Biodrugs
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Randomized Controlled Trial Multicenter Study Clinical Trial
Human haemoglobin - Northfield.
PolyHeme is a chemically modified haemoglobin solution derived from human blood. It has been developed by Northfield Laboratories as an alternative to transfused blood for the treatment of acute blood loss (such as in trauma or surgery). Single molecules of haemoglobin are toxic to the kidneys and cause vasoconstriction. ⋯ Pending market approval of PolyHeme, the company will initially produce 75 000 units of the product, but expects this to increase to 400 000 units annually. Wall Street analysts have estimated the market potential for a substitute blood product to be in the "multibillion-dollar" range, according to the CEO. However, launch of PolyHeme was at the time said to be "a couple of years away".
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Review
INGN 201: Ad-p53, Ad5CMV-p53, Adenoviral p53, INGN 101, p53 gene therapy--Introgen, RPR/INGN 201.
Introgen's adenoviral p53 gene therapy [INGN 201, ADVEXIN] is in clinical development for the treatment of various cancers. The p53 tumour suppressor gene is deleted or mutated in many tumour cells and is one of the most frequently mutated genes in human tumours. INGN 201 has been shown to kill cancer cells directly. ⋯ In December 2002, Aventis Pharmaceuticals was issued US patent No. 6,262,032 B1 entitled "Method of Destroying Hyperproliferative Cells by Combining p53 and Taxoid Treatment". Introgen has an exclusive license to this patent and is using this type of combination therapy in its breast cancer trial. Introgen expects to realise $US 2.5-3 million from sales of INGN 201.
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Iodine-131 tositumomab [B1, Bexxar , iodine-131 anti-B1 antibody] is a murine antibody conjugated to iodine 131 that recognises and binds to the B1 (CD20) antigen which is found specifically on B lymphocytes. Iodine-131 tositumomab has a dual mechanism of action. It is capable of initiating a host immune response to those B cells to which it is attached, and it also triggers apoptosis in a significant proportion of the cells to which it binds. ⋯ These actions however, should have no effect on the regulatory process that Zevalin is completing, or prevent IDEC from launching the drug before iodine-131 tositumomab. A year earlier, in March 2001, the Financial Times reported that Bexxar could reach peak sales of $US120 million. In 1998, Coulter Pharmaceutical received a licencee fee payment of $US34 million from SmithKline Beecham (now GSK) in the fourth quarter of the year, as part of the joint development and commercialisation agreement for Bexxar.
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Adis CommentsAVAX Technologies is developing a therapeutic melanoma vaccine [M-Vax, DNP-VACC] consisting of autologous tumour cells conjugated to a highly immunogenic hapten, dinitrophenyl, which makes the cancer cells more easily recognised by the immune system. AVAX licensed the autologous cell vaccine technology (AC Vaccine) from Thomas Jefferson University in Philadelphia, USA, where it was originally developed. M-Vax was launched in Australia in the first half of 2000, but was withdrawn from this market in September 2002 due to financial constraints faced by the company and its need to focus its resources on initiatives that provide the greatest return. ⋯ In return, Ferrer will make payments to AVAX for the product as well as certain milestone payments for marketing and registration goals. M-Vax was manufactured in Australia by Bioenterprises, a subsidiary of Biotech Australia. However, in 2002, the manufacturer underwent an acquisition with significant changes, which resulted in its decision to discontinue manufacturing M-Vax.