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Biotech / Medical : Biotech success, 2002

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To: Miljenko Zuanic who wrote (66)5/17/2002 8:38:09 PM
From: Miljenko Zuanic  Read Replies (2) of 117
 
This is first report from ASCO.

Please, do not follow my steps.

Only very good results.

Friday May 17, 7:24 pm Eastern Time
Press Release
SOURCE: Aphton Corporation
Further Positive Interim Results From Aphton's Phase II Clinical Trial With Stomach Cancer Patients Presented At ASCO
ORLANDO, Fla.--(BUSINESS WIRE)--May 17, 2002--Aphton Corporation (Nasdaq:APHT - News) - At the annual meeting of the American Society of Oncology (ASCO) being held in Orlando, Florida, investigators are presenting highlights from several clinical trials and studies with Aphton's anti-gastrin 17 immunogen (G17DT).

A special symposium was held today by Aventis (AVE), a major pharmaceutical company and Aphton's strategic partner for treating cancers with Aphton's G17DT. Audited results from a Phase II clinical trial in the US and Europe with previously untreated patients with advanced metastatic stomach cancer treated with Aphton's anti-gastrin 17 immunogen (G17DT) were presented by the principal investigator, Jaffer Ajani, MD. Dr. Ajani, of the MD Anderson Cancer Center in Houston, Texas, is a leading authority in the US and abroad on gastrointestinal cancers. Noting that there is no approved therapy currently available and that chemotherapy is considered only palliative, Dr. Ajani presented additional audited interim results of the clinical trial with patients with metastatic stomach cancer who were treated with Aphton's G17DT and chemotherapy consisting of cisplatin and 5FU.

Of the 36 reported and audited evaluable patients (20% more patients than previously reported), 19 had a partial tumor response (tumor shrinkage by 50% or more) for an overall response rate of 53%. One patient had a complete response (no detectable residual tumor) and 18 had a partial response. These results compare favorably with the reported response rates of chemotherapy with cisplatin plus 5 FU/Leucovorin. Aphton's anti gastrin targeted therapy adds a biological dimension to the treatment of gastrointestinal cancers.

It is estimated that there are approximately 570,000 patients with gastric cancer in the US, Europe and Japan alone. The prognosis for the overwhelming majority of these patients is very poor. Patients diagnosed with metastatic disease have five-year survival rates of only about three percent. Surgery and chemotherapy are the primary treatment options currently, but have shown only very limited benefit. Aphton believes that its anti-gastrin approach has the potential to extend life without adding toxicity to the therapeutic regimen.

Aphton is conducting one Phase III and three Phase II clinical trials. Aphton's anti-gastrin targeted therapy induces antibodies in patients that bind to both gastrin 17 and gly-gastrin and remove them from circulation before they can bind to the cancer cell and initiate cell growth. (Aphton believes this is the optimum method for achieving "growth factor inhibition.") Gastrin 17 and gly-gastrin are believed to be central growth factors, or the initiating signals, for cell growth, cell proliferation and metastasis (spread) in gastric, ie. stomach, pancreatic, esophageal, colorectal and other gastrointestinal (GI) system cancers. This signaling program is accomplished by gastrin binding to the large numbers of gastrin receptors which appear, de novo, in the great majority of cases, on tumor cell surfaces throughout the gastrointestinal system. Interrupting this process by immunizing the patient with Aphton's anti-gastrin immunogen is a precisely "targeted" immunotherapy. This specificity of targeting only cancer cells occurs because gastrin is not normally secreted and gastrin receptors are not normally found on "healthy" cells in the GI system, unless they are malignant, or on the path to malignancy (except for cells involved with normal acid secretion). Recent findings have shown that inhibiting gastrin not only inhibits cell growth, proliferation and metastasis directly, but also "unblocks" a central pathway leading to cell-suicide (apoptosis). This tilts the balance, from cell growth, to cell suicide. This effect is amplified synergistically when Aphton's drug is given together with a chemotherapeutic. Gastrin also stimulates the secretion and expression of other important growth factors and receptors within and on the surfaces of the cancer cells involved in tumor growth. Hence, inhibiting gastrin inhibits all of the foregoing factors contributing to tumor growth and spread, while simultaneously opening a central pathway to cell suicide. Aphton's anti-gastrin targeted therapy adds a biological dimension to the treatment of gastrointestinal cancers.
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