A small munch for CEGE:
>>FOSTER CITY, Calif., Aug. 2 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today announced that it has entered into a definitive agreement for the acquisition of Calydon, Inc., a private biotechnology company located in Sunnyvale, California focused on developing therapeutic products for cancer. The acquisition, which has been unanimously approved by the boards of directors of both companies, will expand Cell Genesys' growing cancer product pipeline with a complementary group of cancer treatments based on oncolytic viruses, including CV706, which is expected to enter Phase III clinical trials for early-stage prostate cancer during 2002.
The transaction, which is subject to customary closing conditions, is expected to close in approximately 30 days and is structured as a stock-for-stock transaction in which Calydon shareholders, noteholders and management will receive approximately 935,000 shares of Cell Genesys stock valued at approximately $17.4 million based on a 30 trading day trailing closing price average ending July 31, 2001. Cell Genesys will also assume Calydon's liabilities of approximately $2.6 million. Cell Genesys plans to close Calydon's facilities in early 2002 but expects to retain the majority of Calydon's approximately 20 employees. Dr. Dan Henderson, president and chief executive officer of Calydon, will serve as a consultant to Cell Genesys during a transition period.
``We are very impressed by the clinical data already demonstrated for CV706, Calydon's lead product candidate for early stage prostate cancer and are pleased to add this product and other related products to our growing pipeline of innovative cancer treatments. Calydon's products are highly complementary to both our GVAX® cancer vaccine products and other cancer gene therapies and could, together with GVAX® prostate cancer vaccine and GVAX® lung cancer vaccine, provide us with as many as three products entering Phase III trials by the end of 2002,'' stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. ``We feel that the addition of this product platform, for which Cell Genesys will acquire full worldwide commercial rights, provides further value for our company and our shareholders and does so at a very compelling price.''
``I strongly believe that the Calydon family of cancer products could have an important role in the future of treating multiple cancers and that Cell Genesys has the financial resources and product development expertise to give Calydon's products the best possible chance for success,'' stated Dan Henderson, Ph.D., president and chief executive officer of Calydon, Inc.
CV706 for Early Stage Prostate Cancer
CV706 has demonstrated encouraging results in Phase I/II studies and is expected to enter Phase III clinical trials during 2002. CV706 targets newly diagnosed, high risk, early stage prostate cancer and is injected into the prostate in much the same way as radiation seed therapy. In contrast, Cell Genesys' GVAX® prostate cancer vaccine is currently being developed for advanced stage prostate cancer patients who have relapsed following surgery and/or radiation therapy and have also failed hormone treatment. Results from an initial Phase I/II study of CV706, which was completed in 21 patients with recurrent, organ-confined prostate cancer, demonstrated that CV706 was safe and well tolerated. The trial also demonstrated compelling evidence of antitumor activity including the stabilization of prostate-specific antigen (PSA) levels in all patients treated at the two higher dose levels (11 patients). Moreover, nine of the 11 patients demonstrated greater than 35 percent reductions in PSA levels below baseline and in four cases, there were greater than 50 percent reductions qualifying as partial responses, with an average duration of nine months. Two of the partial responses were continuing at 12 and 16-month follow-up. Cell Genesys expects to initiate this year a follow-on Phase II trial combining CV706 with radiation therapy in preparation for Phase III trials in which CV706 plus radiation therapy will be compared to radiation therapy alone for preventing clinical relapse in newly-diagnosed, intermediate to high risk prostate cancer patients.
ARCA(TM) Technology Platform
CV706 is the lead product based on Calydon's proprietary ARCA(TM) (Attenuated Replication Competent Adenovirus) technology platform which employs oncolytic (cancer cell killing) viruses engineered to selectively replicate in and kill targeted cancer cells, leaving healthy normal cells largely unharmed. The technology utilizes adenovirus, one of the commonly occurring viruses responsible for the common cold. The engineered viruses are delivered either by direct injection into tumors or by intravenous administration and are thousands of times more specific for killing cancer cells than standard chemotherapeutic drugs. Once ARCA(TM) is delivered to the cancer cells, the virus replicates within the cell until it bursts thereby destroying the cell and spreading the newly created viruses throughout the tumor repeating the cycle in the neighboring cancer cells. The virus specifically targets cancer cells and not the surrounding tissue, so after destroying the cancer cells, the engineered virus is cleared by the body's immune system.
ARCA(TM) Product Pipeline
In addition to intratumoral delivery of CV706 for early stage prostate cancer, a Phase I/II study with CV787, which is delivered intravenously, is under way in later stage prostate cancer patients. Approximately 20 patients with advanced metastatic disease are being enrolled in the multicenter study. Future studies of CV787 would likely include an evaluation of combination therapy with standard chemotherapy for prostate cancer. Beyond prostate cancer, the ARCA(TM)-based technology is demonstrating encouraging results in preclinical studies of colon cancer (CV798), bladder cancer (CV884) and liver cancer (CV890). Cell Genesys expects to manufacture CV706 and other ARCA(TM) products in its recently acquired GMP (Good Manufacturing Practices) facility located in San Diego, CA.<<
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Cheers, Tuck |
