Company (Location) |
Product |
Description |
Indication |
Status (Date)# |
Algeta ASA (Oslo, Norway) |
Alpharadin |
Radium-223 chloride |
Endocrine-refractory breast cancer |
Phase II data showed that it met its co-primary endpoings by significantly reducing the levels of bone alkaline phosphatase and urine N-telopeptide during the 16-week treatment period (12/12) |
Enzon Pharmaceuticals Inc. (Piscataway, N.J.) |
PEG-SN38 |
EZN-2208; pegylated version of SN38 |
Metastatic breast cancer |
Phase II data showed it demonstrated activity with an overall response of 21% in those treated with anthracycline and taxane and 11% in those treated with anthracycline, taxane and capecitabine (12/12) |
Exelixis Inc. (South San Francisco) |
Cabozantinib |
An inhibitor of MET, RET and VEGFR2 |
Metastatic breast cancer |
Preliminary data from 45 patients with previously treated disease showed that 14% had a partial response, 59% had stable disease and 20% had progressive disease in the Phase II trial (12/9) |
Galena Biopharma Inc. (Lake Oswego, Ore.) |
NeuVax |
E75 plus GM-CSF |
Breast cancer |
Phase II trial testing NeuVax and Herceptin showed that no patients experienced recurrence, with a median follow-up of 48 months (12/12) |
Genentech Inc. (South San Francisco) |
Pertuzumab |
An HER2-targeted medicine designed to specifrically target a different region on the HER2 receptor than Herceptin |
HER2-positive metastatic breast cancer |
Phase III data suggested the drug, in combination with Herceptin and docetaxel chemotherapy, provided a 38% improvement in progression-free survival compared to Herceptin and docetaxel alone (12/9) |
Generex Biotechnology Corp. (Worcester, Mass.) |
AE37 |
li-Key hybrid-based HER2/neu peptide vaccine |
HER2-expressing breast cancer |
Phase II data suggested that disease-free survival in low HER2 expressing patients receiving AE37 plus granulocyte-macrophage colony-stimulating factor was 88.6% compared to 71.9% in the GM-CSF alone control arm (12/9) |
Genta Inc. (Berkeley Heights, N.J.) |
Tesetaxel |
Oral taxane |
Advanced breast cancer |
Phase IIb data showed that out of 24 evaluable patients, the objective response rate was 50%, including 1 complete and 11 partial responses (12/9) |
MediGene AG (Martinsried, Germany) |
EndoTAG-1 |
Monotherapy |
Triple-negative breast cancer |
Median overall survival data from its Phase II trial showed a time of 13 months in the EndoTAG-1/paclitaxel combination therapy arm, 11.9 months in the EndoTAG-1 monotherapy arm and 10.1 months in the paclitaxel monotherapy arm (12/12) |
Novartis AG (Basel, Switzerland) |
Afinitor |
Everolimus tablets |
Advanced breast cancer |
Phase III data showed the treatment more than doubled progression-free survival to 7.4 months, compared to 3.2 months with hormonal therapy alone (12/9) |
Puma Biotechnology Inc. (Los Angeles) |
PB272 |
Neratinib |
Metastatic or locally advanced breast cancer |
Phase I/II data showed that PB272 when given in combination with capecitabine, was found to be tolerable, while efficacy data showed that 52% of patients not previously treated with Tykerb experienced a partial response and 8% experienced stable disease (12/12) |
Syndax Pharmaceuticals Inc. (Waltham, Mass.) |
Exemestane |
A hormonal therapy |
Locally recurrent or metastatic estrogen receptor-positive breast cancer |
Phase II data of exemestane with its HDAC inhibitor entinostat in 130 patients showed median overall survival of 26.9 months compared to 19.8 months for exemestane plus placebo (12/9) |
Synta Pharmaceuticals Corp. (Lexington, Mass.) |
Ganetespib |
Second-generation Hsp90 inhibitor |
Metastatic breast cancer |
Demonstrated clinical activity as monotherapy in heavily pretreated patients (12/9) |
Notes: Public biotech company stock symbols can be found in the stock report located on the last two pages of this issue. # The date indicated refers to the BioWorld Today issue in which the news item can be found. |