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PMPs in clinical trials and advanced PMIPs - Research findings first presented at FinMed 2006, on 30th March 2006 - table as of July 2011. - Being updated Mar. '14

with thanks to Professor Julian K-C Ma, Francois Arcand and Dr Ulrich Steiner - © Brian Marshall, MolecularFarming.com - 2006 ---->


Research findings summary
1] From 1995 - 2006 the total amount of land used for every PMP trial done outdoors was less than 1200 acres ( an average US farm)
2] By 2015 - even with 40 approved PMP drugs with $1bn markets each, land use will be less than 40,000 acres - less than 50 farms.
3] Molecular Farming of PMPs is "pharmaceutical gardening", and has little in common with food agriculture
4] PMIPs have the potential to have more significant land use than PMPs, especially in the area of Biofuels.
5] On examination of PMIP products and regulation stage achieved so far, major growing in the 1,000,000+ acres scale is extremely unlikely before 2013. ( Molecular Farming of PMIPs will not be comparable to any major Global food / feed / fibre production in the near term )

During my initial research I have found that PMPs are in development for almost all major human diseases and conditions, including
Alzheimer's disease , Anthrax, Arthritis , Cancer, Chronic obstructive pulmonary disorder (COPD), Crohn's disease, Cystic Fibrosis, Diabetes, Heart Disease, Hepatitis B, Hepatitis C, HIV, Influenza, Iron deficiency, Kidney Disease, Measles, Multiple sclerosis, Non-Hodgkin's Lymphoma, Obesity, SARS and Spinal Cord Injuries.
Animal / poultry vaccines and medicines are also in development for diseases like Avian flu, Coccidiosis, Fowl pest, Parvovirus and Rabies



Plant made pharmaceuticals - Product status with regard to clinical trials as of July 11 - being updated March 2014
Company / Institution Plant used Product Indication Clinical Stage Reached
Meristem
Therapeutics
(liquidated '08)
Maize Gastric lipase Cystic fibrosis Phase 2 (x 2 "unformulated"
and "formulated")

Maize Lactoferrin Gastrointestinal disorders Phase 1
  Maize Collagen Reconstructive surgery Pre-clinical
Planet
Biotechnology
Tobacco slgA "CaroRx" Prevention of tooth decay Phase 2 but already granted an
EU licence as a medical device
Seeking EU. distribution partner.
  Tobacco ICAM1 / Rhinovirus
prophylactic
receptor for common cold Phase 2
Prodigene Maize Lt-B vaccine Traveller's diarrhoea Phase 1 complete - not ongoing
(taken over) Maize TGE vaccine Piglet gastroenteritis Phase 1 complete - not ongoing
  Maize Avidin Diagnostic use Available in Sigma catalogue '07
  Maize Trypsin Wound care / insulin
manufacture
Available in Sigma catalogue '07
  Maize Aprotinin Non clinical use No longer in Sigma catalogue
  Maize GUS Non clinical use No longer in Sigma catalogue
LSBC
(bankruptcy 2011)
Tobacco Vaccine Non-Hodgkin's
lymphoma
Phase 1 successful in 2002
  Tobacco Vaccine Feline Parvovirus "very advanced" - Status confidential
  Tobacco Aprotinin Non-clinical use Was in Sigma catalogue in 2005
Bayer Innovation Tobacco Anti-idiotype IgG
antibodies
Non-Hodgkin's
lymphomas
Phase 1 trial successful in 2013.
Icon Genetics -
(divested from Bayer
)
Tobacco Vaccine Non-Hodgkin's
Lymphoma
Phase 1 trial successful in 2014
Arizona State Univ. Potato Vaccine E.Coli Phase 1
  Potato Vaccine Hepatitis "B" Phase 1
  Potato Vaccine Norwark virus Phase 1
  Tobacco Vaccine Norwark virus Phase 1 / 2
  Undisclosed Oral Vaccine Undisclosed Phase 1 planned start mid '07
Ventria Biosciences Rice Lactoferrin Infant formula enhancer On sale to infant formula makers
  Rice Lactoferrin cell culture media Available from company
  Rice Lysozyme Undisclosed Undisclosed
  Rice Lysozyme For research purposes Available from company
Biolex
(Bankruptcy 2012)
Lemna Alpha
Interferon
Hepatitis "B" & "C"
and Cancer
Phase 2b ( x2 trials - "480" and
"formulated dose" )
  Lemna Recombinant plasmin Fibrinolytic "Clot-buster" Phase 1 ready
  Lemna Anti-CD20 mAb Non-Hodgkin's
lymphomas
Pre-clinical
Cobento AS
(formerly
Cobento Biotech AS)
Aribidopsis Human
Intrinsic
Factor
Vitamin B12 deficiency Approved Coban product launched.
Successful 37 patient clinical trial
cGMP production certified
  Aribidopsis Transcobalamin Diagnostic / research Available from company
Dow Agrisciences Plant cell
non-
nicotine
tobacco
Vaccine Newcastle disease in
poultry
USDA Approved in Feb.06
  Plant cell -
tobacco
Vaccines "diseases of horses,
dogs and birds"
Undisclosed
Protalix Carrot cell Glucocerebrosidase Gaucher's disease FDA approved May'12 - On Sale
  Carrot cell Acetylcholinesterase Biodefense Phase 1
  Carrot cell Alpha-galactosidase Fabry's Disease Pre-clinical
  Carrot cell Antitumor necrosis
factor
Arthritis Pre-Clinical
Guardian Biosciences Canola Edible vaccine Coccidiosis in poultry CFIA phase 2
/ Nexgen Biotech Oriental
Melon
Thyroid stimulating
hormone receptor
Diagnosis of Graves
disease
Available from company
  Oriental
Melon
Viral antigens Rapid detection of
Hantaan and Puumala
Available from company
CIGB (Cuba) Tobacco Recombinant
Monoclonal (Mab)
Purification re-agent
in Hep."B" vaccine
Approved mid 2006 in Cuba
D.Yusibov and others Spinach Vaccine Rabies Phase 1 successful in 2002
Farmacule Tobacco Virtonectin Research use Available from company mid 2007
Distribution under negotiation
NeoRx / Monsanto Maize Antibody Cancer Phase 2 ( failed)
Applied Biotech.
Institute & partner
Maize Undisclosed Undisclosed Animal trials underway
Sembiosys
(liquidated 2012)
Safflower Insulin Diabetes Phase 3
  Safflower Apolipoprotein AI Cardiovascular Phase 1 trial planned
Chlorogen & partner Tobacco a TGF-Beta protein Ovarian Cancer Advanced animal trials
Pharma-planta
consortium
Tobacco 2G12 IgG HIV prophylactic Phase 1
TransPharma srl Tobacco -Glucosidase Gaucher's disease Phase 1
Plantechno srl Tobacco -Glucosidase Gaucher's disease Pre-clinical
  Rice Apo-A1 (Milano) Cardiovascular disease Preclinical.
Patent protection in the USA
  Soya Lactoferrin Infant formula
enhancer
Preclinical.
Agragen Flax Human serum albumin Maintenance of blood
plasma pressure
Pre-clinical
Medicago
bought by MTPC, Japan
& Philip Morris Invs
2013
Tobacco Vaccine Pandemic avian flu H5

