HORSHOLM, Denmark, Nov. 20, 2003 (PRIMEZONE) -- Pharmexa -- Summary: The preliminary data from a phase I trial with the HER-2 Protein AutoVac(TM) vaccine in 10 breast cancer patients in the US indicate that the vaccine is safe and induces antibodies. Pharmexa continues the planning of the further development of the vaccine. Final data from the trial is expected in the beginning of 2004. The company expects to seek additional financing from existing shareholders and new investors through a new share issue in Q1 2004.Promising preliminary data from the HER-2 Protein AutoVac(TM) trial in the USA Pharmexa has now received preliminary antibody results from the patients in the clinical phase I trial with the HER-2 Protein AutoVac(TM) vaccine that is currently conducted in the US. The results, which are based on analysis following 3 of a total of 4 scheduled immunizations of 10 patients shows immune responses in 5 of the patients. So far, no vaccine related serious adverse events have been reported.
Pharmexa expects when the final data is available early 2004 to continue the clinical development of the HER-2 Protein AutoVac(TM) vaccine with planned additional clinical trials in the US or Europe in mid-2004.
Soeren Mouritsen, Chief Executive Officer said: "These results -- together with the data we announced previously this week regarding TNF-alpha AutoVac(TM) -- emphasize the fact that the Protein AutoVac(TM) technology works in man. This is the most important milestone in Pharmexa's history and significantly increases the likelihood of success of the products in our pipeline. The preliminary results from the HER-2 Protein AutoVac(TM) vaccine furthermore indicate that the treatment is safe. We are now awaiting the final data from the phase I trial in the beginning of 2004. The results from the phase I trial with HER-2 Protein AutoVac(TM) will also be used in the planning of Pharmexa's other development projects. We are planning the next clinical trial with TNF-alpha AutoVac(TM) in the beginning of 2005, preferably in collaboration with a partner. In addition, we expect that H. Lundbeck initiates the first clinical trials with the Alzheimer AutoVac(TM) vaccine in 2005."
About the HER-2 Protein AutoVac(TM) trial In April 2003 Pharmexa received approval from the FDA to conduct a clinical Phase I trial with the company's HER-2 Protein AutoVac(TM) vaccine at two US breast cancer centres in Cleveland and Pittsburgh.
Pharmexa's clinical Phase I trial includes 10 patients with breast cancer. The primary objective of the trial is to evaluate the safety of the HER-2 Protein AutoVac(TM) vaccine and in addition, to evaluate the ability of the vaccine to generate an immune response specifically directed against cancer cells over-expressing the oncogenic protein, HER-2.
Each patient in the trial receives a total of four injections (immunizations) with the HER-2 Protein AutoVac(TM) vaccine over a course of 10 weeks. During these 10 weeks and a subsequent 6-week period the patients are monitored for potential adverse reactions. The Investigator (the physician at the breast cancer centres responsible for the conduct of the trial) regularly examines the patients. In addition, blood samples are taken from each patient every second week for all 16 weeks to determine the patient's development of a HER-2 specific immune response (i.e. the desired effect).
The above-mentioned preliminary Phase I data are based on clinical observations and antibody results from all 10 patients following 8 weeks of trial participation and include the first 3 scheduled immunisations.
Status on Pharmexa's research and development activities
The risk in Pharmexa's pipeline is decreasing In its development of a therapeutic pipeline, Pharmexa has put in place a strategy of focusing on highly validated targets. Pharmexa's most advanced programmes are targeting HER-2 (breast cancer) and TNF-alpha (rheumatoid arthritis) following the same therapeutic rationales supported by extensive use of current immunotherapy in the market, currently worth DKK 4.8 billion (breast cancer) and DKK 13.5 billion (rheumatoid arthritis) respectively. Pharmexa is therefore working with the two most validated disease targets within human immunotherapy.
Because Pharmexa has selected validated targets, the most significant risk in Pharmexa's advanced products has been whether the AutoVac(TM) technology works in the same way in humans as in the numerous animal experiments in many different disease models that Pharmexa and its collaboration partners have conducted throughout the years. With the new data from the TNF-alpha and HER-2 projects this risk - as well as the risk related to the other projects in the pipeline - has now been significantly reduced. For Pharmexa the forthcoming challenge is now to optimise doses and formulation of the individual products.
Name Target Indication Marketing rights Status
In-house research and development programmes
PX HER-2 DNA Breast cancer Pharmexa Phase II 1
103.1
PX HER-2 MVA Breast cancer Pharmexa/BN2 Preclinical
103.2 development
PX HER-2 Protein Breast cancer Pharmexa3 Phase I
104.1
PX 101 TNF-alpha Rheumatoid Pharmexa Pre-clinical
arthritis development
PX 107 RANKL Bone disorder Pharmexa Research
Partnered research programmes
PX 106 Undisclosed Alzheimer's H. Lundbeck Pre-clinical
disease development
Undisclosed Animal Health Schering-Plough Research
Note: 1) Phase II has been approved but not initiated
2) Bavarian Nordic
3) GSK has an option on this programme, if Pharmexa decides
to out license after phase I
HER-2 AutoVac(TM) products for breast cancer
Pharmexa's most advanced product is the HER-2 DNA AutoVac(TM) vaccinefor the treatment of breast cancer. In December 2002, Pharmexaannounced the successful completion of the phase I/II clinical trialsinvolving 27 patients. Pharmexa has received approvals for a phase IIclinical trial in Denmark and the United Kingdom. However, the HER-2DNA AutoVac(TM) phase II trial was postponed for priority reasons.Furthermore, in October 2003 Pharmexa and Bavarian Nordic enteredinto a collaborative agreement that will evaluate the use of BavarianNordic's proprietary MVA-BN vector technology in combination withPharmexa's HER-2 DNA AutoVac(TM) vaccine. The parties expect thatphase l/ll clinical trials could begin in Germany and Italy within 18months.
