Extreme FDA Trades: Another 18 Stocks Under 5 Bucks

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Includes: ACAD, AGEN, ALBO, ALXA, ARNA, ARUXF, ARYX, AVNR, CHTP, CLSN, CYTR, GNVC, GSK, JAV, OREX, OSTE, PSDV, TDLP, VVUS
by: Mike Havrilla

Below are extreme trades among companies with stock prices under $5 from the BioMedReports.com FDA Calendar, which includes 232 entries as of 7/3/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in Extreme FDA and Clinical Trial Calendar Trades, which are highlighted in periodic articles at BioMedReports. Another approach is to buy a basket of stocks well ahead of their expected binary events before the trading crowd arrives and causes an increase in the share price and trading volume. As with previous installments, this article is neither an endorsement of the companies profiled nor a complete list of extreme trades included in the FDA Calendar at BioMedReports.
Javelin Pharma (AMEX:JAV) ($1.22): Ereska is a non-opiate pain drug being developed by JAV for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury). A NDA filing for Ereska is possible by late 2009. On 6/23/09, JAV reported that it successfully completed a safety study of Dyloject in the U.S. and plans to submit a NDA for FDA approval in the fall of 2009.
On 3/9/09, Acrux [ASX:ACR] (OTCPK:ARUXF) ($1.03) announced that its Testosterone MD-Lotion development program achieves key milestone and will be commercialized as Axiron. Achieved enrollment of 150 men in a pivotal Phase 3 open-label trial as planned with trial results expected 3Q09 and a FDA submission anticipated by the Compnay during December 2009.
In late March, Arena Pharma (NASDAQ:ARNA) ($4.85) announced top-line results from its BLOOM clinical trial of experimental weight loss drug lorcaserin, and the Company expects to report results from the second pivotal trial, BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management), by the end of September 2009 and expects to submit a NDA for FDA approval by year-end. Vivus (NASDAQ:VVUS) ($5.90) and Orexigen Therapeutics (NASDAQ:OREX) ($5.67) also expect to report pivotal Phase 3 clinical trial results during 3Q09 for their experimental weight loss drugs Qnexa and Contrave, respectively.
On 5/6/09, Cardium (AMEX: CXM) ($1.85) announced the completion of recruitment for the Phase 2b MATRIX clinical trial to evaluate the safety and efficacy of Excellarate for the treatment of non-healing diabetic foot ulcers. The MATRIX Data and Safety Monitoring Board has reviewed safety data collected from study participants as of 4/21/09 and reported that Excellarate appears to be both safe and well tolerated, with no serious adverse events attributable to the study product. The Company expects to report on key efficacy data in September 2009, including the percentage of patients achieving complete wound closure, the rate of wound closure and the reduction of wound size at various time points.
Cardium also continues to build and enhance its InnerCool Therapies operating unit with a specific focus on the development of a new class of targeted organ-specific cooling applications, including its UroCool pelvic cooling catheter system, which is designed to induce localized cooling during surgery for prostate cancer. An application for FDA 510(k) clearance of the UroCool pelvic cooling catheter system was submitted during 1Q09.
On 5/7/09, Biodel (NASDAQ:BIOD) ($4.69) updated its plans to submit a new drug application (NDA) to the FDA during 2H09 for approval to market VIAject for the treatment of diabetes. The NDA will be based upon results from multiple pharmacokinetic and pharmacodynamic studies, studies of VIAject in patients with Type 1 and Type 2 diabetes on post-prandial glycemic control compared to regular human insulin and the rapid-acting analog, Humalog, as well as the two completed Phase 3 studies of VIAject in patients with Type 1 and Type 2 diabetes. Biodel is now preparing its NDA submission and initiating studies designed to further differentiate the therapeutic potential of VIAject from existing rapid-acting prandial insulins.
On 5/7/09, Avanir Pharma (NASDAQ:AVNR) ($2.15) provided an update on its lead, Phase 3 compound called Zenvia (dextromethorphan + quinidine). AVNR completed target enrollment on 3/16/09 of patients into the STAR trial, which is a confirmatory Phase 3 clinical trial of Zenvia in patients exhibiting signs and symptoms of pseudobulbar affect. The randomized, multi-center, international STAR trial is designed to compare the effects of Zenvia 30/10 mg, Zenvia 20/10 mg and placebo on the rates of involuntary crying and laughing episodes. The final number of patients exceeded the original target by approximately 20% allowing a larger safety database and increased statistical power for the study. AVNR affirmed guidance that top-line data from the confirmatory Phase 3 STAR trial is expected no later than September 2009.