Phase 2 successful
USA/Canada Emergency Use
Authorization 2013

  Tobacco Vaccine Seasonal quadrivalent vaccine
H1N1, H3N2 & two B influenza strains
Phase 1 successful
Phase 2a advanced 2014
  Tobacco Vaccine Rabies Pre-clinical
  Tobacco Vaccine Rotavirus Pre-clinical
  Tobacco Vaccine Undisclosed Candidate Pre-clinical
Thomas Jefferson Univ
/ Polish NAS
Lettuce Hepatitis B
surface antigen
Hepatitis B Phase 1
Intrucept Biomedicine Tobacco Griffithsin Microbicides / Antivirals Pre-clinical


PMIPs - Some advanced plant made industrial protein products
Company / Institution Plant used Product / purpose Development Stage
Sembiosis Safflower Chymosin Being sold to Cheese manufacturer
Aresa (Denmark) Thale cress Landmine detection Successful field trials. Launch 2007
Univ.Wyoming Alfalfa Spider silk "Spinning fibre" - Ready to licence
Linnaeus (Canada) Canola / Rape Non-polluting engine oil
and 2-stroke engine oil
Tested and proven at Lab scale. - Ready to licence


PMIPs - Some advanced phytoremediation plants
Company / Institution Plant used Phytoremediation target / Pollutant Development Stage
Univ. California - Berkley Mustard Selenium Successful field trials
Hungarian Acad. Sciences. Poplar Cadmium Zinc Chromium Copper Awaiting field trial permission
AIST Japan Tobacco BPA, PCP and other Chlorophenols Early field trials
Peking Univ. Collage of Life Tobacco
and Algae
Heavy metals especially Mercury Awaiting field trial permission
Univ. of York (England) Tobacco TNT and RDX Explosive Early trial


PMIPs - Some advanced plant made industrial enzymes
Company / Institution Plant used Product / purpose Development Stage
Applied Biotechnology Institute Maize Peroxidase - paper bleaching Product verification trials completed -
Available to licence
  Maize Laccase - paper bleaching Product verification trials completed -
Available to licence
  Maize Cellulase - Ethanol production Product verification trials completed -
Available to licence
  Maize Embryo specific promoters 3 different types -
Available to licence
  Maize Constitutive promoter Available to licence
  Maize Scoreable/Selectable marker Available to licence
Syngenta Maize High a-amylase for non-food
non-feed Ethanol production
USDA approved - Feb 2011

Permission is granted by Brian Marshall and MolecularFarming.com, to reprint or reproduce this work for any non-profit use, provided that the original source and author's name is included in the reproduction.
Reproducing any or all of this work for profit, without written permission of the author, will be taken as breach of copyright.

Recombinant Proteins from Plants: Methods & Protocols - 2008. editors Loic Faye & Véronique Gomord - currently the best, most up to date book on Molecular Farming