Pharmexa is also developing a HER-2 Protein AutoVac(TM) vaccine for the treatment of metastatic breast cancer in parallel to its DNA product. Pharmexa's ongoing clinical phase I trial include 10 patients with breast cancer. The primary objective of the trial is to evaluate the safety of the HER-2 Protein AutoVacTM vaccine as well as evaluating the ability of the vaccine to generate an immune response specifically directed against cancer cells over-expressing the HER-2 receptor.
Pharmexa believes it will be advantageous to pursue clinical development of both HER-2 products contemporarily since they are designed to induce different, but potentially complementary anti-tumour effects in man. Both the HER-2 AutoVac(TM) products may have important competitive advantages over Herceptin in terms of efficacy, patient convenience and manufacturing costs. Herceptin is Roche and Genentech's monoclonal antibody breast cancer therapy launched in the US in 1998 with global sales of DKK 4.8 billion in 2002.
TNF-alpha AutoVac(TM) product for chronic inflammation Pharmexa is developing an anti-TNF-alpha product for treatment of rheumatoid arthritis but the product may also be applicable to other chronic inflammatory diseases such as psoriasis and Crohn's disease. This product is another example of Pharmexa's strategy to apply its technology on developing a competitive product based on already validated targets. Remicade and Enbrel, both anti-TNF-alpha based drugs, reached total sales in 2002 of DKK 13.5 billion. The anti-TNF-alpha AutoVac(TM) vaccine for treatment of rheumatoid arthritis is currently being optimised in pre-clinical studies and Pharmexa expects to submit an IND to the FDA on this product in early 2005, if the financial resources of the Company or the possible out licensing of the product so permit.
On Monday November 17, 2003 Pharmexa announced that an earlier TNF-alpha AutoVac(TM) vaccine induced antibodies in approximately half of the patients in a phase I/II trial conducted in London in 2000-2001 in 28 cancer cachexia patients. As in the above-mentioned case with the data from HER-2 Protein AutoVac(TM), these results show, as expected, that the AutoVac(TM) technology can induce antibodies against disease associated proteins in man.
The Alzheimer's collaboration with H. Lundbeck In April 2000 Pharmexa entered a 3-year research and license agreement with H. Lundbeck. The agreement covers the use of the AutoVac(TM) technology on a certain protein target in the central nervous system with the aim to develop a treatment of Alzheimer's disease. If successful, Pharmexa will receive milestone payments amounting to approximately DKK 150 million as well as royalties from future product sales. In December 2002 the research collaboration achieved preclinical "proof of concept" and H. Lundbeck has decided to take the project into the early development phase.
In September 2003, H. Lundbeck and Pharmexa agreed that additional research activities will be carried out by Pharmexa in collaboration with H. Lundbeck for a period of up to 24 months following completion of the original planned research programme. Furthermore, Pharmexa supports H. Lundbeck in the development of the Alzheimer vaccine.
RANKL AutoVac(TM) product for bone disorder Another example of the versatility of the AutoVac(TM) technology is the RANKL programme for the treatment of osteoporosis and other diseases characterised by bone degradation. RANKL is widely recognised as a promising therapeutic target for treatments for diseases characterized by increased bone degradation. Pre-clinical research has shown Pharmexa's anti-RANKL product to be efficacious in animal models of osteoporosis and rheumatoid arthritis. Pharmexa expects that IND filing to the FDA in the RANKL AutoVac(TM) programme could take place in 2005 provided that the necessary funding is in place.
Pharmexa's financial situation
The company expects to seek additional financing from existing shareholders and new investors through a new share issue in Q1 2004. The Swedish venture fund HealthCap has indicated their willingness to participate in a new share issue.
Nonetheless, Pharmexa maintains its assessment of the Company's financial situation. By the end of October 2003 Pharmexa had cash and cash equivalents, and marketable securities of approximately DKK 60 million. Following the refocusing and cost reductions implemented in the first half-year and taking into consideration expected revenue under existing collaborations, the company expects to be able to finance its activities until the end of the second quarter of 2004. A new out-licensing agreement in the first 6 months of 2004 is expected to extend this period.
About Pharmexa A/S
Pharmexa A/S (CSE:PHARMX) is a leading company in the field of active immunotherapy for the treatment of serious chronic diseases. Pharmexa's proprietary AutoVaca technology platform is broadly applicable, but the company has focused its resources on a number of cancer forms and chronic inflammatory diseases, with research and development programs targeted towards breast cancer, rheumatoid arthritis and bone degeneration. Collaborative agreements include Schering-Plough, H. Lundbeck and Bavarian Nordic.
For more information please visit www.pharmexa.com
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