New Drug Approvals

Home » Phase3 drugs » Phase3 Rindopepimut ,CDX-110 Celldex Therapeutics’ brain cancer vaccine

Phase3 Rindopepimut ,CDX-110 Celldex Therapeutics’ brain cancer vaccine

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Recent Posts

Blog Stats

  • 3,949,251 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,725 other followers

add to any

Share

Glioblastoma (GB) - Photo via Pharmapolis
http://clinicaltrials.gov/ct2/show/NCT01480479

MAR 2013

Rindopepimut

Immunotherapeutic vaccine called Rindopepimut showed positive results in prolonging survival in patients with newly diagnosed EGFRvIII-positive glioblastoma (GB), one of the most aggressive forms of brain cancer

Celldex Therapeutics’  brain cancer vaccine, rindopepimut, also known as CDX-110, targets EGFRvIII, an activated mutation of the epidermal growth factor receptor (EGFR). This mutation is found in about 31% of cases of glioblastoma multiforme, a form of fast-growing brain cancer and the most common type of primary brain tumor. It can contribute to tumor growth, and is linked with poor long-term survival. It is not seen in normal tissue.

In the ACT III Phase II trial, which involved people with newly diagnosed EGFRvIII-positive glioblastoma, 65 patients were given rindopepimut in combination with standard-of-care treatment (temozolomide), after having undergone surgery and standard chemotherapy and radiation therapy.

focus on is Rindopepimut, an immunotherapy treatment that targets EGFRvIII. As it’s not found at significant levels in normal tissues but expressed in 30ish% of primary glioblastoma, it’s an ideal target that has produced promising results to date. The drug candidate has shown consistent benefit for patients across three phase 2 studies- that’s no fluke! It’s currently in a global phase 3 trial in patients with newly diagnosed glioblastoma with results due in a couple years

Phase 3 Study of Rindopepimut in Patients With Newly Diagnosed Glioblastoma (ACT IV)
A Phase 3 Study of Rindopepimut in Patients with Newly Diagnosed Glioblastoma
Design: Phase 3, double-blind, study of rindopepimut compared with KLH control
Status: Currently enrolling at multiple centers in the US; additional centers outside the US planned to be activated in 2012

ABOUT THE CLINICAL TRIAL

This 2-arm, randomized, Phase 3 study will investigate the efficacy and safety of the addition of rindopepimut to the current standard of care, temozolomide, in patients with recently diagnosed EGFRvIII positive glioblastoma. All patients will be administered temozolomide. Half the patients will be randomly assigned to receive rindopepimut (given along with GM-CSF as a vaccine adjuvant) and half the patients will be randomly assigned to receive a keyhole limpet hemocyanin (KLH). Patients will be treated in a blinded fashion (neither the patient nor the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.

All patients enrolled in the study will be closely monitored to determine if their cancer is responding to treatment and for any side effects that may occur.


5 Comments

  1. medchemnintabelle says:

    Reblogged this on nintabelle.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,725 other followers

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 LIFE SCIENCES 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 PLUS year tenure till date June 2021, 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, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, 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 33 lakh plus views on New Drug Approvals Blog in 233 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

Personal Links

View Full Profile →

TWITTER

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: