Company Press Release
Techniclone Clarifies Oncolym Status
TUSTIN, Calif.--(BUSINESS WIRE)--March 20,
2000--Techniclone Corporation (NASDAQ: TCLN - news) issues a clarification to an article released by Bloomberg News Service on March 17, 2000. Bloomberg's article titled ``Techniclone Warns of Setback in Trials of Lead Drug Candidate'' contains information that the Company wants to clarify for its shareholders.
The Bloomberg article references the Company's 10-Q filed on March 15, 2000 in which the Company elaborates on development plans for the Company's Oncolym® anticancer drug. The Oncolym® development plans of marketing partner Schering, A.G. were originally released in a December 3, 1999
press release. In the December 3, 1999 press release, the Company announced Schering A.G. planned to ``initiate a new clinical study using a single dose protocol '' for Techniclone's Non-Hodgkin's B-cell lymphoma treatment. The single dose protocol will be used as a result of a thorough analysis of
Oncolym® and the Non-Hodgkin's B-cell lymphoma competitive marketplace. Oncolym® has been used to treat over 120 advanced, refractory non-Hodgkin's b-cell lymphoma patients in four prior human studies. The Company believes that a single higher dose of Oncolym® may more competitive in the marketplace.
According to Dr. John Bonfiglio, Techniclone's Interim President, ``the original trials of the drug called for patients to receive three injections, a process that proved to be too cumbersome and expensive.
The cumbersome protocol also made it difficult to recruit patients into the clinical study, thus slowing its progress. In addition, analysis of the clinical data showed that approximately 80% of the patients treated with a therapeutic dose of Oncolym® responded well to the first dose. This leads us to believe a one dose protocol may be a very effective means of using Oncolym®.''
Techniclone has completed significant improvements in the manufacturing and in conjunction with the Paul Scherer Institute has also made improvements in the radiolabeling process of Oncolym®.
Techniclone has improved the antibody manufacturing yield to at least 10-fold of what it was before.
This will substantially lower the manufacturing cost of the antibody, allowing it to be more competitive in the marketplace. Techniclone has also improved the process by which the radioactive isotope is attached to the antibody. This improvement has improved the yield and the stability of the radiolabeled product leading to a product, which can more easily be transported to the clinical site and eventually to the commercial site. ``Since a new protocol was going to be used, requiring additional clinical studies, we felt it was the perfect time to implement the new manufacturing processes for the monoclonal antibody and radiolabeling,'' stated Dr. Bonfiglio. If the new processes were implemented later in the clinical trial process, the Company would have been required to do additional studies that could have adversely affected the timelines for submission to the FDA for the drug.
Using a single dose protocol may permit the delivery of a higher dose of radiation versus the multi-dose protocol. The maximum tolerated dose (MTD) of the new single dose protocol will be determined through an 18 patient dose escalation study in which efficacy will also be examined. Once the MTD
has been discovered, 28 patients will treated at the MTD to measure efficacy as part of a Phase II/III study. Subsequent to the treatment of the 28 patients, approximately 112 patients will be treated as part of the Phase III trial to provide rigorous, statistically significant proof of the drug's efficacy. It should be noted that these patient numbers are approximate and are subject to change at the discretion of Techniclone's partner Schering AG.
Techniclone feels the changes in the protocol and the improvements made in the manufacture of Oncolym® may significantly improve the commercial potential of Oncolym®. Techniclone believes its Oncolym® product can be highly competitive with products in development or already approved since
Oncolym® targets a completely different antigen (cell marker) than any other antibodies under development. This antigen, HLA-dr, is highly specific for B-cell lymphoma and unlike the other compounds in development, it has a low affinity for normal b-cells.
According to Dr. John Bonfiglio, ``Techniclone is much than a one product company. We have developed a whole new field of cancer research called collateral targeting. These technologies therapeutically target cell structures and cell types, rather than surface cancer cells, as a means to
attack solid tumors, without causing damage to surrounding healthy tissue.'' Techniclone's most advanced collateral targeting drug is CotaraTM. Cotara(tm) is currently in a multi-center Phase II clinical study for the treatment of newly diagnosed and recurrent brain cancer patients. As stated in the Company's recent 10-Q, the Company intends to initiate several additional Cotara(tm) human clinical studies on different cancers. Cotara(tm) is a trade name for the Company's platform technology,
Tumor Necrosis Therapy (TNT), which delivers radioactive isotopes directly to solid tumors. TNT is based on the principle that all solid tumors build poor vascular networks and eventually outgrow their blood supply leading to the development of a core of dead and dying tumor cells (necrotic tissue). The existence of necrotic tissue is common to all tumor types, giving TNT the capability to target a wide variety of solid tumors. TNT is capable of delivering a wide variety of therapeutic compounds directly to the tumor site while not affecting normal tissues. The Company believes there is great benefit to targeted delivery of toxic compounds directly to the tumor site. The Company's believes there is great promise in the use of TNT as a universal solid tumor cancer treatment. The Company bases this belief
on the fact that its researchers routinely cured mice with various large human carcinomas. Subsequent human clinical studies have shown significant anti-tumor activity in a variety of human solid tumors.
The Company's long term plans are to continue to test Cotara(tm) on various tumor types.
In addition to TNT, the Company has two additional collateral targeting based platform technologies that are capable of treating most, if not all, solid tumor types. Recently, the Company has received numerous patents solidifying its leadership in the field of vascular targeting. The Company's Vascular Targeting Agent (VTA) platform technology works by selectively targeting various compounds to tumor blood vessels. Once attached to the tumor vessel, these compounds cause blood clots to form.
The resultant blood clots choke off the blood supply to the tumor causing an avalanche of cell death.
The VTAs have shown remarkable anti-tumor effects in animals evidenced by complete tumor remissions. The preclincal results of the VTA platform have been widely published, including an article in Science. The Company has recently launched an aggressive non-exclusive licensing program for the
VTA technology and has signed letters of intent with SuperGen and OxiGene.
The Company also has a platform technology named Vasopermeation Enhancement Agents (VEA).
VEAs act by delivering vasoactive compounds (drugs that cause tissues to dilate) selectively to the tumor site. Once at the tumor site, these compounds cause an increase in the blood supply at the tumor
site allowing a greater uptake of a therapeutic compound. Preclinical studies have shown VEAs can increase the uptake of drugs at the tumor site by 400%. VEAs are designed to work as a pretreatment for existing chemotherapy compounds currently on the market.
TECHNICLONE Corporation is a biopharmaceutical company focused on the development, commercialization and licensing of unique technologies for the treatment of cancer, primarily based on its ``collateral targeting technologies.'' These technologies therapeutically target cell structures and cell types, rather than surface cancer cells, as a means to attack solid tumors, without causing damage to surrounding healthy tissue. The Company has three collateral technologies: Cotara(tm), Vasopermeation Enhancement Agents (VEA), and Vascular Targeting Agents (VTA). The Company
also has a direct tumor targeting agent called Oncolym® for the treatment of advanced non-Hodgkin's B-cell Lymphoma. Oncolym® has been licensed to Schering AG, Germany, which is now responsible for all existing and future Oncolym® clinical trial programs as well as marketing.
Safe Harbor Statement: This release may contain certain forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ from the Company's expectations as a result of risk factors discussed in Techniclone's reports on file with the U.S. Securities and Exchange Commission, including, but not limited to, the Company's report on Form 10K for the year ended April 30, 1999 and Form 10Q for the
quarter ended January 31, 2000.