On 5/7/09, Alexza Pharma (NASDAQ:ALXA) ($2.36) announced update on AZ-004 (Staccato loxapine) NDA timeline as the Company continues its scale-up of commercial manufacturing and quality systems processes. ALXA expects an AZ-004 NDA submission to the FDA during the first quarter of 2010 (1Q10). Alexza is developing AZ-004 for the acute treatment of agitation in patients with schizophrenia or bipolar disorder.
On 5/11/09, Acadia Pharma (NASDAQ:ACAD) ($2.01) provided the following update along with its quarterly financial results: Enrollment was completed in the Company’s first pivotal Phase 3 trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP) in early May 2009. Top-line results from this trial are expected to be reported by the end of 3Q09.
On 5/12/09, Celsion (NASDAQ:CLSN) ($4.47) provided an update on the status of its lead oncology compound in clinical development, ThermoDox, which is a proprietary heat-activated liposomal encapsulation of doxorubicin. ThermoDox is currently being evaluated under a Special Protocol Assessment with the FDA in a 600 patient, global Phase 3 trial in patients with non-resectable primary liver cancer. Enrollment in the global Phase 3 primary liver cancer study includes 33 clinical sites activated to date with plans to increase the number of sites to 65 by the end of 2009. CLSN expects to substantially complete patient enrollment in this trial within the first quarter of 2010 (1Q10). CLSN is also conducting a pivotal Phase I/II recurrent chest wall breast cancer clinical trial for ThermoDox and is enrolling patients at four clinical sites with expected completion of patient enrollment for this study in the second quarter of 2010 (2Q10).
On 6/1/09, GenVec (NASDAQ:GNVC) ($0.72) announced that overall survival data in locally advanced pancreatic cancer patients treated with TNFerade in GenVec's ongoing Phase 3 Pancreatic Cancer Clinical Trial with TNFerade (PACT) were presented at ASCO. The analysis concluded that TNFerade appeared to be safe and well-tolerated, indicating a 25% reduction in the risk of death in the TNFerade plus standard-of-care (SOC) arm compared to the patients receiving SOC alone. In the SOC patients, 75% of the patients died within approximately 11.8 months. However, in the TNFerade plus SOC group, 75% of the patients did not die until approximately 19.4 months. GenVec's PACT trial is a multi-center, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in patients with locally advanced pancreatic cancer. The next interim analysis is expected to occur after two-thirds of the events (or 184 deaths) have occurred in the trial. Results are expected to be announced in early 2010.
On 6/1/09, Antigenics (NASDAQ:AGEN) ($1.93) announced results of an interim analysis from the Company’s ongoing global patient survival registry, which showed that patients with kidney cancer at intermediate risk of disease recurrence demonstrated an approximately 46% lower risk of death when treated with Oncophage (vitespen) cancer vaccine compared with observation (n = 362; P = 0.036; hazard ratio [HR] = 0.54). The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study. Final results from INSPIRE are expected mid-2010. In October 2008, AGEN submitted a marketing authorization application to the European Medicines Agency (EMEA) requesting conditional approval for Oncophage in earlier-stage, localized renal cell carcinoma. AGEN expects a decision on its European marketing application by late 2009 and the Company has not filed for U.S. marketing approval of the drug as of yet.
On 6/10/09, Osteotech (NASDAQ:OSTE) ($4.28) announced that it has completed enrollment for the clinical trial of its DuraTech BioRegeneration Matrix. Based upon Osteotech's proprietary HCT (human collagen technology) platform, DuraTech is used to repair dura mater (the tough, outermost membrane surrounding the brain and spinal cord) during cranial surgical procedures. DuraTech is the first of several products that Osteotech is developing based upon its first-in-class HCT platform. A total of 60 patients were enrolled in the clinical study and the trial will evaluate the patients at 30 and 90 days post-operatively to assess the safety of DuraTech compared to historical surgical procedure outcomes. Osteotech plans to utilize the results stemming from this trial to support its 510(k) filing for marketing clearance with the FDA during 3Q09 with expected marketing clearance before year-end.
