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Reslizumab

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Reslizumab(CINQUIL) is a humanized monoclonal antibody
targeted against IL-5 that is being developed by Cephalon for the
treatment of eosinophilic asthma. In September 2010, Cephalon
indicated that it hopes to file a BLA in 2013, focusing on this subset of
severe asthmatics. Such patients are ca. 30% of the asthmatic population,
with the 750,000 patients in the United States suggested to offer the potential for peak market sales of $1 billion. However, previous

attempts to develop recombinant IL-5 antagonists for the treatment of asthma saw very disappointing clinical results with both mepolizumab

(GlaxoSmithKline) and reslizumab (Schering-Plough and Celltech).
Schering-Plough (now Merck) had been developing reslizumab in
partnership with Celltech (now UCB), utilizing the latter’s antibody
technology, but terminated development in 2002 after disappointing
clinical results. The rights were acquired by Ception Therapeutics in
2007, with development reinitiated for both pediatric eosinophilic
esophagitis and eosinophilic asthma. Cephalon acquired an option to
acquire Ception in January 2009 and exercised this option in April 2010
despite unpromising results in the Phase II/III study of reslizumab in
pediatric eosinophilic esophagitis patients.
In its November 2009 R&D presentation, Cephalon presented data
(from Schering-Plough) showing that reslizumab treatment of asthmatics
results in a sustained suppression of eosinophil levels; the protocols
employed in the Phase II/III study in pediatric eosinophilic esophagitis
and a Phase II study in eosinophilic asthma were described. The Phase
III study in asthmatics has yet to commence, but a 190-patient openlabel Phase III extension study in eosinophilic esophagitis is ongoing.
The Phase II/III study showed no discernable symptom improvement
despite suppression of eosinophil levels at all three doses tested (see
Walsh 2010).43 The outcome of the 106-patient Phase II study, in
February 2009, in asthmatics prompted Cephalon to acquire Ception.
Reslizumab treatment produced significant improvement in lung
function and reduced airway inflammation.
Reslizumab is currently the most advanced of three anti–IL-5monoclonal antibodies in development, but the 2013 submission date for a BLA seems optimistic given that Phase III studies have yet to start.

Mepolizumab is now in Phase II studies for the treatment of severe

asthma and nasal polyposis (having previously been filed for approval
in Europe for the treatment of hypereosinophilic syndrome), but the
filing was withdrawn and development for that indication discontinued
in late 2009. MedImmune and Kyowa Hakko Kirin’s benralizumab has
successfully completed a Phase IIa study in asthma with data presented
in September 2010, and a 108-patient study in asthma was completed
in October 2010. A similar-size Phase II study in COPD commenced in
November 2010.

Reslizumab is a humanized monoclonal antibody intended for the treatment of eosinophil-meditated inflammations of the airwaysskin and gastrointestinal tract.[1] As of September 2009, the drug is undergoing Phase II/III clinical trials.[2]

Eosinophils are important proinflammatory cells that make a major contribution to the inflammation seen in allergic diseases including asthma. Interleukin-5 is central to eosinophil maturation, release from the bone marrow, and subsequent accumulation, activation, and persistence in the tissues. Reslizumab (Cinquil™) is a humanized monoclonal antibody with potent interleukin-5 neutralizing effects, which represents a potential treatment for poorly controlled eosinophilic asthma. This review will consider the current status of the clinical development of reslizumab for asthma and in other inflammatory diseases with a marked eosinophilic component.

  1. Walsh, GM (2009). “Reslizumab, a humanized anti-IL-5 mAb for the treatment of eosinophil-mediated inflammatory conditions”. Current opinion in molecular therapeutics11 (3): 329–36. PMID 19479666.
  2.  ClinicalTrials.gov

4 Comments

  1. medchemnintabelle says:

    Reblogged this on medchemnintabelle.

  2. I every time spent my half an hour to read this weblog’s posts every day along with a cup of coffee.

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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