https://rodman.bluematrix.com/docs/pdf/7d196603-924f-407c-9783-9084ae0d4...

REVIEW IN ONCOLOGY
During the weeks of August 14 and August 21, 2010 (from August 14, 2010 to August 28, 2010) significant news items pertaining to the oncology sector were reported including:
1. Cell Therapeutics (CTIC, Market Perform) received notice that the European Medicines Agency has validated the expanded Pediatric Investigation Plan for pixantrone for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma, with the company planning to submit the Marketing Authorization Application for pixantrone in 2H10;
2. EpiCept (EPCT, Market Outperform) received a refusal to file letter from the FDA for a New Drug Application for Ceplene, in which the FDA concluded that the application did not establish Ceplene’s therapeutic contribution in combination with IL-2, and recommended that an additional confirmatory pivotal trial using overall survival as a primary endpoint be conducted;
3. Idera Pharmaceuticals (IDRA, Market Outperform) earned a $3.8 MM milestone payment following Merck KGaA’s initiation of a Phase 1b clinical trial evaluating the TLR9 agonist IMO-2055 in combination with cisplatin, fluorouracil and Erbitux for the first-line treatment of patients with squamous cell carcinoma of the head and neck (SCCHN);
4. Enzo Biochem’s (ENZ, Market Outperform) partner GeneNews (GEN.TO, Not Rated) presented data at the Next Generation Dx Summit describing the application of ColonSentry, a blood test that assesses an individual's current risk for colorectal cancer, to 377 colorectal cancer patients and 409 controls, showing that an RNA biomarker could detect both left- and right-sided colorectal neoplasms;
5. Plexxikon (Privately Owned) published results in the New England Journal of Medicine from a Phase 1 trial evaluating PLX4032 for the treatment of metastatic melanoma in patients with the BRAF V600E mutation, demonstrating some responses in nearly all patients, with 81% of patients exhibiting tumor shrinkage of at least 30%; and
6. Genentech/Roche (RO.SW, Not Rated) received a Refuse to File letter from the FDA regarding a BLA for accelerated approval for trastuzumab-DM1 (T-DM1), an application that was based on the results of a single-arm Phase 2 study which showed that T-DM1 shrank tumors in one-third of women with advanced HER2 positive breast cancer who had received on average 7 prior therapies.
Companies mentioned in this report include:
1. ImmunoGen (IMGN, Not Rated)

2. Synta Pharmaceuticals (SNTA, Not Rated)

3. Bristol-Myers Squibb (BMY, Not Rated)

4. Advaxis (ADXS.OB, Not Rated)

5. Pfizer (PFE, Not Rated)

6. Astellas (ALPMF.PK, Not Rated)

7. Emerging Healthcare Solutions (EHSI.PK, Not Rated)

8. Radient Pharmaceuticals (RPC, Not Rated)

9. Chronix Biomedical (Privately Owned)

10. TOPEX (Privately Owned)

11. LFB Biotechnologies (Privately Owned)

12. BioScale (Privately Owned)

And many more…

REVIEW IN STEM CELLS
During the weeks of August 14 and August 21, 2010 (from August 14, 2010 to August 28, 2010) several significant news items pertaining to the stem cell sector were reported including:
1. StemCells (STEM, Not Rated) published new preclinical data demonstrating that the company's proprietary human neural stem cells restore lost motor function in mice with spinal cord injury, when administered at time points beyond the acute phase of trauma, suggesting the potential to treat a much broader population of injured patients than previously demonstrated; and
2. Neuralstem (CUR, Not Rated) filed an Investigational New Drug application with FDA to initiate a Phase 1 safety clinical trial evaluating the company’s spinal cord stem cells for the treatment of spinal cord injury, aiming to enroll a total of 16 long-term, or chronic, spinal cord injury patients exhibiting an American Spinal Injury Association (ASIA) Grade A level of impairment one-to-two years post-injury.

ONCOLOGY AND STEM CELL JOURNAL REVIEW
We have searched recent journal articles and highlighted those that warrant investor attention.
ONCOLOGY AND STEM CELL CONFERENCES
We have compiled a conference calendar from September 2010 to December 2010. Data presented at these conferences may affect select companies within the biotech/pharma sector.