disease, usually defined as a condition that affects fewer than 200,000 people (prevalence) nationwide.

The scientific basis for this therapeutic stems from the use of Tregs to treat autoimmune diseases caused by T cell imbalances in an individual's immune system. This novel approach seeks to restore immune balance by enhancing Treg cell number and function. Tregs are a natural part of the human immune system and regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, it is thought that deficient Treg activity permits the T effector cells to attack the body's own beneficial cells, and in the case of T1D, insulin-producing pancreatic beta cells.

“Obtaining orphan drug designation is a key step in our regulatory and development strategy for CLBS03,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “Coupled with the progress we are making in advancing the product through to clinical milestones, we believe that this will make CLBS03 an even more attractive opportunity for a potential partner.”

About The Sanford Project: T-Rex Study

The study is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for type 1 diabetes mellitus with residual beta cell function in approximately 111 subjects age 12 to 17 in two cohorts (18 subjects followed by 93 subjects). The study is being conducted in collaboration with Sanford Research, a subsidiary of Sanford Health. Subjects will be randomized into one of three groups and will receive either a high dose of CLBS03, a low dose of CLBS03 or placebo. The key endpoints for the trial are the standard medical and regulatory endpoints for a type 1 diabetes trial and include preservation of C-peptide, an accepted measure for pancreatic beta cell function; insulin use; severe hypoglycemic episodes; and glucose and hemoglobin A1c levels.
 
BASKING RIDGE, N.J. (May 26, 2016) – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a select therapeutic development pipeline, announces that it has licensed to AiVita Biomedical, Inc. (“AiVita”) the exclusive global rights to its tumor cell/dendritic cell technology for the treatment of ovarian cancer. In return, Caladrius will receive certain development milestone payments as well as royalties on sales of any commercial product. This transaction supports the Company’s strategy to monetize non-core assets. Under the license agreement AiVita will assume responsibility for all costs to develop a product using the licensed intellectual property, including the maintenance costs of the associated intellectual property.

The license contribute's to AiVita's intellectual property protection fof its next generation immunotherapy targeing cancer stem cells. AiVita intends to begin a Phase 2 clinical trial to evaluate the efficacy of its novel approach in ovarian cancer in 2016. To facilitate these clinical objectives, AiVita has also assumed a sublease of the Company’s former Irvine, California facility. This sublease obligation will cover for the remainder of the lease term all cash obligations of Caladrius with respect to the rent and overhead of the Irvine facility.

“Licensing this technology to AiVita is another step forward in streamlining our strategic focus and reducing our operating expenses while monetizing non-core assets through royalty and other milestone-driven transactions,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “This agreement adds to the one signed in February 2016 whereby we licensed to AiVita exclusive global rights to our cell-derived dermatological technology for topical skin applications.”
 
Caladrius Subsidiary, PCT, to Manufacture Phase 3 Cell Therapy Product for Kiadis Pharma

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Caladrius Biosciences, Inc.
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BASKING RIDGE, N.J., June 21, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT, LLC, A Caladrius Company or “PCT”) with a select therapeutic development pipeline, today announces that PCT has expanded its relationship with Kiadis Pharma (Euronext Amsterdam:KDS) (Euronext Brussels:KDS) (“Kiadis”), by entering into an agreement for the manufacturing of cell therapy product for United States and Canada clinical trial sites for a Phase 3 trial of Kiadis’ lead product, ATIR101™, for the treatment of blood cancers.






To date, PCT has provided engineering and process development services for Kiadis which included optimizing its manufacturing process to incorporate functionally closed processing. Work is currently underway at PCT’s Allendale, New Jersey facility to expand its clean room capacity by 60% and to develop and implement cell therapy specific pharmaceutical grade quality systems.

“We are pleased to select PCT as our contract manufacturing organization in the United States,” said Manfred Rüdiger, PhD, Chief Executive Officer of Kiadis. “The manufacture and supply of study medication for our Phase 3 clinical trial with ATIR101™ in the United States and Canada is a critical component to the successful and smooth running of our clinical study and having a partner who is well established and highly experienced, like PCT, is very important. PCT has been an excellent advisor and provider of process development to Kiadis in the past and we look forward to leveraging those efforts as we begin to broaden the activities of Kiadis in the United States.”

“We are pleased to expand our relationship with Kiadis to help bring new cell therapies to patients in need. Our Kiadis partnership is an excellent example of PCT’s growth strategy in motion – initiation of process and manufacturing development partnerships that subsequently expand to clinical manufacturing projects. Our strategy is for our partnerships to culminate, upon regulatory approval of client products, with commercial-scale manufacturing and advancement towards the cell therapy factory of the future,” said Robert A. Preti, PhD, President of PCT, and Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius Biosciences. “A growing number of cell therapy developers are partnering with PCT to take advantage of our quality, scalable, innovative, reliable, and cost-efficient manufacturing platforms and services to advance commercialization of cellular therapies.”

