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▲SOLVAY PHARMACEUTICALS AND CV THERAPEUTICS (CVTX): Good news came for these firms as the FDA
approved an additional indication for ACEON®, the firms’ ACE inhibitor used for the control of high blood
pressure. The FDA approved the drug for patients with stable coronary artery disease to reduce the risk of
mortality or non-fatal myocardial infarction (MI). The new indication is based on the EUROPA study, which
demonstrate that the drug can provide benefit in stable coronary artery disease patients with or without
hypertension in a broad range of younger and older patients, when used in combination with current
conventional therapy.

Roles of the firms: CV Therapeutics is responsible for brand marketing activities and has established a
cardiovascular specialty sales force to promote the product. Solvay Pharmaceuticals continues to handle the
manufacturing and distribution of the product, and its primary care sales force also continues to promote the
product. Solvay Pharmaceuticals books all sales of ACEON® and CV Therapeutics will receive a share of
sales above a pre-specified baseline. There were no upfront payments by either party associated with the co-
promotion agreement.
Prohost Comments: There is no doubt that the new labeling should allow for the maximization of the potential
for ACEON®. Sales will definitely increase.
OXiGENE (OXGN): Updated clinical trial data the firm’s lead product Combretastatin A4 Prodrug (CA4P)
demonstrated that it is well tolerated in combination with Carboplatin or Paclitaxel, showing much less toxicity
than anticipated. The drug demonstrated encouraging early signs of anti-tumor activity. Next move will be a
multi-center Phase 2 study evaluating the efficacy of the triple combination therapy in platinum resistant
ovarian patients.
The firm believes that this data is compelling and provides the impetus for it to move forward aggressively towards later-stage clinical development in patients where this treatment protocol is utilized. CA4P is currently being studied in seven clinical trials in oncology, including anaplastic thyroid, lung, head and neck, prostate, colorectal, ovarian, cervical cancers and other imageable tumor types. These clinical trials involve the use of CA4P in both single-agent and combination therapies. It is also currently being studied in a Phase 2 trial in myopic macular degeneration. CA4P leads a novel class of drug candidates, which have been referred to by OXiGENE as vascular targeting agents
(VTAs). CA4P attacks the vascular structure of solid tumors and other diseases characterized by the formation of aberrant
blood vessels. The compound triggers a change in the shape of the endothelial cells lining these blood vessels, in turn
blocking the flow of blood to a tumor and depriving it of oxygen and nutrients essential to its survival. Similarly, in eye
diseases that are characterized by abnormal blood vessel growth, CA4P has been shown in preclinical studies to suppress
development and induce regression of these unnecessary blood vessels.
LORUS THERAPEUTICS was able to select two molecules, ML-133 and LT-253 for further development for
cancer treatment. ML-133 and LT-253 are part of the ML-series, which is a group of novel low molecular
weight compounds that seems to have anti-proliferative activity against many human cancer cell lines.
The NCI selected ML-133 for testing in the Hollow Fiber Assay to assess in vivo anticancer activity and
systemic availability. This makes ML-133 one of a small percentage of compounds selected by the NCI for
testing in this assay. ML-133 demonstrated antitumor efficacy towards several human cancers. LT-253,
which is related in chemical structure to ML-133, has also demonstrated potent growth inhibition in xenograft
models of various human cancers, including colon carcinoma and non-small cell lung cancer.
Good beginning.
"In chemotherapy, the selection of the right dose is one of the greatest
challenges in the treatment of cancer patients,"
▲THIRD WAVE TECHNOLOGIES (TWT) The FDA cleared its in vitro pharmacogenetic Invader® UGT1A1
Molecular Assay that identifies patients who may be at increased risk of adverse reaction to the chemotherapy
drug Camptosar (irinotecan).
The firm’s Invader molecular assay detects and identifies specific mutations in a gene that has been associated with the risk of adverse reaction to the treatment. "The selection of the right dose is one of the greatest challenges in the treatment of cancer patients,"
said Dr. Howard L. McLeod, professor of oncology at Washington University School of Medicine and a
recognized thought- leader in the field of pharmacogenetics. "The recent expansion of available therapies for
colorectal cancer has made toxicity avoidance an important aspect of the clinical decision."
Prohost Comments: This firm is one of the first to contribute to a program that will protect patients from taking
drugs that would hurt them instead of healing them. As you will see in the upcoming Prohostt publication,
personalized medicine will soon be joining the medical practice and tests, like the UGT1A1 Molecular Assay of
Third Wave Therapeutics will become a condition for prescribing a drug to patients. This is great news that
many investors might not appreciate at this moment, but will feel tomorrow.
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