On 6/15/09, pSivida (NASDAQ:PSDV) ($1.77) announced that two newly-published peer reviewed scientific papers showed that Fluocinolone acetonide (FA) both inhibited VEGF (vascular endothelial growth factor) production and protected retinal cells and function (a neuroprotective effect). These findings support expanding the treatment indications for the Company’s lead product, Iluvien, a miniaturized, injectable, sustained-release drug delivery system that releases FA directly into the eye. Iluvien is being evaluated in Phase 3 clinical trials for the treatment of Diabetic Macular Edema. Initial data from the 950-patient trials are expected to be reported by the end of 2009, with a NDA filing scheduled for early 2010. PSDV stated that the newly-published results support expanding the use of Iluvien beyond DME to include conditions such as wet and dry AMD (age-related macular degeneration) for which Phase 2 trials are currently underway; and other degenerative conditions such as retinitis pigmentosa.
On 6/15/09, Transdel Pharma (OTC:TDLP) ($1.40) announced that the Company anticipates reporting top-line results from their current Phase 3 study of Ketotransdel during 3Q09. The Phase 3 study consists of a randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of Ketotransdel, a topical cream based non-steroidal anti-inflammatory drug (NSAID), in acute soft tissue injuries of the upper and lower extremities. The multi-center trial is being conducted at approximately 30 sites in the U.S. and will enroll about 350 patients. TDLP plans to initially seek FDA approval of Ketotransdel for the treatment of acute pain and then expand the label to include additional indications such as osteoarthritis.
On 6/16/09, ARYx Therapeutics (NASDAQ:ARYX) ($4.52) announced that the database for the EmbraceAC study has been locked and the study remains on schedule, with the efficacy and safety results to be available during the week of 7/6/09. The study was designed to compare its oral anticoagulation therapy, tecarfarin (previously ATI-5923), against the leading anticoagulant agent, warfarin. Based upon recent interactions with the FDA, ARYX believes this trial could be positioned as one of the required registration studies for tecarfarin.
Tecarfarin is modeled on the drug warfarin as an oral blood thinner, which works in the same way (as a selective inhibitor of VKOR or the vitamin K epoxide reductase enzyme). Unlike warfarin, which is dependent upon cytochrome P450 enzymes for metabolism, tecarfarin was designed to avoid drug-drug interactions through its alternative metabolic pathway. ARYX believes this alternate metabolic pathway for tecarfarin may result in more predictable dosing and anti-coagulant response compared to warfarin.
On 6/30/09, Chelsea Therapeutics (NASDAQ:CHTP) ($4.24) reached its target enrollment of 82 patients for Study 302, the first of two pivotal Phase 3 clinical trials in the Company’s registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). CHTP expects to report the top-line results from this trial and complete enrollment in a second ongoing Phase 3 trial during 3Q09. The Company also plans to submit a U.S. marketing application to the FDA during 4Q09.
On 6/30/09, CytRx Corp. (NASDAQ:CYTR) ($1.19) announced that it filed a report (including results from an animal toxicology study) with the FDA in response to the Agency’s partial clinical hold on the Company’s Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). CYTR expects that the FDA will review the report during 3Q09 and stated that the Agency’s partial clinical hold was unrelated to data generated by human studies and arimoclomol has been studied in seven Phase 1 and two Phase 2 clinical trials without any significant adverse events.
On 6/11/09, Human Genome Sciences (NASDAQ:HGSI) ($2.88) announced Phase 2 continuation data which demonstrated sustained improvement in disease activity and patient response rate through four years of BENLYSTA therapy in combination with standard of care in patients with serologically active systemic lupus erythematosus (SLE). The frequency of disease flares as measured by the SELENA SLEDAI flare index and by BILAG A or B organ domain scores decreased over four years of BENLYSTA therapy and there was no increase in overall adverse events, serious adverse events, malignancies or serious infections over time.
HGSI and GlaxoSmithKline (NYSE:GSK) have selected BENLYSTA as the brand name for belimumab (formerly known as LymphoStat-B). HGS and GSK expect to report the first Phase 3 data for BENLYSTA in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients. On 7/1/09, HGSI announced that it expects to have top-line results available on 7/20/09 for BLISS-52, the first of two pivotal Phase 3 clinical trials of BENLYSTA in systemic lupus erythematosus (SLE). HGSI will host a conference call to discuss the results on 7/20/09 at 8:15 a.m. ET.
Disclosure: No positions.