About Kiadis Pharma

Kiadis Pharma is focused on cell-based immunotherapy products for the treatment of blood cancers and inherited blood disorders. The Company’s products have the potential to address the risks and limitations connected with allogeneic hematopoietic stem cell transplantation (HSCT), namely Graft-versus-Host-Disease (GVHD), cancer relapse, opportunistic infections and limited matched donor availability. The Company believes that HSCT could become a first-choice treatment for blood cancers, inherited blood disorders and possibly autoimmune diseases and solid organ transplantations.




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In April 2016, the Company reported positive Phase II results with its lead product ATIR101™ in patients with blood cancer. The data showed that ATIR101™ significantly reduced Transplant Related Mortality and significantly improved Overall Survival. In addition, ATIR101™ did not elicit grade III-IV GVHD in any patient. ATIR101™ has been granted Orphan Drug Designations both in the US and Europe. The Company’s second product candidate, ATIR201™, addresses inherited blood disorders with an initial focus on thalassemia, a disease which results in destruction of red blood cells in patients. ATIR201™ is expected to enter Phase I/II clinical development in the second half of 2016.

Kiadis Pharma, based in Amsterdam, The Netherlands, was granted an Advanced Therapy Medicinal Product (ATMP) certificate for manufacturing quality and non-clinical data by the European Medicines Agency (EMA). The Company’s shares are listed on Euronext Amsterdam and Euronext Brussels. For more information visit www.kiadis.com
 
..da tenere d'occhio dopo il risveglio
 
...sempre da tenere d'occhio. un saluto
 
...io sempre dentro...secondo me è destinata a fare un balzo e spesso prima di fare un balzo gli fanno fare un bel giro al ribasso, pericolosa solo sotto i 0,50 :o
 
Ecco ...................................................................................................................

:bye:
 
r/s e fast track designation
 
Primo passo verso quota 500$:

BASKING RIDGE, N.J., July 28, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider, PCT, with a select therapeutic development pipeline, announces today that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of type 1 diabetes mellitus (TID), making it the first known therapeutic candidate for treatment of T1D to receive the designation. CLBS03 has received Orphan Drug designation from the FDA as well as Advanced Therapeutic Medicinal Product (ATMP) classification from the European Medicines Agency. CLBS03 is currently being studied in a landmark Phase 2 clinical trial in collaboration with Sanford Health, The Sanford Project: T-Rex Study, which is expected to complete enrollment of the first defined cohort of 18 patients in the coming weeks.


Fast Track is a process designed to facilitate the development and expedite the review of drugs, biologics or treatments for serious conditions, thereby filling unmet medical needs. Through the Fast Track program, a product may be eligible for priority review at the time of a Biologic License Application (BLA) or New Drug Application (NDA) filing and may also be eligible to submit completed sections of the BLA/NDA on a rolling basis before the complete application is submitted. These expedited processes can significantly cut down the development time and cost associated with bringing a therapy to market. Furthermore, the therapy's sponsors are eligible for more frequent written communication and meetings with the FDA, the benefit of which may be to foster a pivotal study design which more closely meets the FDA’s needs, thereby creating a more efficient and rapid pathway to approval.

The scientific basis for treating T1D with CLBS03 derives from the use of Tregs to treat autoimmune diseases caused by imbalances in an individual’s immune system. This innovative approach seeks to restore immune balance by enhancing Treg cell number and function. Tregs are a natural part of the human immune system and regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, deficient Treg activity permits the T effector cells to attack the body’s own beneficial cells, for example, insulin-producing pancreatic beta cells in the case of T1D.

CLBS03 is a personalized, autologous medicine consisting of each patient’s own Tregs, which have been expanded in number and functionally enhanced by a proprietary method developed by a collaboration between PCT and the University of California, San Francisco. The program is supported by promising published early clinical work conducted by respected leaders in the area of T regulatory cell science. Two Phase 1 clinical trials of this technology in T1D patients demonstrated safety and tolerance, feasibility of manufacturing, infused Treg persistence and an early indication of efficacy1,2. In particular, one of those trials provided supportive evidence of the utility of Tregs for T1D in pediatric patients 8 to 16 years of age with new onset T1D2. In that open label study, the authors reported that treatment with expanded autologous Tregs preserved function of pancreatic beta cells and reduced the need for exogenous insulin in the majority of patients treated.

“Obtaining Fast Track designation is a key milestone in our regulatory and development strategy for CLBS03. It underscores the great need for innovative treatments, such as CLBS03, in the treatment of T1D and allows for the acceleration of its development,” said David J. Mazzo, PhD, Chief Executive Officer of Caladrius. “We are making excellent progress advancing the U.S.-based Phase 2 clinical program of CLBS03 to treat T1D and look to complete enrollment of the first cohort of 18 patients in the coming weeks. This, coupled with our Orphan Drug and Fast Track designations, should make CLBS03 an even more attractive opportunity for a potential partner.”
 
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