GENET archive


5-Animals: HIV drug produced by GE goats in clinical tests

----------------------------- GENET-news -----------------------------

TITLE:  Progenics and Genzyme Transgenics enter into development and 
        supply agreement for HIV drug
SOURCE: Progenics/Genzyme Transgenic press release
DATE:   February 25, 2000

-------------------- archive: --------------------

Progenics and Genzyme Transgenics enter into development and supply 
agreement for HIV drug
"Develop transgenic animals to produce PRO 542 now in clinical trials"

Tarrytown, NY, and Framingham, MA, - Progenics Pharmaceuticals, Inc. 
and Genzyme Transgenics Corporation announced today that the 
companies have signed an agreement to continue the development of a 
transgenic source of supply for Progenics' PRO 542. Under the terms 
of the agreement, Genzyme Transgenics will develop transgenic goats 
that produce PRO 542 in their milk in exchange for undisclosed fees 
and milestone payments. Genzyme Transgenics will supply product from 
the transgenic animals which Progenics will use in clinical trials. 
The contract also contemplates the eventual commercial supply of PRO 
542. The expanded agreement was entered into based upon the 
successful outcome of transgenic feasibility studies conducted by 
Genzyme Transgenics.

"Our extended alliance with Progenics reinforces the role of 
transgenic production in the development and the commercialization of 
protein therapeutics," said Sandra Nusinoff Lehrman, M.D., President 
and Chief Executive Officer of Genzyme Transgenics. "This partnership 
represents our continuing commitment to apply our transgenic 
technology to the development of innovative new therapies for unmet 
medical needs."

Progenics' most advanced HIV product, PRO 542, demonstrated 
reductions in HIV levels in adults and children who continued to have 
high levels of the virus, despite the use of approved antiretroviral 
therapies. PRO 542 has been tested in two Phase I/II clinical trials.

In single dose studies in HIV-infected adults, dose-dependent 
reductions in plasma HIV-1 RNA were seen, a measure of HIV viral 
"load." In patients receiving the highest dose, statistically 
significant decreases in HIV-1 RNA were observed, and infectious 
virus in plasma was reduced to undetectable levels for prolonged 
periods following treatment.

In February 2000 at the 7th Conference on Retroviruses and 
Opportunistic Infections, Progenics reported the results of a multi- 
dose trial conducted in HIV-infected children. In the trial, all six 
children treated with weekly doses of PRO 542 showed decreases in HIV-
1 RNA ranging up to 1.5 log10. Three of six patients showed sustained 
reductions in viral loads that persisted for as long as 14 days ost-
treatment. There have been no serious drug-related adverse events 
reported in any of the trials.

"We have been encouraged by the preliminary safety and antiviral 
activity observed with PRO 542 in the recently completed Phase I/II 
trials and are pleased to continue development of a transgenic 
manufacturing process for PRO 542 with Genzyme Transgenics," said 
Ronald J. Prentki, President of Progenics. "Given the increasing 
worldwide prevalence of HIV and the potential demand which would be 
expected for PRO 542, we consider transgenics to be the most 
appropriate manufacturing approach to meet the bulk volume and cost 
of goods requirements for a commercial product."

PRO 542 is a novel fusion protein that incorporates the HIV-binding 
region of the human cell surface receptor into a human antibody 
molecule. PRO 542 is designed to neutralize HIV by binding to the HIV 
surface glycoprotein (gp120) and preventing the virus from attaching 
itself to host cells.

This mechanism of action is unique amongst antiretrovirals that are 
either approved or in late stage clinical development. PRO 542 has 
been shown in preclinical studies to potently neutralize a wide range 
of HIV strains from all geographic regions. In an animal model of HIV 
infection, PRO 542 prevented infection by virus strains isolated from 
HIV-infected individuals.

Progenics Pharmaceuticals, Inc. is a biopharmaceutical company 
focusing on the development and commercialization of products for the 
treatment and prevention of cancer and viral diseases. The Company's 
most advanced product, GMK, is a cancer vaccine in pivotal Phase III 
clinical trials for the treatment of malignant melanoma. A second 
cancer vaccine, MGV, with broad application to a variety of cancers, 
is entering Phase II trials.

GMK and MGV are being developed in collaboration with Bristol-Myers 
Squibb Company. The Company, with CYTOGEN Corporation, has formed a 
joint venture focusing on the development of cancer immunotherapies 
based on PSMA (Prostate Specific Membrane Antigen) technology. In 
addition to PRO 542, Progenics has a follow-on HIV product, PRO 367, 
which is preparing to commence Phase I/II trials. Progenics also has 
collaborations with F. Hoffmann-La Roche Ltd in the area of HIV 
fusion co-receptors, and with American Home Products focusing on 
small-molecules targeting the CD4 receptor.

Genzyme Transgenics Corporation has successfully produced over 60 
human proteins in animals milk, including monoclonal antibodies, 
immunoglobulin fusion proteins, hard-to-express and plasma proteins. 
Genzyme Transgenics is currently working with recognized leaders in 
the biotechnology and pharmaceutical industries to produce transgenic 
proteins as potential treatments for a variety of diseases, such as 
autoimmune and inflammatory disorders, cancer and HIV/AIDS.

Genzyme Transgenics applies transgenic technology to enable the 
development and production of recombinant proteins and monoclonal 
antibodies for medical uses. Primedica Corporation, Genzyme 
Transgenics' contract research organization, provides preclinical 
development and testing services to pharmaceutical, biotechnology, 
medical device and other companies.

This news release contains forward-looking statements that involve 
risks and uncertainties. The companies' actual results may differ 
materially from those anticipated in these forward-looking 
statements. Factors that may cause such differences include, but are 
not limited to, those discussed in the companies' filings with the 
Securities and Exchange Commission, including the uncertainties 
associated with product development, the risk that clinical trials 
will not commence when planned, the risks and uncertainties 
associated with dependence upon the actions of government regulatory 
agencies and the risk that products that appeared promising in early 
clinical trials do not demonstrate efficacy in larger-scale clinical 

Additional information on Progenics is available at http://
Additional information on Genzyme Transgenics Corporation is 
available at
This release is available on the Internet at http://


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