With the new - and short - trading week opened up, here's a few updates from around the biotech world:

DNDN: After a week full of milestones for Dendreon Corporation (DNDN), shares continued to tick higher and maintained their stance above the forty dollar level as it looks as if the $350-$400 million year-end sales targets may well be within reach.

Although the positive news developments for Dendreon were catalysts for the future, the flat trading in the share price is a good indication that these events were already predicted and priced in.

That said, demand for Provenge is not shrinking, and as Dendreon makes the climb to full production capacity, we're talking about a billion-dollar-per-year treatment here. The company is also developing its pipeline and still looks like a decent long term growth prospect, in my opinion.

This company is the leader of the first wave of cancer immunotherapeutic treatments.

CYTR: Already labeled as a stock to watch after announcing positive newsearlier this month for another of its pipeline candidates, CytRx (CYTR) opened the new trading week by announcing that it had received the coveted Orphan Drug Designation for INNO-206 in the treatment of soft tissue sarcomas.

An "Orphan Drug," as defined by the FDA, is one that treats a rare disease or condition, with "rare" being defined as one that affects less than 200,000 people in the country.

The real significance behind the designation, however, is that the company sponsoring the drug, in this case CytRx, receives market exclusivity for a period of seven years, assuming compliance with certain FDA requirements is maintained.

Of CytRx's three primary pipeline candidates, INNO-206 is the earliest along in the clinical stages of development, but the newly-awarded designation looks to invigorate the development of the product. According to Tuesday's release, CytRx will conduct a quick turnaround from an ongoing Phase Ib trial - which is evaluating dosage and safety standards - into a Phase IIb trial that will test the product in the soft tissue sarcomas indication.

The Phase IIb trial is being geared up for a second half, 2011 launch.

Steven Kriegsman, CytRx President and CEO stated in the press release that, "Our strategy to move quickly into a Phase 2b trial with INNO-206 in soft tissue sarcomas is further supported by the FDA’s approval of orphan drug designation. We envision a significant opportunity in this indication due to the objective clinical responses seen with INNO-206 in patients with sarcomas in an earlier Phase 1 trial as well as preclinical data.”

To date, CytRx has seven clinical trials either under way or in the works, with bafetinib and tamibarotene already being tested in multiple Phase II trials.

The ENABLE trial is measuring bafetinib for effectiveness in high-risk B-cell chronic lymphocytic leukemia (B-CLL), while another Phase II - titled PROACT - tests the product candidate in advanced prostate cancer. A pharmacokinetic clinical trial is also being conducted for brain cancer.

Tamibarotene is being tested in a double-blind placebo-controlled Phase 2 trial in patients with non-small-cell lung cancer as well as in a registration clinical trial as a treatment for acute promyelocytic leukemia (APL).

The potential abounds for CytRx, with a full pipeline of product candidates and numerous trials underway. Should these Phase II trials materialize into successful results warranting further studies, then the CYTR share price could appreciate quickly. KERX, for instance, was barely trading for a buck when that company's pipeline was at a similar stage of development.

The full and developing pipeline offered by CytRx makes it worth taking a look, and the positive news developments over the past few weeks should have this one on some additional speculative radars.

TTNP: The rebound of Titan Pharmaceuticals (TTNP.ob) continued on Tuesday, jumping by as high as eleven cents on the day before closing just a couple of pennies to the upside on decent volume.

Titan was hammered last month when it looked as if there would be a delay in the unblinding of Probuphine results while some issues with the FDA regarding the trial's Statistical Analysis Plan (SAP) were sorted out, but a quick follow-up by Titan indicated that the initial concerns were unwarranted and the results are expected out this month.

Keep an eye on Titan, as this stock has a history of volatility leading into news and trading could get pretty exciting over the next few weeks.

In addition to Titan's trials for Probuphine in the treatment of opioid addiction, the product is also being developed for the treatment of chronic pain. The ProNeura drug delivery technology is also of value in itself, and Titan looks to have a solid future - although an unexpected setback in this latest trial would send shares lower, in my opinion.

Keep an eye on Titan. With Probuphine results pending, and with Fanapt royalty money rolling in, this company is a nice buyout candidate.

APRI: The volatile Apricus Biosciences is back to trading for under five dollars, after having jumped as high as six dollars over the past couple of months.

Apricus closed out the month of June by announcing that the European regulatory authorities have accepted the company's application for Vitaros approval, the company's topical treatment for erectile dysfunction that is already approved in Canada.

Vitaros, for which Apricus has already landed Bracco SpA as its partner is Italy, is expected to be commercially launched in Canada later this year. According to previous statements made by company officials, a Canadian partner was expected to be announced by the end of the first half, indicating that either an announcement is close - or a partnership did not materialize.

In additional news, the company recently announced that it is "reconsidering its regulatory strategy for its foot fungus treatment MycoVa, indicating it may seek approval to market the drug for patients who don't have athlete's foot."

It looks as if new analysis of the completed MycoVa trials showed that the treatment work in a small group of patients, leading to the potential new course of action for the company.

It'll be worth watching the APRI trading action over the near term.

Standard volatility aside, investors are also on the lookout for partnership news from Canada and/or an update on the Vitaros commercial launch.

Disclosure: Long TTNP.

Add a Comment